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StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-.

StatPearls [Internet].

Diabetic foot care.

Kayla Song ; Aaron R. Chambers .

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Last Update: July 24, 2023 .

Continuing Education Activity

Proper diabetic foot care is an essential part of limb preservation. Patients with diabetes are at increased risk for foot ulceration secondary to neuropathy, microvascular disease, and biomechanical/anatomical changes. The following activity will provide an overview of performing a proper diabetic foot exam, frequency of visits, anatomical changes of the diabetic foot, special equipment needed, unique disease processes associated with diabetic foot, and the difference healthcare specialties involved in providing care.

Identify the critical anatomical structures, conditions, indications, and contraindications for diabetic foot care.
Describe the equipment, personnel, preparation, and technique in regards to diabetic foot care.
Review the possible complications of poor diabetic foot care.
Outline interprofessional team strategies for improving care coordination and communication to advance diabetic foot care and improve outcomes.
Introduction

Diabetes mellitus is a metabolic disease resulting in increased glucose in the bloodstream. Estimates are that there are 451 million individuals with diabetes worldwide and approximately 5 million diabetes-related deaths in 2017 globally. [1]

Patients with diabetes mellitus are at increased risk for pedal ulceration due to microvascular, neuropathic, and biomechanical changes to the foot. Neuropathic changes to the body result in decreased pedal sensation and make the diabetic foot prone to wounds from pressure, mechanical, or pressure injuries. Microvascular changes can result in reduced blood flow to the lower extremity, and delaying healing of wounds.

Hemoglobin A1c is a marker that reflects average blood glucose levels over a 2 to 3 month period. The American Diabetes Association and International Expert Committee agree that a hemoglobin A1c greater than or equal to 6.5% is the recommended level for the diagnosis of diabetes. [2] An increase in HgA1c of 1% has demonstrated to increase peripheral vascular disease risk by 25 to 28% [3] .

Patients with diabetes are at high risk for lower extremity amputations, higher healthcare costs, and lower quality of life. In a systematic regarding non-traumatic amputations of patients with diabetes mellitus and peripheral vascular disease, the 5-year mortality rate of patients after a below-the-knee amputation was 40 to 82%, and mortality after an above-the-knee amputation was 40 to 90%. [4] [3] Many of these complications are preventable by a thorough annual foot exam and routine foot care performed by the patient.

The purpose of this article is to discuss anatomy, indications, equipment, personnel, preparation, technique, complications, and clinical significance of the diabetic foot.

Anatomy and Physiology

The diabetic foot differs from a normal foot in several ways. Changes to the diabetic foot include musculoskeletal, dermatologic, vascular, and neurological etiologies.

In the musculoskeletal system, a decrease in intrinsic musculature, limited joint mobility, changes in foot type, and ankle equinus, and others all occur in the diabetic foot.

Limited joint mobility of the first metatarsophalangeal joint (hallux limitus) is often present in patients with diabetes, which can be caused by a thickening of the Achilles tendon and plantar fascia. This thickening of the plantar fascia and Achilles tendon leads to a more rigid foot type, increased pes planus, and possible unsteadiness of gait. [5]

The pedal musculature becomes disorganized and infiltrated with adipose tissue as a result of long-standing diabetes. Intrinsic pedal muscles become weaker than extrinsic muscles resulting in foot deformities such as hammertoes or claw toe deformities. [5]

Hammertoes and claw toes along with hallux limitus correlated with increased risk for ulcer occurrence. Bus et al. studied elevated plantar pressures in patients with diabetes with hammer and claw toes and found that plantar metatarsal head pressures significantly increased with increasing toe deformity. They noted that there is a transfer of load from distal to proximal in such toe deformities, with possible distal fat pad displacement as a mechanism. [6]

Searle et al. found that patients with diabetes have a high rate of ankle equinus, defined as less than 5 degrees of ankle dorsiflexion. This condition has correlations with increased forefoot pressure and tissue breakdown, both barefoot and with shoegear. [7]

Dermatologic integrity is one of the most important functions of human skin, but as a result of chronic diabetes, many changes put this critical organ at risk. Autonomic dysfunction as a result of diabetes decreases perspiration in the foot, which leads to increased fissuring and xerosis. [8]

Repetitive stress and pressure to one area, in conjunction with neuropathy, causes inflammation and ulceration. Plantar skin tissue thickness decrease in patients with type 2 diabetes mellitus with neuropathy compared to non-neuropathic patients with diabetes, adding to the increased risk for ulceration. [9] Even once healed, the tissue surrounding former ulceration is at increased risk for rapid breakdown and re-ulceration. [10]

Blood flow to the lower extremity is also an area where diabetes can affect the foot and ankle.

Three main arteries and their branches supply the six angiosomes of the foot and ankle. The posterior tibial artery originates from the popliteal artery and supplies the plantar foot. The peroneal artery originates from the posterior tibial artery and supplies the anterolateral ankle and rearfoot. The anterior tibial artery originates from the popliteal artery and continues into the foot as the dorsalis pedis artery. It supplies the anterior ankle and dorsal foot. [11]

Patients with diabetes have an increased risk of developing peripheral arterial disease (PAD). PAD is the atherosclerotic occlusive disease of the lower extremities. While over half of patients can be asymptomatic, some patients may experience such symptoms as intermittent claudication (aching in lower extremities with activity and relieved with rest) and rest pain, or in more severe cases tissue loss and gangrene.

Neurologically, the foot receives innervation from five main nerves and their branches: the tibial, superficial peroneal, deep peroneal, sural, and saphenous nerves. The tibial nerve originates from the sciatic nerve and divides into the medial and lateral plantar nerves, which further divide into the digital nerves. The tibial nerve provides motor innervation to the posterior lower leg muscles and sensory innervations to the plantar foot and heel. The superficial peroneal nerve (SPN) originates from the common peroneal nerve and branches into the medial and intermediate dorsal cutaneous nerves. The SPN innervates the peroneus longus and brevis muscles and also provides the sensory function to the anterior lower leg and dorsal foot and toes (except for the first webspace). The deep peroneal nerve originates from the common peroneal nerve. It has motor innervations to the anterior compartment muscles and sensory innervations to the first web space. The sural nerve forms from the tibial nerve and peroneal nerve, and it provides sensory innervation to the posterior lateral lower leg and posterior-lateral foot. The saphenous nerve originates from the femoral nerve and provides sensory innervation to the medial-distal leg, ankle, and foot. [12] [13]

A neurological manifestation of diabetes is diabetic neuropathy. [14] Distal symmetrical polyneuropathy is the most common type of diabetic neuropathy. It can involve a combination of sensory or motor neuropathy due to small and/or large nerve fiber dysfunction. Large fiber (A alpha/beta fiber damage) neuropathy is painless paresthesia with reduced sensations in vibration, joint position, touch, pressure, and loss of ankle reflexes. Small fiber (myelinated A-delta and unmyelinated C fiber damage) neuropathy is painful, burning, with reduced pain and temperature sensations.

Diabetic peripheral neuropathy usually starts distally in the toes and progresses proximally. With progression, the patient may start to notice decreased sensation in their upper extremities in a stocking-glove distribution. Symptoms may worsen at night during sleep. Muscle weakness may also develop later in the disease. The exact pathogenesis of diabetic peripheral neuropathy is still the subject of research; however, a major suspect in this process may be chronic hyperglycemia with related metabolic changes leading to a combination of direct axonal injury and nerve ischemia. [15] [16]

A dreaded complication of uncontrolled diabetes and peripheral neuropathy is Charcot neuroarthropathy (CN). This condition is likely the result of both neurovascular changes (i.e., arteriovenous shunting causing increased blood flow and increased bone resorption) and micro-trauma. [17] These changes result in collapsed joints and severe pedal deformities. The most common joint to collapse in CN is the tarsometatarsal joint, which leads to a rocker bottom deformity.

Patients with Charcot foot have a 17% chance annually to develop ulceration. The lower extremity amputation risk for CN patients who have ulceration is 12 times higher compared to patients who have Charcot foot without ulceration. [18] Early detection and treatment of CN improve outcomes; therefore, astute providers should suspect CN when a diabetic patient presents with a warm, erythematous, edematous foot with possible pedal structural changes.

Indications

All patients with diabetes should receive education on proper diabetic foot care. Prevention of diabetic foot complications includes identifying the at-risk foot, daily exam and inspection, patient/family/healthcare provider education, appropriate shoegear, and proper and early treatment of pre-ulcerative lesions. Higher risk patients should obtain a referral to podiatry for management and monitoring. The International Working Group on Diabetic Foot (IWGDF) classification recommends diabetic foot screening by a medical professional [19] :

Once a year for individuals without peripheral neuropathy
Every six months for individuals with peripheral neuropathy
Every 3 to 6 months for individuals with peripheral neuropathy, peripheral arterial disease and/or foot deformity
Every 1 to 3 months for individuals with peripheral neuropathy and history of pedal ulceration or lower extremity amputation
Contraindications

There are no contraindications to proper diabetic foot care.

A basic diabetic foot exam requires minimal specialty instruments and is performable by most primary care, podiatric, or other physicians.

The neurological evaluation requires a Semmes-Weinstein monofilament for neuropathy and protective-sensation testing. A 128Hz-tuning fork can test vibratory sensation, and cotton wool can test tactile sensation. [3]

Vascular testing may require a Doppler ultrasound to assess blood flow.

During diabetic foot care, the caregiver may encounter ulcerations. If ulceration is present and requires debridement or offloading, scalpels, tissue nippers, and offloading padding (e.g., felt pads, foam pads, cushions) should be readily available.

For advanced wound care settings, an array of products should be available: gauze, cleaning solutions (e.g., saline, hydrogen peroxide, acetic acid), topical antimicrobials (e.g., povidone-iodine, cadexomer iodine, silver, medical-grade honey, moisture-retentive dressings (e.g., films, foams, alginates, hydrogels, hydrocolloids), vacuum-assisted closure devices, and bioengineered dressings. [20]

An interdisciplinary approach to managing diabetic foot and its possible complications can reduce amputations up to 85%. Endocrinology, diabetology, vascular surgery, podiatry, orthotics, prosthetics, wound care nursing, and educators are crucial to caring for the diabetic foot. Other specialties that may play roles in diabetic foot care depending on medical issues and infection include infectious disease, nephrology, cardiology, dermatology, and others. Goals should be to medically optimize comorbidities, prevent pedal issues, and treat pedal complications.

Preparation

Patients with diabetes should remove both shoes and socks before the exam. Clean and dry feet thoroughly prior to foot exam or dressing change. If performing a dressing change on a diabetic foot ulcer, wash hands before and after the dressing change. Patients should prepare a clean and sanitary environment to decrease the chances of contamination and infection.

Technique or Treatment

The clinical diabetic foot exam includes four major components: dermatological, vascular, neurological, musculoskeletal.

The dermatological exam includes a thorough evaluation of the entire foot and ankle, including interdigital spaces and nails. Hyperkeratosis requires debriding. Pre-ulcerative and ulcerative lesions need detailed documentation of location, size, depth, the appearance of wound base, peri-wound skin, undermining, tracking, probing to the bone, exudate quality, and signs of infection (e.g., warmth, erythema, malodor, crepitus). A temperature of greater than 3 to 4 degrees compared to the contralateral foot may indicate an infection or acute Charcot neuroarthropathy. Also, a prior history of ulcerations, treatments, and preventative modalities requires documentation. A baseline foot radiograph is in order for patients with new ulcerations, and if osteomyelitis is concerned, the clinician should obtain serial radiographs for monitoring and exclusion. [21]

Clinical evaluation of vascularity and PAD starts with a thorough medical history (e.g., PAD risk factors, claudication, rest pain, history of non-healing wounds). Palpation of dorsalis pedis and posterior tibial arteries are the baseline for diabetic foot exams, but palpation of popliteal and femoral pulses can further assess the level of PAD. A decrease in pedal pulses may warrant evaluation with a Doppler ultrasound or further non-invasive testing for PAD. A Doppler ultrasound of pedal arteries can reveal triphasic flow (normal), biphasic flow (some arterial disease), monophasic flow (PAD with risk for limb ischemia), or absent (severe PAD and high risk for ischemia and limb loss). Non-invasive vascular tests include vascular labs (i.e., ankle-brachial index (ABI), segmental pressures, pulse volume recording, toe pressures, and transcutaneous partial pressure of oxygen [TcPO2]) and treadmill functional testing. The American Diabetes Association (ADA) recommends a screening ABI in patients with diabetes greater than 50 years old, and if normal, a repeat ABI should take place every five years. Screening ABI in patients with diabetes less 50 years old should be a consideration if they also have PAD risk factors (e.g., smoking, hypertension, hyperlipidemia, diabetes greater than ten years). If any indications of PAD are present during these exams, a referral to vascular surgery should follow. [22] [21]

The diabetic foot neurological exam consists of Achilles reflex testing, Semmes-Weinstein monofilament testing (SWMT), 128 Hz tuning fork testing, and pinprick testing. The Achilles reflex is performed on bilateral Achilles tendon with a reflex hammer. Reflexes are graded as 0+ (absent), 1+ (decreased), 2+ (brisk, normal), 3+ (increased), 4+ (increased with clonus). The 5.07/10 g SWMT is the most commonly used monofilament and examines pressure/light touch sensation. It should test for ten sites on each foot as follows: Distal first toe, distal third toe, distal fifth toe, plantar first metatarsal head, plantar third metatarsal head, plantar fifth metatarsal head, plantar medial and lateral arch, plantar heel, and dorsal first interspace. The 128-Hz non-graduated standard tuning fork tests vibratory sensation, and an abnormal result can reveal diabetic neuropathy if the patient can no longer distinguish vibration. The pinprick can be performed with a sharp pin device and evaluates whether the patient can distinguish sharp vs. dull sensations. [23] [24] [25]

Musculoskeletal evaluation should determine lower extremity muscle strength and foot or ankle deformities and limitations. The flexibility and rigidity of the joint range of motion should be determined to guide treatment options. As mentioned previously, patients with diabetes are at higher risk of developing pedal deformities such as digital contractures and ankle equinus, which increases the risk for ulceration. For example, a flexible ankle equinus due to gastrocnemius tightness may result in increased plantar foot pressures and tissue breakdown in the neuropathic patient. Patients with pedal deformities should be referred to podiatry or other surgical practitioners for further management as they may benefit from surgical correction. For example, a digital flexor tenotomy may help in preventing distal toe ulcerations where tissue breakdown has developed. [26]

Patient and family education and enforcement of proper diabetic foot care should be also be provided during the visit. [27]

Patients should understand the importance of ambulating in protective shoegear, both indoors and outdoors. They should wear properly fitted shoes to prevent ulcerations. Additionally, patients with diabetes may require specialized shoegear and should undergo evaluation for such during the diabetic foot exam. The appropriate offloading and protective modality will depend on an individualized assessment of biomechanical changes, pressure points, and pathology. Shoe modifications, temporary shoegear, toe spacers, orthosis, and offloading felt pads or foam may all assist in protecting the diabetic foot. [28]

Complications

Poor diabetic foot care increases the risk of ulceration, infection, and limb loss. Armstrong D.G. and Harkless L.B. found that noncompliant patients, defined as missing greater than 50% of scheduled appointments in 1 year, are 54 times more likely to develop pedal ulcerations and 20 times more likely to have amputations compared to compliant patients. [29] One study found that patients with diabetes fear major lower extremity amputations more than death, foot infection, or end-stage renal disease. [30] Another study found that amputation had the greatest effect on the quality of life when compared to other diabetes complications (i.e., stroke, blindness, renal failure, heart failure, myocardial infarction). [31] Therefore, high-risk limbs require close monitoring and care by specialists such as podiatrists.

Clinical Significance

Proper diabetic foot care is a crucial aspect of diabetes treatment for limb preservation. One of the leading causes of hospitalization and amputation in patients with diabetes is foot ulcerations. The majority of diabetic foot complications result from ischemia, neuropathy, and/or infection. Patients with diabetes and neuropathy have a 7 to 10% chance of developing foot ulceration each year, and the probability increases to 25 to 30% for patients with more risk factors (e.g., peripheral arterial disease, pedal deformities, previous amputation or ulcerations). 85% of amputations on Patients with diabetes are secondary to complications from foot ulcerations. Patients with diabetes over 45 years old are eight times more likely to have an amputation, over 65 years old are 12 times more likely, and 65 to 74 years old are 23 times more likely. [3]

Enhancing Healthcare Team Outcomes

Diabetic foot care requires interprofessional care. The severity of amputation, length of stay, and mortality rates improved in patients receiving care from a team when compared to those who did not. There may also be an improvement in regards to ulcer healing and quality of life. [32] [Level 1]

Proper diabetes management is an essential part of diabetic foot care. In addition to routine management with endocrinology/diabetology, studies show that a group-based self-management education system improves body weight, fasting blood glucose, waist circumference, diabetic knowledge, and triglyceride levels. These monitoring activities can fall between the clinicians, nursing, and pharmacists; in any event, the results and observations require charing and communication with the rest of the team. Interventions done by interprofessional teams with peer supporters improved HgA1c when compared to peer-led groups. [33] [Level 1] Diabetic and foot care nurses are often responsible for foot assessment. They should also educate patients regarding proper foot care. However, all members of the interprofessional team bear responsibility for this training, from nursing to pharmacists, and of course, all clinicians - this interprofessional collaboration can improve patient self-care as well as outcomes, preventing many adverse sequelae as outlined above. [Level 5]

Nursing, Allied Health, and Interprofessional Team Interventions

Intensive patient education (e.g., lifestyle management, podiatric care, proper examinations, callus management) for diabetic foot care by nursing helps prevent diabetic foot ulcerations and decrease the amputation rate for high-risk diabetic feet. Also, intensive education helps to lower plasma glucose, blood pressure, and high-density lipoprotein cholesterol levels. [34]

Nursing, Allied Health, and Interprofessional Team Monitoring

Care for the diabetic foot is an interprofessional responsibility. Holstein et al. found a 75% decrease in major limb amputations in patients with diabetes when establishing an interdisciplinary/interprofessional foot clinic with increased revascularization rates. [35] Primary care physicians and nursing can identify the diabetic foot and provide extensive education on proper care and monitoring. A patient with increased risk factors and pedal deformities should be followed regularly by podiatry. If ulcerations develop, more frequent monitoring may be required and may need a referral to other specialists such as vascular surgery, infectious disease, plastic surgery, and prosthetics.

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Diabetic foot model showing full-thickness ulceration on far left side of picture, and pre-ulcerative lesion on far right. Contributed by Aaron R. Chambers, DPM, FACFAS

T2-weighted MRI image of a patient's right foot. Patient had history of uncontrolled diabetes, peripheral neuropathy and a long-standing ulceration under the 5th metatarsal head resulting in osteomyelitis of the 5th metatarsal head and shaft. Patient (more...)

Xray of a patient's right foot after undergoing partial ray resection of the 5th metatarsal for acute osteomyelitis. Patient had history of uncontrolled diabetes, peripheral neuropathy and a long-standing ulceration under the 5th metatarsal head resulting (more...)

Disclosure: Kayla Song declares no relevant financial relationships with ineligible companies.

Disclosure: Aaron Chambers declares no relevant financial relationships with ineligible companies.

This book is distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) ( http://creativecommons.org/licenses/by-nc-nd/4.0/ ), which permits others to distribute the work, provided that the article is not altered or used commercially. You are not required to obtain permission to distribute this article, provided that you credit the author and journal.

Cite this Page Song K, Chambers AR. Diabetic Foot Care. [Updated 2023 Jul 24]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-.

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http://orcid.org/0000-0002-3611-4224 Andrew Hill 1 , 2 ,
Mairghread Ellis 3 ,
Fiona Gillison 4
1 Health , University of Bath , Bath , UK
2 Health , The Smae Institute , Maidenhead , Windsor and Maidenhead , UK
3 Dietetics, Nutrition & Biological Sciences, Physiotherapy, Podiatry & Readiography , Queen Margaret University , Musselburgh , UK
4 Department for Health, Centre for Motivation and Health Behaviour Change , University of Bath , Bath , UK
Correspondence to Andrew Hill; andrewrhhill{at}gmail.com

Introduction Diabetic foot ulcers contribute significantly to morbidity and mortality associated with diabetes, but are preventable with good foot self-care. This study sought to explore the perspectives of patients and healthcare professionals (HCPs) on barriers and/or facilitators to foot self-care behaviors in diabetes and areas of consensus and/or tension between patient and HCP perspectives.

Research design and methods This was a sequential, qualitative study that used a hermeneutic phenomenological approach. Phase I involved nine in-depth, semi-structured patient interviews. Phase II involved seven in-depth semi-structured interviews with HCPs (podiatrists, diabetes nurses, foot health practitioners (FHPs) and general practitioners (GPs)). In phase III, findings from phases I and II were brought back to two patient interview groups (five patients in total) to try and identify any areas of consensus and tension between HCP and patient perspectives.

Results Patient and HCP perspectives had several areas of alignment: concerns over consequences of diabetes complications; the importance of patient education and frustrations around aspects of health service delivery. There were also some notable tensions identified: mixed messaging from HCPs around whose responsibility patient foot health is; and who patients should initially consult following the development of a foot problem. Overall, patients expressed that motivation to undertake good foot self-care behaviors was generated from their lived experiences, and was enhanced when this aligned with the information they received from HCPs. HCPs appeared to attribute lack of patient motivation to lack of knowledge, which was not raised by patients.

Conclusions This study has identified points of misalignment between the views of patients and practitioners that may help to explain why adherence to foot self-care among patients with diabetes is low. Our results suggest that better outcomes may stem from HCPs focusing on supporting autonomous motivation for self-care and enhancing the rationale through referencing patients’ own experience rather than focussing on increasing patient knowledge. Renewed focus on consistency of messaging by HCPs around the roles and responsibilities relating to foot health in diabetes, and the benefit of foot-specific training being provided to non-foot specialist HCPs may also help to improve uptake and adherence to foot self-care behaviors in diabetes.

diabetic foot
health behavior

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No data are available.

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ .

https://doi.org/10.1136/bmjdrc-2022-003034

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WHAT IS ALREADY KNOWN ON THIS TOPIC

Diabetic foot ulcers (DFUs) contribute significantly to morbidity and mortality associated with diabetes and are extremely costly to health services.

Effective foot self-care behaviors are an important, low-cost approach to reducing the likelihood of DFU development; however, patient adherence to advice is low, and reasons for this remain unclear.

Patients typically only adopt good foot self-care behaviors once DFUs have developed, which is often too late to prevent future occurrence of amputation.

WHAT THIS STUDY ADDS

Patient motivation for foot self-care is generated through personal or vicarious experience and fear about the consequences of diabetes.

Healthcare professionals (HCPs) often focus their time on factors that patients do not link to motivation, such as increasing patient knowledge.

Non-foot specialist HCPs displayed an apparent insecurity around their own foot health knowledge which led them to avoid foot self-care discussions.

There was discrepancy between patients and HCPs about who patients should seek out when a foot problem arises.

HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY

HCPs should support more autonomous motivation for individuals in pursuit of self-care, including: acknowledging barriers; recognising patients’ lived experiences and helping them to develop a personally meaningful rationale for undertaking necessary health behaviors.

There should be renewed focus on developing consistency of messaging by HCPs.

This is both in terms of who the most appropriate HCP is to present developing foot problems to initially, as well as clarifying the roles and responsibilities of HCPs and patients around foot care.

The benefit of foot-specific training being provided to non-foot specialist HCPs should be explored.

Introduction

For a person with diabetes, the lifetime incidence rate of a diabetic foot ulcer (DFU) is between 19% and 34%, with a yearly incidence rate of 2%, and are the leading cause of non-traumatic lower extremity amputations. 1 This is of more striking significance when contextualized by the fact that there is a 45%–57% risk of death within 5 years of a diabetes-related amputation. 2 3 It has even been suggested that preventing DFU development is the way to reduce diabetes-associated mortality. 4 Accordingly, ever-increasing importance is given to strategies aimed at preventing the development of DFUs—so much so that the James Lind Alliance in partnership with the National Institute for Health and Care Research identified this as one of the top 10 foot health research priorities in the UK. 5 Likewise, a Delphi study of key stakeholders in Australia identified that education to improve self-care practices was one of the key priorities for future research to improve diabetes-related foot health and disease. 6 With appropriate disease management and effective self-care behaviors, many complications, including DFUs, are deemed to be entirely avoidable. 1 3 7 8 While the role of the HCP in helping patients to effectively manage their diabetes remains a crucial aspect of diabetes care, the International Working Group on the Diabetic Foot has cited good foot self-care behaviors as a key approach to prevent the development of DFUs. 1 Despite this, a large integrative review identified that HCPs frequently report that foot self-care behaviors are not undertaken consistently enough by people with diabetes. 9 Given the harms and costs associated with diabetic foot disease, all approaches that may help to reduce the incidence and prevalence of this require urgent investigation—not least efficacious and cost-effective measures such as appropriate foot self-care behaviors.

Self-care has been defined as the actions an individual takes in managing the symptoms associated with a chronic condition through physical activity and other lifestyle changes. 10 In diabetes, self-care is a well-established facet of achieving optimal disease management and clinical outcomes because most of the day-to-day care and management of the disease is handled by patients and/or their families. 11 The American Association of Diabetes Educators 12 identified seven essential self-care behaviors in diabetes which predict good outcomes, viz.: healthy eating; being physically active; monitoring blood sugar; compliance with medications; good problem-solving skills; healthy coping skills and risk-reduction behaviors (which includes reducing risk of foot ulceration via good foot care). All of these behaviors positively correlate with good glycemic control, reduction of complications and improvement in quality of life. 11 13–15 Although patients need to be the ones to act, support from healthcare professionals (HCPs) on what to change and encouragement to maintain changes has been shown to increase confidence and facilitate sustained self-care behaviors. 16

Optimal foot self-care behaviors include: daily washing and drying of the feet; daily visual foot examinations; application of skin moisturizer; avoiding walking bare-footed (even within the home); ensuring that bathing water is not too hot; attending regular professional foot care and following professional advice in relation to foot care behaviors. 17–21 Despite self-care being widely considered to be the most cost-effective way of managing diabetes and delaying or preventing of the development of associated complications, it is often found lacking in people with diabetes and is sometimes also underappreciated by HCPs. 22 Evidence indicates that foot self-care behaviors, specifically, remain underused in the prevention of DFUs. 9 11 17 23–25 Mogre et al 26 undertook the only large systematic review to date that included adherence to foot self-care behaviors within a range of self-care practices in diabetes. Their review of 72 studies included 10 that specifically looked at foot self-care behaviors in a pooled population of over 1600: 40% of people with diabetes undertook regular foot inspections and just 10% met the criteria of having ‘good’ foot self-care practices. In comparison, adherence rates of 58% for diet; 71% for medication taking and 41% for exercise behaviors were reported. While this review was limited to low-income and middle-income countries, the findings were largely consistent with the literature on foot self-care behaviors in many different countries—including high-income ones. 17 23–25 27

It appears that adherence to recommended self-care is limited at best, and that this is a multidimensional phenomenon involving social, economic, patient-related, health system-related and condition-related factors. 28 In particular, the complex interplay between the known contributory factors of socioeconomic status; patient knowledge; patient education; patient beliefs; social support; HCP-patient interactions and health service experiences is where there is a need for further understanding. 29–34 Additionally, studies that have identified issues of confusion and trust between patients and their HCPs in relation to foot self-care, 32 have not explored areas of consensus and tension that may exist and whether they may contribute toward any perceived barriers and facilitators to foot self-care in diabetes. Therefore, this study sought to explore patient and HCP perspectives on barriers and facilitators toward patient foot self-care behaviors in adults with diabetes currently at low risk of developing a DFU. This demographic is an important one to assess as in the context of diabetes, low-risk populations tend to become high-risk in time and the establishing of good self-care behaviors are more effective if employed earlier in the disease progression. 9 17

Research design and methods

This sequential, three-phased qualitative study explored patient and HCP perspectives on perceived barriers and facilitators to foot self-care behaviors in diabetes. The design of each phase is outlined below. The lead researcher in this study is a podiatrist and so the potential impact of this in terms of influencing participant responses and/or the interpretation of the findings was a key consideration. Accordingly, measures to account for—and minimize the impact of—this potential bias are detailed in the methods below.

Semi-structured interviews relating to foot self-care behaviors and perceived barriers and facilitators to these behaviors were undertaken with individuals with diabetes. In-depth interviews were selected as the most appropriate approach to this phase as they allow for deep and meaningful data to be generated and to obtain the participants’ accounts as personal stories to help drive and shape the meaning of the data that emerge from them. 35 The interview schedule was devised by the lead author based on findings and gaps from past literature review and professional expertise. Once initially designed, this was then refined via discussion between all the authors of the study.

Recruitment and procedure

Participants were opportunistically selected and recruited from Berkshire Healthcare NHS Foundation Trust and interviewed between February and July 2020. Eligibility criteria can be found in table 1 . Access to participants was via a gatekeeper within the trust. This gatekeeper was a diabetes specialist nurse based out of one health centre. Participants were verbally invited to take part during scheduled clinical appointments and provided with a letter by the diabetes specialist nurse gatekeeper. The letter detailed information about the study and had an accompanying consent form and an explanatory participant information sheet. Potential participants were given time to go away and read these forms and decide if they would like to volunteer to take part. If approached individuals decided that they did want to take part in the study, they completed and signed the consent form and returned it to the gatekeeper who, in turn, provided that to the researcher along with contact details of the volunteer(s) who gave consent to be contacted. All participants were reassured that they were free to withdraw from the study at any point and that not participating in (or withdrawing from) the study would not impact on the care that they received. Volunteers were contacted by the lead author, and interviews arranged via telephone or skype, depending on participant preference.

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Eligibility criteria for study participants

Interviews were transcribed, coded and subjected to interpretative phenomenological analysis (IPA). 35 Respondent validation of the transcripts was employed for all participants prior to any analysis taking place. Participants were given 3 weeks to request any corrections be made to their transcripts once returned to them. If no comments were received in this timeframe, it was assumed that the transcript was a true and accurate account of the interview. Next, the lead author familiarized himself with the transcripts, and generated individualized narrative accounts for each case to create detailed experiential themes. Subsequently, any patterns across cases were searched for. The coding was single-phased and undertaken by the lead author following immersion with the raw data. These codes were created by the lead author and presented to the coauthors along with copies of the transcripts and discussion between the authors allowed for these codes to be interrogated. Once refined and agreed, these codes were then clustered into topics, subthemes and themes by the lead author. These, too, were subject to interrogation and discussion among all the authors to ensure that the findings from this phase were dependable and trustworthy and bias from the lead researcher was reduced as much as possible. 35 36 The lead author took a reflective and reflexive approach to the analysis of the data to ensure that his biases were accounted for in the interpretation of the data. Emerging topics and themes from these interviews provided topics to guide the interview schedule for phase II.

A second phase of in-depth, semi-structured interviews about foot self-care in diabetes were undertaken with HCPs. The processes followed for devising the interview schedule was the same as for phase I except that the findings from phase I were an additional basis for some subjects/questions asked in the phase II interviews.

HCP participants were purposively selected and recruited through Berkshire Healthcare NHS Foundation Trust (via an appointed gatekeeper within the trust) and the private sector (via appeals for participants on HCP research volunteer fora) between August and December 2020. Eligibility criteria are located in table 1 . Consent was obtained via potential participants being presented with a participant information sheet and a consent form for them to read, sign and return if they agreed to take part in the study. All participants were reassured that they were free to withdraw from the study at any point. In order to yield HCP perspectives on foot self-care behaviors in diabetes that has not been influenced by the phase I findings, the patient perspectives were only presented to the HCPs in the second half of their interviews. HCPs were given several minutes to reflect on the findings from the patient interviews before these were explored with the HCP participants.

The data from these interviews were transcribed, coded and thematically analyzed using IPA to allow for both a standalone account of the HCPs’ perspectives as well as initial identification of any areas of consensus and/or tension between the HCP and the patient perspectives. The processes followed in the data analysis were the same as they were for phase I. The topics and themes from this phase combined with those from phase I to contribute to the interview schedule for phase III.

The third (III) phase saw phase I and II topics and themes presented back to patient participants for discussion within two patient group interviews. The purpose of this phase was to identify areas of consensus and tension in patient and HCP perspectives on foot self-care in diabetes, and gain patient perspectives of whether these could contribute to low engagement in these practices.

All participants from phase I were invited to take part. As not all phase I participants accepted the invitation, new participants were recruited via Berkshire Healthcare NHS Foundation Trust in order to increase the participant pool. The eligibility criteria; access to participants and measures to obtain valid, informed consent were identical to the process for phase I. The two types of participants (returning, new) were interviewed in two separate groups. The interviews took place between February and March 2021. The processes followed for devising the interview schedule was the same as for phases I and II except that the findings from phase II were an additional basis for some topics/questions asked in the phase III interviews.

The data from the discussion within the group interviews was then transcribed, coded and analyzed using a simple thematic analysis framework consistent with a hermeneutic phenomenological approach. 36 Following the phase III group interviews, respondent validation was once again used for the transcripts (as for phases I and II). Following this, the transcripts were initially coded using codes that were generated during the phase I patient interviews. Using these codes allowed for the identification of topics and subthemes that were consistent with the phase I interviews. However, any new insights that emerged from these group interviews that were distinct from the findings from phase I were coded. If these appeared pertinent to the study aims, they were then collected into codes and, ultimately, themes to be considered. The coding and clustering of topics, subthemes and themes was undertaken by the lead author and openly and continuously discussed with the coauthors to allow for them to be suitably interrogated for trustworthiness and for any researcher biases to be minimized. Furthermore, the reflexive and reflective approach to analysis occurred in phase III as it did for phases I and II.

Details pertaining to the recruited participants for phases I, II and III of this study can be seen in table 2 and table 3 , respectively. All participants names used in this article are pseudonyms.

Phase I and III (patient group interviews) sample characteristics

Phase II (HCP participant) sample characteristics

Patient perspectives

Patient responses derived from phases I and III of the study indicated that they felt that they needed to be motivated and enabled to undertake good foot self-care behaviors.

The main factor that underpinned patient motivations toward foot self-care was concerns over the consequences of diabetes . The concerns that the patients interviewed had about the consequences of their diabetes comprised their personal experiences and history of living with diabetes; stark health messaging from HCPs that attempted to drive home the seriousness of their condition and their vicarious experiences of diabetes (ie, witnessing their loved one’s experiences of serious diabetes outcomes). The patients interviewed connected these experiences with worries and concerns that they had about the consequences of their diabetes and the subsequent vigilance that they have developed about their health (including that of their feet) and associated this experience with their own motivation to adopt appropriate self-care behaviors.

[Ian]: I was very, very ill…I am concerned about what could happen. I am really quite attached to my feet and I do keep an eye on them…given my experiences of diabetes I am quite aware of what can happen. [Felicity]: I saw what my nan went through with it—she lost her leg because she had a sore and she got gangrene and…I think, she had a stroke and I think it was related to her not controlling her diabetes well enough…I feel that I need to make sure that I am looking after myself a lot better.

Those without such personal experience, however, did not appear to consider themselves particularly susceptible to foot problems in diabetes and did not appear to have a personally meaningful reason to adopt foot self-care behaviors. Indeed, they appeared to question the veracity of the foot self-care advice they were given as it did not align with their own lived experiences.

[Arthur]: I didn’t know I had diabetes and I still don’t know I have diabetes. Except now they are telling me that I am losing some sense in my feet…I don’t notice any difference. I can’t see what they’re telling me about my diabetes…I don’t think I would cream my feet. Not unless somebody could give me a very good reason why…I cannot see any reason why I should start creaming them.

Patients talked about two criteria that needed to be met for them to feel able to adopt self-care recommendations; being informed and being resourced .

‘Being informed’ was noted in the testimonies of those who spoke positively about their experiences of targeted patient education as well as those who bemoaned a perceived lack of it.

[Erica]: I have had a lot of information and a lot of help from the doctor and nurse that I see. The DEAL course was also excellent. In fact, the importance of moisturising your feet was something that came up in that course and I do now keep my feet creamed. So, I think that the discussion that we all had about that and the nail cutting and things like that have definitely been helpful. [Felicity]: As you are not seeing the same doctors all the time and the ones you see may not always tell you everything, so having something that you get when you are newly diagnosed or whatever that covers everything would be really good. If you don’t know what you should be doing you often end up doing nothing in case it is wrong.

‘Being resourced’ as a contributory means of undertaking foot self-care behaviors covers both external resources and personal resources. Patients identified their need for external resources such as an effective working relationship with HCPs and help afforded by technological/specialist equipment.

[Brenda]: I have always felt that if I am worried about something, there was always somebody at the practice that I could go to, to ask. When I do, they would see me, they would check whatever it was that I was concerned about and, sort of, reassure me… That’s been good. [Ian]: Now I use a Dexcom G6 glucose blood monitoring system. That is amazing and it really has improved my life beyond belief. Not only that but my wife has the App on her phone as well and so I am incredibly secure in the knowledge that I am a lot safer now…the technological solutions have been fantastic and have really improved my life drastically. More than anything else.

The personal resources they considered important included time and the physical capability to tend to the feet.

[Brenda]: Everything always seems to be done in a rush. So that is one thing that I have found—that it has been difficult to manage time. [Harriet]: I also have a bad back so I cannot get down to my feet that easily, so I find that I cannot cut my nails and as you get older your nails get stronger. I also have arthritic hands.

Healthcare professional perspectives

The two main themes to emerge from the interviews with the HCPs centred around ‘HCP beliefs about patient self-care behaviors’ and their ‘perceived barriers to effective care’ .

Healthcare professional beliefs about patient self-care behaviors

HCP beliefs about what predicts foot self-care behaviors, and their awareness of patient-specific circumstances played a role in shaping how they sought to optimize the care they provided. Four predictors for self-care behaviors that may influence practice were raised by HCPs based on their clinical experiences: the state of the patients’ glycemic control; patient age; diabetes type and patient fear of the consequences of diabetes complications . Of these, only fear of the consequences of diabetes complications was recognized by all the HCPs interviewed. Furthermore, some of the HCPs interviewed assumed that fear of consequences is associated with motivation and therefore considered it logical to use stark health messaging as a means to increase patient motivation.

Pamela (GP): I think it can be quite simple in many ways, if people are concerned or worried about a particular aspect of their health then they’re probably concerned enough to follow through on the treatment or advice that you give them. It makes the conversation easier in many ways.

HCPs demonstrated awareness of patient-specific circumstances that could impact on self-care behaviors, which included recognition that physical limitations and psychological difficulties can seriously affect somebody’s ability to undertake effective self-care behaviors. Some of the HCPs discussed how they had tailored their communication and practices to more effectively advise and guide patients, differentiating according to each patient’s situation.

Jessica (nurse): My advice depends very much on the person because sometimes something that I might consider to be really simple could actually be quite a mind-set change for some people…I mean just because it is easy for me does not mean that it will be easy for them and so I need to shape my advice with that in mind.

Perceived barriers to effective care

HCPs expressed frustrations about what they perceived to be barriers to effective care, which they believed influenced their practice. These were: patient attitudes and behavior; a lack of effective, consistent patient education; service limitations and an insecurity of own foot health knowledge .

HCPs differed in their opinions around the division of foot care responsibilities, with some HCPs bemoaning a lack of patient self-care behaviors, implying patients did not take on enough personal responsibility, while others indicated that patients did not bring foot health problems to the attention of HCPs and seek professional advice early enough.

Kevin (podiatrist): You do get the ones who won’t do what you have asked and instead would just happily come back to see you and let you do it even if you tell them a hundred times that they need to do it every day…Yeah, it gets a bit frustrating. Mary (podiatrist): We are always trying to advise them to call us asap if there are any problems or any warning signs, but…the amount of times that we have had people come in with sepsis and they have been ill for a week or so and just didn’t call us even though we have told them time and time again. It is like it just goes over their heads. I find it quite hard and frustrating.

There were also differences in beliefs around the reasons why current service provision does not result in sufficient foot self-care; some HCPs perceived this to stem from the lack of effective and consistent patient education.

Mary (podiatrist): Patients first get screened by nurses and maybe healthcare assistants, and I think that education should start there regarding their feet as I am not sure that it really does currently. I mean, a lot of them do not know about foot ulcers and until they come to us for one thing or another and then I may say to them “do you know what a foot ulcer is?” and they don’t have a clue.

Mary further pointed to the inconsistency of professionals managing the foot in diabetes as a contributory factor to barriers to effective foot care in diabetes:

Mary (podiatrist): Sometimes these patients don’t get that consistent education or someone who they’ll see consistently who will be there for them as support. Also, you get a clash of clinician advice and that makes it really difficult. Different people changing the dressings and different people have different ideas of how to manage it and that makes it difficult for the patient as well.

The non-foot specialist HCPs interviewed (ie, diabetes specialist nurses and GPs) indicated a further barrier, of being insecure about their foot health knowledge, which was a key reason that these practitioners did not speak to patients about foot health more frequently. Instead, they tended to signpost patients toward podiatrists for foot-specific advice and guidance, despite finding that getting patient access to podiatrists was not always easy or possible.

Omar (GP): I’d typically pass foot problems to the Podiatry department and they would be the ones more focused on the foot care practices of the individuals concerned. The nurses may play more of a role there too. Jessica (nurse): I know that it is the bit that is sometimes difficult—you know, timely access to healthcare professionals…I think it is really quite easy for small wounds to escalate to something more serious because people will not have ease of access to care sometimes.

This study sought to explore the perspectives of patients and HCPs on barriers and/or facilitators to foot self-care behaviors in diabetes and areas of consensus and/or tension between patient and HCP perspectives. While previous studies have found that foot self-care behaviors in diabetes may be influenced by how much concern people have about their feet, this is the first study that the researcher is aware of that has been able to expressly link motivation to these behaviors from patients’ personal and vicarious experiences. Moreover, other apparently novel findings from this study were that: HCPs often focus their time on factors that patients do not link to motivation (such as increasing patient knowledge); non-foot specialist HCPs displayed an apparent insecurity around their own foot health knowledge which led them to avoid foot self-care discussions and that there was discrepancy between patients and HCPs about who patients should seek out when a foot problem arises.

The finding that motivation toward self-care is influenced by the amount of concern an individual feels toward the aspect of their health in question is consistent with past qualitative studies seeking to understand the perspectives of people with diabetes. 37–39 However, the consideration that this concern is a product of past experience (personal or vicarious) and that HCPs warnings and advice relating the importance of self-care is likely enhanced if their messages reflect these patients’ lived experiences appears to be a novel contribution of this study to the literature.

Around the theme of enablement arose the notions of being informed and being resourced . A closely intertwined relationship between self-efficacy and being suitably informed has been found in previous studies, 40 41 where the confidence persons have in their own ability to perform a task tracked closely with how well they felt they have been educated about performing that task. Connecting back to the other theme of motivation , it emerged strongly in our patient interviews that those who had the greatest levels of concern around diabetes consequences were the ones who reported seeking out information. This could suggest that for these individuals, information seeking provides a possible connection between motivation and enablement in the context of self-care behaviors. As patients acknowledged the importance of both motivation and enablement for them to be more likely to undertake good foot self-care behaviors, these findings highlight that these factors may be separate, yet interdependent. This is consistent with the capability-opportunity-motivation-behavior model in which motivation and enablement (capability) are presented as being two of three central factors which are needed for any particular behavior to emerge. 42 On a practical level, awareness of this dynamic could mean that HCPs seek to appraise factors of both motivation and enablement (rather than either/or) in any given patient context to see if practical support and advice could help patients initiate and sustain good foot self-care behaviors.

HCP perspectives

The two main themes from the interviews with the HCPs centred around HCP beliefs about patient self-care behaviors and their perceived barriers to effective care . HCP beliefs about patient self-care behaviors most frequently linked poor adherence of patients with a lack of motivation and, consequently, they focused their communication around ways to improve motivation; yet few reported exploring this assumption with patients (eg, asking them if they struggled to find motivation) as noted in previous studies. 43 This suggests that some of the HCP’s efforts to try and increase motivation were not informed by patients’ views which may go some way to explaining the proclivity some HCPs had toward stark health messaging, even if the effectiveness of this strategy is not evident in the literature. 44 Indeed, patient participants in our study indicated that they often found stark health messaging to be unhelpful and demotivating.

The perceived barriers to effective care that HCPs offered varied, including: differing perspectives on the division of foot care responsibilities; a perceived lack of effective and consistent patient education; limitations to service delivery; inconsistent personnel; ineffective communication between HCPs and non-timely access to specialists. It is plausible that the differences between HCPs’ views could contribute to the mixed messaging perceived by some of the patients in this study. In turn, this may create uncertainty for patients regarding the division of responsibility for aspects of their foot care. A study by McInnes 45 that explored diabetes-related foot care knowledge of podiatrist and non-podiatrist HCPs also reported a lack of consensus between these groups, and more incorrect beliefs and understandings about foot health in diabetes among non-podiatrists. Aligned with the findings of our study, this may be an area worthy of further research as this could suggest that patients are not being routinely steered toward foot health conversations with the HCPs they present to most often and may not be getting early or frequent enough access to the HCPs best placed to have these conversations with them (podiatrists).

Areas of consensus and tension

Figure 1 diagrammatically presents the areas of consensus and tension between patient and HCP perspectives. In this study, consensus between participant groups is determined as having occurred where the general points made by participants are consistent with each other, with few areas of disagreement. Across the patient and the HCP interviews, the four main areas of consensus between these participant groups were: concerns over consequences; importance of patient education; importance of effective patient-HCP communication and frustrations related to the health service .

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Areas of patient and HCP consensus/tension of perspective and its relationship with barriers and facilitators to good foot self-care behaviors. HCP, healthcare professional.

Alignment in perspectives between patients and HCPs may increase the productivity of the interactions between them in consultations, which may lead to increased quality of care and patient outcomes. 46 Also, shared perspectives are believed to foster greater understanding and shared goal-setting, which are crucial to the establishment of an effective therapeutic alliance between patients and HCPs. 47 Given the areas of consensus highlighted in this study, using shared perspectives to facilitate more effective communication between patients and HCPs could increase quality of patient care and help patients become suitably motivated to undertake and sustain good foot self-care behaviors. For instance, HCP communication could demonstrate an understanding of the concerns that patients may have; provide a means of explaining how their advice may help prevent those concerns from becoming a reality; show empathy and cognisance of the experiences and challenges faced by the patient in incorporating advice into undertaken behaviors, and do so in a way that seeks to avoid making assumptions and judgments about patients. 36 43 46 47

‘Tension’ relates to where there were areas of disagreement and ambivalence in perspectives between the groups interviewed (patients and HCPs). The four main areas of tension within and between these participant groups were: patient attitudes and behaviors (ie, a perception of them as lacking motivation); the initial point of contact regarding foot problems; questions over HCP knowledge (ie, disparate perceptions regarding HCP knowledge of foot-specific issues) and thoughts around stark health messaging . Divergent beliefs between patients and HCPs can affect care through competing therapies; fear of the healthcare system and/or distrust of the medical professionals and/or their prescribed therapies. 48 The suggestion is that differences in beliefs may negatively affect treatment decisions and, ultimately, patient outcomes. Of particular interest was the area of tension around differences in perspective over who the initial point of contact should be for an emergent foot problem. The HCPs interviewed all expressed that this should be a podiatrist while the patients more commonly indicated that they would take emergent foot problems to their GP initially. When set against other key areas of tension —confusion over division of foot health responsibility and questions over the HCP knowledge on foot health in diabetes —this may help to identify why some patients may not be getting timely specialist advice and attention for developing foot health problems in diabetes. How these areas of tension may ultimately impact on the provision of care is that differences in beliefs between patients and HCPs have been widely cited to negatively affect treatment decisions and, ultimately, patient outcomes. 32 43 46–49 In consideration of the practical implications of these findings, the following suggestions relate to practice improvements and areas where further research may be needed: (1) HCPs should recognize that individuals differ in how they respond to different rationales. Some respond more favorably to gain-framed messaging, whereas others may respond more favorably to loss-framed messaging. 50 Recognizing this dynamic should encourage HCPs to develop more flexibility in their approaches to their communication with patients; (2) there should be renewed focus on developing consistency of messaging by HCPs. This is both in terms of who the most appropriate HCP is to present developing foot problems to initially, as well as clarifying the roles and responsibilities of HCPs and patients around foot care; (3) the benefit of foot-specific training being provided to non-foot specialist HCPs should be explored. This would be with a view to help build knowledge and confidence in this area for non-foot specialist HCPs so that patients may more routinely be steered toward the topic of foot health conversations. Furthermore, this may help build patient trust and confidence in these HCPs that they are providing accurate information to patients. 32

Limitations

This study was conducted in an affluent part of the south of England and may not reflect the views and experiences of all patients in differing areas of the country, across varying socioeconomic contexts. The healthcare experiences of individuals are known to vary quite substantially between NHS trusts and regions and so this may not reflect the national picture. The small sample size of each group of participants cannot reflect the whole population or be generalizable in a quantitative sense, nor was it intended to. In particular, the patient participants represented a largely homogenous ethnic make-up (white British), meaning that experiences of different ethnic minorities may be quite different to the experiences identified here. In terms of the HCPs, while there was a useful sample of different HCP disciplines represented in this study, it would have been preferable to have had slightly wider engagement from other HCPs also involved in the delivery of care to people with diabetes. Finally, as the researcher is a podiatrist and this was known to all participants in this study, it should be recognized that this may have had a degree of influence on some of the participants’ responses as well as the analysis of the findings. However, engagement with reflexive research practice, reflection, respondent validation and the aid of the study supervisors in cross-checking the codes and themes as they were created (as detailed in the ‘Research design and methods’ section) have helped to reduce potential biases of the researcher.

This study sought to explore patient and HCP perspectives on the barriers and facilitators to foot self-care behaviors in diabetes, and explore whether any areas of consensus and/or tension in these perspectives contribute to these perceived barriers and facilitators. In so doing, this study has identified points of misalignment between the views of patients and practitioners that may help to explain why adherence to foot self-care among patients with diabetes is low. Our results suggest that better outcomes may stem from HCPs focusing on supporting autonomous motivation for self-care and enhancing the rationale through referencing patients’ own experience rather than focussing on increasing patient knowledge. Renewed focus on consistency of messaging by HCPs around the roles and responsibilities relating to foot health in diabetes, and the benefit of foot-specific training being provided to non-foot specialist HCPs may also help to improve uptake and adherence to foot self-care behaviors in diabetes.

Ethics statements

Patient consent for publication.

Not applicable.

Ethics approval

This study was approved by The University of Bath and through Health Research Authority (IRAS ID: 266394). Participants gave informed consent to participate in the study before taking part.

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Contributors AH undertook the literature review, undertook the research and lead on the write-up of this paper. All authors contributed to the conceptualization of the study design, creation of the interview schedules and analysis of the findings. ME and FG contributed to the write-up in an editorial capacity. AH acts as the guarantor for this study.

Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

Competing interests None declared.

Provenance and peer review Not commissioned; externally peer reviewed.

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Published: 20 March 2020

Diabetic foot care: knowledge and practice

Aydin Pourkazemi 1 ,
Atefeh Ghanbari ORCID: orcid.org/0000-0002-7949-5717 2 ,
Monireh Khojamli 1 ,
Heydarali Balo 1 ,
Hossein Hemmati 1 ,
Zakiyeh Jafaryparvar 1 &
Behrang Motamed 3

BMC Endocrine Disorders volume 20 , Article number: 40 ( 2020 ) Cite this article

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Diabetic foot ulcers (DFUs) are common problems in diabetes. One of the most important factors affecting the quality of diabetes care is knowledge and practice. The current study aimed at determining the knowledge and practice of patients with diabetes regarding the prevention and care of DFUs.

The current analytical, cross sectional study was conducted in Guilan Province (north of Iran) on 375 patients registered in the medical records as type 2 diabetes mellitus. Demographic characteristics, knowledge, and practice of participants were recorded in a questionnaire during face-to-face interviews conducted by the researcher. Descriptive and inferential statistics were performed using SPSS version18.

The mean score of knowledge was 8.63 ± 2.5 out of 15, indicating that the majority of participants had a poor knowledge (84.8%). The mean practice score was 7.6 ± 2.5 out of 15, indicating that a half of them had poor performance (49.6%). There was a significant and direct correlation between knowledge and practice. Knowledge level, place of residence, marital status, and history of admission due to diabetic foot were predictors of practice score.

Conclusions

According to the low level of knowledge and practice in patients with diabetes regarding the prevention and care of DFUs, and considering the significant relationship of some demographics of patients with knowledge and practice scores, a targeted educational program is needed to promote knowledge of patients with diabetes.

Peer Review reports

What is already known about this subject?

Diabetes accounted for 1.3 million deaths (2.4% of all death). The prevalence of diabetes varies among countries in Eastern Mediterranean Region (EMR).

Prevalence of diabetes mellitus in Iran ranged 20 to 30% in different provinces with higher frequency among females from 1990 to 2013.

Among people living with diabetes mellitus, 20% are at risk for foot ulceration as a result of neuropathy.

Diabetic foot ulcers (DFUs) are one of most common diabetes complications with 0–4% prevalence.

Good knowledge and practice regarding DFU reduces the risk of diabetic foot complications and ultimately amputation.

What are the new findings?

- In the current study, 84.8% of the participants had poor knowledge and only 8.8% had good practice. There was a direct and significant correlation between knowledge and practice.

The lowest knowledge scores belonged to the use of talcum powder or other powders and not using lotions between the toes.

The strongest variables related to practice were knowledge, place of residence, marital status, and history of admission due to diabetic foot, indicating that these four variables were the predictors of practice score.

How might this impact on clinical practice in the foreseeable future?

Patients’ knowledge about foot ulcer prevention should be promoted based on guidelines both in community and hospitals.

Adherence to guidelines prevents DFU; targeted interventions directed toward patients/health care providers can lead to reduced DFU complications.

Diabetes mellitus is a group of common metabolic disease characterized by hyperglycemia. Due to multiple and prolonged complications, diabetes affects almost all systems of the body [ 1 ]. Diabetes caused 1.3 million deaths (2.4% of all death) and 56 million disability adjusted life years (DALYs) in 2013. The diabetes DALY rate increased from 589.9 per 100,000 in 1990 to 883.5 per 100,000 populations in 2013. Total DALYs from diabetes increased by 148.6% during 1990–2013; population growth accounted for a 62.9% increase, and aging and increase in age-specific DALY rates accounted for 31.8 and 53.9%, respectively [ 2 ]. The prevalence of diabetes varies among countries in EMR. In Saudi Arabia, the prevalence of diabetes was reported 13.4% Saudis aged 15 years or older [ 3 ] and in Pakistan 12.1% for males and 9.8% for females aged ≥25 years [ 2 ]. A systematic review on the prevalence of type 2 diabetes in Iran showed a range of 3 to 20% in different provinces [ 4 ].

Of people living with diabetes, 20% are at high risk of foot ulceration as a result of neuropathy [ 5 ]. Diabetic foot ulcers (DFU S ) comprise 12–15% of total estimated cost of diabetes in the developed countries, increasing to 40% in the developing countries [ 6 ]. DFUs are one of the most common diabetes complications with 4 to 10% prevalence in the affected population [ 7 ]. The overall incidence of DFU is 5.8–6.0% in some particular diabetic in the U. S, while it is 2.1–2.2% in smaller populations in Europe [ 8 ]. Treating foot ulcers can be expensive and it is evident that about 49–85% of all DFU S can be prevented by raising awareness and taking proper measures [ 7 ]..

Among the complications of diabetes, DFU S affects the patient’s quality of life in case of amputation. However, it is possible to prevent amputation using educational and care strategies [ 9 ]. Data show that 25% of patients with diabetes develop a foot ulcer in their lifetime and that the cost of treating a DFU S is more than twice that of any other chronic ulcer [ 10 ]. Diabetic foot amputation remains an unpleasant impact on patients’ life more than other complications [ 11 , 12 ]. Delays in referral of serious foot problems are of particular concern [ 5 ]. Ndosi et al., reported that 15.1% of patients died within the year of presentation, the ulcer had healed in 45.5%, but recurred in (9.6%). Participants with a single ulcer on their index foot had a higher incidence of healing than those with multiple ulcers (hazard ratio 1.90, 95% CI 1.18 to 3.06) [ 13 ].

Understanding the level of knowledge and practice in patients with diabetes is important in planning for the better control of diabetes and its complications. A study by Ahmad and Ahmad on 124 patients with diabetes in North India reported that 60.5 and 79.0% got lower scores in knowledge and practice toward diabetes, respectively [ 14 ]. Jackson IL et al., reported that 79.5% of patients with diabetes in Nigeria had more than 70% of overall knowledge about self-care [ 15 ]. The results of a study in Malaysia showed that the most patients (58%) had poor knowledge and 61.8% of them had poor practice of foot care [ 16 ].

Among diabetes complications, the foot ulcers are considered as the most preventable ones. Risk factors of DFU S are correlated with poor practices and knowledge. Good knowledge and practice toward diabetic foot care reduces the risk of diabetic foot complications and ultimately amputation [ 7 ]. According to American Diabetes Association, annual assessments of knowledge, skills and behaviors are necessary for patients with diabetes [ 15 ].. The current study was conducted to assess patients’ knowledge and practice toward diabetic foot care. No similar study is conducted in Rasht City (the capital of Guilan Province, Northern Iran) thus far; therefore, the present study aimed at evaluating the level of practice and knowledge toward foot care in patients with type 2 diabetes mellitus. Health system can prevent DFU and amputation by applying a strategy to raise knowledge in patients.

Study design and subjects

The current analytical, cross sectional study was conducted at a clinic in Razi Hospital, affiliated to Guilan University of Medical Sciences, which is the only endocrine disease referral center across the province. Data were gathered from May to July 2017 and the subjects were selected by consecutive sampling. To Diagnostic and classify the patients, the American Diabetic Association, the diagnostic criteria were utilized [ 17 ]. Patients with diabetes receive care, education, treatment, and other services at this center. The center also delivers healthcare services to outpatients and inpatients, as well as routine training. The research project was approved by the Deputy of Research, Guilan University of Medical Sciences. Participation in the study was voluntarily and the subjects were informed about their right to withdraw from the study at any stage. The participant’s privacy was respected, and data were kept confidential and utilized for study purposes only. Participants were asked to read and sign an informed consent form. Inclusion criteria were: receiving the diagnosis of type 2 diabetes mellitus, age 18 years or above, taking anti-diabetic medications for at least 1 month prior to the study, having clinical records at the center, and willing to participate in the study. The exclusion criteria were: critically ill patients with diabetes, pregnant or newly diagnosed (less than 1 month) patients, receiving any other treatment or therapy, and having major psychiatric problems. A structured datasheet was used to collect demographic and clinical information of the patients using paper-based and digital records archives. Some information was also collected by a medical student through face-to-face interviews. A paper-based questionnaire was distributed among both outpatients and inpatients. Wagner DFU classification system was used to classify the patients based on ulcers. In this hospital, we assessed peripheral neuropathy, retinopathy and peripheral vascular disease (PVD), respectively by using monofilament testing, optometrist or ophthalmologist reports and the clinical diagnosis documented by the surgeon or, if available, images taken through arterial Doppler or angiography. Macro vascular disease was defined as any macro vascular complications other than PVD including prior myocardial infarction, angioplasty, coronary artery bypass grafting, ischemic heart disease, or stroke [ 18 ].

In the current study, having one or two more complications was considered a positive condition. The sample size was determined 375 considering 95% confidence interval with d = 0.05 and P = 0.58. A total of 375 out of 395 distributed questionnaires were completed and returned; the response rate was 94.4%.

A three-section questionnaire was used in the current study. First section included demographic characteristics such as age, gender, and duration of diabetes mellitus, place of residence, occupation, and level of education, marital status, and body mass index. Second part consisted of 15 questions about knowledge scored based on nominal (yes/no/I don’t know) scale, and third part with 15 questions focusing on practice was scored based on “yes/no” scale. The questionnaire was used to measure the level of knowledge and practice of subjects toward diabetic foot care. Patients’ demographic data were collected to analyze factors associated with knowledge and practice toward diabetic foot care. Each correct answer was given 1 point; however, wrong answers or choosing “I don’t know” option was given 0 point. The total score for each part ranged 0 to 15. Good or poor level of knowledge was determined based on the 75% of the maximum score of the questionnaire; therefore, the scores higher than 11.25 were considered good and those lower than 11.25 were considered poor. Examples of the questions included “Do you care about your diabetes?”; “Do you wash your feet every day?”; “Do you check the water temperature before using it?” and “Do you dry your feet after washing?”

The questionnaire was translated into the Persian language. Following the translations conducted by an Iranian professor of English literature, a native bilingual English speaker translated it back into English. Content validity was determined by gathering the views of 15 medical and nursing professionals after reviewing the questionnaire. Content validity ratio (CVR) and content validity index (CVI) of the questionnaire were assessed. Mean scores of CVI and CVR were higher than 0.80. Cronbach’s α coefficients were computed to evaluate reliability of knowledge and practice, which were 0.80 and 0.85, respectively.

Statistical analysis

After collecting data, descriptive statistics (frequency, mean, and standard deviation) were employed to summarize patients’ socio-demographic data and Chi-square test to investigate association between predictors (factors) and knowledge and practice level. In order to assess the differences between groups, the Wilcoxon, Mann-Whitney, and Kruskal-Willis tests were used for continuous variables. Factors related to knowledge and practice was estimated by multiple regressions. In this research, wrong answers and “I don’t know” merged as poor awareness. In order to assess the relationship between individual variables with knowledge and practice, we had to integrate these two items in order to have a better analysis. Variables with a P -value of < 0.1 were included in the multi-variate models. P -value < 0.05 was considered as the level of significance. All analyses were performed using SPSS version 18.

The mean (± SD) age of the 375 participants was 55.4 (±12.9) years, and 56.4% were female. Majority of patients had diabetes for less than 10 years (54.1%), were female (56.5%), urban residents (62.1%), illiterate or had elementary education (73.1%), did not have normal BMI (69.8%), and (10.6%) patients had 2 and more complications (Table 1 ). In terms of knowledge, only 57 participants (15.2%) had good knowledge, most of them (84.8%) had poor knowledge, and the mean score of patients’ knowledge was 8.63 ± 2.65. The highest percentage of correct answers was found with the knowledge about “The need for meeting or consulting a physician, if there were signs of wounding” (88.8%), followed by “Not walking without shoes” (83.5%) and “Washing and changing socks” (9.81%). The lowest knowledge was about “The use of talcum powder or other powders between the toes” (3.5%), followed by “Not using lotion between the toes” (22.24%), and “The proper method of trimming the toenails” (23.2%).

In terms of practice, only 33 patients (8.8%) had a good practice; most of them (91.2%) had a poor practice (Table 2 ), and the mean score of patients’ practice was 7.6 (± 2.5). The participants reported their best practice toward “Importance of diabetes control” (80.5%), followed by “Meeting or consulting a physician, in case of signs of DFU” (79.2%). The poorest practice was toward “The use of talcum powder between the toes” (2.7%), followed by “Proper method of trimming the toenails” (25.9%), and “Keeping the foot skin soft” (30.9%).

There was a direct and significant correlation between knowledge and practice ( P < 0.0001, r < 0.8) (Fig. 1 ). There was a significant relationship between knowledge score and gender, duration of diabetes, occupation, level of education, place of residence, having DFU, hospital stay history, and amputation history.

Correlation Between Khowledge and Practice

The study results showed that patients with more than 10 years history of diabetes, history of DFU, history of hospital stay or experience of lower limb amputation due to DFU, female gender, and the ones with complications had higher knowledge ( P < 0.05).

There was a significant correlation between practice score and gender, duration of diabetes, occupation, level of education, and place of residence (P < 0.05) (Table 3 ).

Also, based on multiple regression, the strongest variables related to practice were knowledge score ( P < 0.0001), place of residence ( P < 0.03), marital status ( P = 0.008), and DFU ( P = 0.02), indicating that these four variables were the predictors of foot care practices in the current study (Table 4 ).

In the current study, majority of patients with diabetes had lower levels of education. Studies report that level of knowledge depends on the level of education [ 14 , 19 ]. Understanding this variable is highly important in designing strategies to prevent diabetes.

In the current study, most patients had lower scores of knowledge and practice toward foot care, and the mean practice score was lower than the mean knowledge score, which was similar to the findings of Muhammad-Lutfi’s and Kim’s studies [ 16 , 20 ]. A study conducted on patients with diabetes in Western Nepal reported poor KAP (knowledge, attitude and practices) score; they indicated that the plausible factors could be lack of knowledge, lack of information, and literacy level of the studied population [ 21 ]. Another study on young Saudi females with diabetes also reported poor KAP scores [ 19 ]. Some studies reported that patients with diabetes had good level of knowledge about diabetes [ 7 , 16 , 22 , 23 ]. The differences in knowledge about foot care among patients with diabetes across the studies could be due to different trainings on diabetes care provided by the health care professionals in different settings [ 23 ] and also the literacy level of the studied subjects.

Several studies reported poor foot care practices among patients with diabetes. Kheir et al., reported poor practices toward regular inspection of feet among patients in Qatar [ 24 ]. Hamidah et al., from Malaysia observed that 28.4% of patients newly diagnosed with diabetes practiced good habits towards foot care [ 25 ]. Desalu et al., from Nigeria observed that only 10.2% of patients with diabetes had good foot care practices [ 26 ]. It was difficult to compare the results of the current study with those of other studies since the nature of the study populations and the applied measurements were different.

In the current study, there was a direct and significant correlation between knowledge and practice scores; therefore, with an increase in the knowledge score, the practice score also increased. Other studies also showed that patients who receive trainings on foot care checked their feet regularly [ 20 ]. Patients who are advised to take care of their feet and the ones whose feet are regularly checked by physicians have better practices toward foot care [ 27 ].

In the current study, the lowest knowledge scores were regarding the application of talcum powder or other powders and not using lotions between the toes, and the proper way of trimming the toenails; while the lowest practice scores were related to the application of talcum powder between the toes, the proper way of trimming the toenails; keeping the foot skin soft, and avoid dryness.

It should also be noted that due to wet climate in the North of Iran, use of lotion between the toes is not common. Nevertheless, it also needs training. Patients with diabetes need to keep between their toes dry using talcum powder and avoid the application of lotion since it is important as a hygienic measure for feet in preventing fungal infection [ 28 ]. Patients should also use skin moisturizers daily to keep the skin of their feet soft and should trim their toenails straight across (not rounded) to prevent damage to their toes [ 29 ].

In the current study, gender, duration of disease, occupation, place of residence, level of education, having DFU, and a history of hospitalization, amputation, and complication had significant relationships with knowledge. Also, gender, duration of disease, place of residence, occupation, and level of education had significant relationships with practice. It was found that knowledge level was higher in females, patients with a diabetes history of more than 10 years, and the ones underwent amputation due to DFU compared to the others; in addition, females, patients with a diabetes history of more than 10 years, and urban residents had better performance. The current study results showed that males were usually reluctant to disclose their health problems and seek professional care. Also, males presented greater deficit in self-care compared to females [ 30 ].

In the study by Muhammad-Lotfi, age, gender, level of education, and duration of diabetes had no significant relationship with knowledge and practice. This finding was in agreement with that of the current study [ 16 ], but another study indicated a significant relationship between the level of education and knowledge [ 31 ].

People with higher education are expected to be more likely to read and receive information about their illness and foot care and understand the information provided by medical staff in health care settings.

But in the current study, there was no significant relationship between the level of education and knowledge or practice, which could be due to the poor and inadequate resources of information about diabetes at the community level, since both educated and uneducated groups had inadequate information. It may also be due to the fact that in spite of possessing knowledge, due to the lack of time, heavy work load, and lack of adequate insurance coverage, patients could not take good care of their feet in practice, which requires more studies to root out the causes.

Nevertheless, the attitude of patients toward self-care in addition to sufficient knowledge was not studied in the current study. As observed in the present study, patients with a history of DFU or hospital stay, and even amputation and complication had higher knowledge level. It could be due to the fact that while completing the questionnaire, the current knowledge level of the subjects was questioned, which indicated that training medical centers can raise the level of knowledge in patients with DFU. In many Iranian state hospitals, diabetic training programs are not well organized, and the existing programs are weak. It is believed that knowledge about diabetes in the general population as well as patients with diabetes in Iran is not enough and there is a dire need for a good program for diabetes [ 32 ].

The collected data indicated that patients with diabetes had poor practice and knowledge about foot care. This is basically due to lack of proper communication between patients and medical team and inadequate education. Based on nurses’ opinion, recommendations and guidelines play an effective role in prevention, treatment, and reduction of complication among patients with DFU. Therefore, adaptation, implementation, and evaluation of the educational programs were recommended [ 33 ].

Thus, patients should be trained for foot ulcer prevention based on clinical practice guidelines for diabetes mellitus both in the community and hospitals. The results of the current study encouraged a positive outlook: A diabetes educator should give necessary advices to patients during every visit, in order to improve their perception about disease, diet, and lifestyle changes and help them control their glycemic level and overcome the complications of diabetes.

According to the principle of “prevention is better than cure” and considering the predictive factors in the current study including poor knowledge, urban residency, being single, and lack of DFU, more attention should be paid to patients possessing risk factors .

Knowledge and practice toward foot care were poor in most patients with diabetes. There was a significant relationship between some demographic characteristics of patients and knowledge and practice toward foot care. The level of knowledge, place of residence, marital status, and history of hospital stay due to DFU were the predictors of practice in patients with diabetes.

The strength of the current study was that it was the first, study to discuss this important issue in Guilan Province. The study also had some limitations; first, since the work had a cross sectional design, the direction of relationships and causal relationships cannot be determined. Second, the result of the study should be interpreted with caution, since they were obtained from a single center; a clinic-based study. Hospital-based studies cannot provide a true picture of knowledge and practice in the community. The current study sample did not represent the whole Iranian population consisting of several ethnicities. In this research, responses of the wrong answers and “I don’t know” have been grouped together, in order to achieve better analysis. Perhaps with increasing sample size, we could solve this problem in future studies.

Adequate knowledge and good practices are important to effectively control diabetes mellitus. Patients require continuous support of family members and community in order to modify their lifestyle and behaviors and make sustainable changes in order to better control their diabetes disease. Also, education about diabetes mellitus and its risk factors should be provided through mass media in order to effectively control it in the community.

Availability of data and materials

The datasets used and /or analyzed during the current study are available from the corresponding author on reasonable request.

Abbreviations

Content validity index

Content validity ratio

Diabetic foot ulcers

Eastern Mediterranean Region

World health organization

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Acknowledgements

The authors wish to thank all the individuals who helped throughout the study, especially Razi Clinical Research Development Center.

The study was funded by the Deputy for Research; Guilan University of Medical Sciences. The funder had no role in the study design, data analysis and interpretation, and writing of the manuscript.

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Aydin Pourkazemi, Monireh Khojamli, Heydarali Balo, Hossein Hemmati & Zakiyeh Jafaryparvar

Social Determinants of Health Research center, nursing and midwifery school, Guilan University of medical sciences, Rasht, Iran

Atefeh Ghanbari

Department of internal medicine , Razi Hospital ,School of Medicine, Guilan university of Medical Sciences, Rasht, Iran

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PA, KM, and GA: the study design; PA,KM and MB: data collection; PA, KM, GA, HH, and BH: data analysis; PA, GA, KM, BH, HH, MB and JZ: data interpretation and drafting of the manuscript. All authors read and approved the final version of the manuscript.

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Pourkazemi, A., Ghanbari, A., Khojamli, M. et al. Diabetic foot care: knowledge and practice. BMC Endocr Disord 20 , 40 (2020). https://doi.org/10.1186/s12902-020-0512-y

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Research Article

Improving foot self-care in people with diabetes in Ghana: A development and feasibility randomised trial of a context appropriate, family-orientated diabetic footcare intervention

Contributed equally to this work with: Joseph Ngmenesegre Suglo, Kirsty Winkley, Jackie Sturt

Roles Conceptualization, Data curation, Formal analysis, Investigation, Methodology, Project administration, Writing – original draft

* E-mail: [email protected]

Affiliations Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King’s College London, London, United Kingdom, Department of Nursing and Midwifery, Presbyterian University, Agogo, Ghana

Roles Conceptualization, Investigation, Methodology, Resources, Supervision, Validation, Writing – review & editing

Affiliation Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King’s College London, London, United Kingdom

Joseph Ngmenesegre Suglo,
Kirsty Winkley,
Jackie Sturt

Published: May 8, 2024
https://doi.org/10.1371/journal.pone.0302385
Peer Review
Reader Comments

Africa presents a higher diabetic foot ulcer prevalence estimate of 7.2% against global figures of 6.3%. Engaging family members in self-care education interventions has been shown to be effective at preventing diabetes-related foot ulcers. This study culturally adapted and tested the feasibility and acceptability of an evidence-based footcare family intervention in Ghana.

The initial phase of the study involved stakeholder engagement, comprising Patient Public Involvement activities and interviews with key informant nurses and people with diabetes (N = 15). In the second phase, adults at risk of diabetes-related foot ulcers and nominated caregivers (N = 50 dyads) participated in an individually randomised feasibility trial of the adapted intervention (N = 25) compared to usual care (N = 25). The study aimed to assess feasibility outcomes and to identify efficacy signals on clinical outcomes at 12 weeks post randomisation. Patient reported outcomes were foot care behaviour, foot self-care efficacy, diabetes knowledge and caregiver diabetes distress.

Adjustments were made to the evidence-based intervention to reflect the literacy, information needs and preferences of stakeholders and to develop a context appropriate diabetic foot self-care intervention. A feasibility trial was then conducted which met all recruitment, retention, data quality and randomisation progression criteria. At 12 weeks post randomisation, efficacy signals favoured the intervention group on improved footcare behaviour, foot self-care efficacy, diabetes knowledge and reduced diabetes distress. Future implementation issues to consider include the staff resources needed to deliver the intervention, family members availability to attend in-person sessions and consideration of remote intervention delivery.

A contextual family-oriented foot self-care education intervention is feasible, acceptable, and may improve knowledge and self-care with the potential to decrease diabetes-related complications. The education intervention is a strategic approach to improving diabetes care and prevention of foot disease, especially in settings with limited diabetes care resources. Future research will investigate the possibility of remote delivery to better meet patient and staff needs.

Trial registration

Pan African Clinical Trials Registry (PACTR) ‐ PACTR202201708421484: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=19363 or pactr.samrc.ac.za/Search.aspx .

Citation: Suglo JN, Winkley K, Sturt J (2024) Improving foot self-care in people with diabetes in Ghana: A development and feasibility randomised trial of a context appropriate, family-orientated diabetic footcare intervention. PLoS ONE 19(5): e0302385. https://doi.org/10.1371/journal.pone.0302385

Editor: Sascha Köpke, University Hospital Cologne: Uniklinik Koln, GERMANY

Received: October 12, 2023; Accepted: March 29, 2024; Published: May 8, 2024

Copyright: © 2024 Suglo et al. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Data Availability: All relevant data are within the manuscript and its Supporting Information files.

Funding: This study is a part of JNS PhD thesis at King's College London funded by the Centre for Doctoral Studies under the Africa International Postgraduate Research Scholarship. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. No grant numbers applicable to scholarship received by JNS.

Competing interests: The authors have declared that no competing interests exist.

Introduction

Diabetes is a public health challenge, with a global estimate of 578 million and 700 million people with the disease by 2030 and 2045, respectively [ 1 ]. The most common and expensive complications to treat are diabetic foot ulcers (DFU) [ 2 , 3 ]. People with diabetes have approximately a 25% risk of developing open wounds and neuropathies in their lifetime [ 4 ]. This has made DFU the leading cause of non-traumatic amputations [ 5 ], with morbidity and mortality related to DFU at almost 50% over a five-year period [ 6 ]. This puts economic pressure and stress on health care systems, especially in low-middle-income countries (LMIC) with a higher DFU burden than the global prevalence estimates of 6.3% [ 7 ].

High-income countries have significantly reduced DFU burden over the past two decades through patient education, specialist care, clear referral pathways, and multidisciplinary or professional teams [ 8 – 10 ]. These measures are affirmed by international guidance [ 11 , 12 ]. Current research suggests that family members and friends can significantly influence an individual’s ability to manage DFU at home [ 13 – 16 ]. Therefore, the engagement of families in diabetes self-management programs may enable families to fulfil a vital role in diabetes care and prevention [ 17 , 18 ].

In populations with strong family ties, interventions that engage both the person with diabetes and family caregivers can enhance self-care behaviours related to medication, diet, coping and problem-solving skills [ 13 , 19 – 21 ]. In Asia, the Americas and Indonesia, caregivers’ involvement in foot inspection, checking of feet sensation, diet/meal planning, and setting of diabetes self-management goals resulted in better diabetes outcomes [ 21 ]. Similarly, in most African countries, there is strong kinship and ties with family members who often provide physical, mental, and economic support to people with chronic conditions [ 22 – 24 ].

In Ghana, complications related to diabetes are one of the top ten causes of medically related deaths [ 25 , 26 ]. Despite local efforts in diabetes care, patients and their social networks lack knowledge of evidence-based approaches to prevent or manage the condition [ 27 ]. Nonetheless, families and friends in Ghana view caring for an unwell relative as a communal and moral responsibility [ 22 ]. Indeed, increasing family engagement is being explored as an innovative strategy to advance the agenda of the Ministry of Health Ghana (MOH) of enhancing care for people with diabetes and other non-communicable diseases [ 28 ].

Given this, there is an imperative to contextualise and evaluate the effectiveness of family-based interventions for the prevention of DFUs in Ghana. A previous systematic review [ 21 ] identified a candidate programme for a family-orientated diabetic footcare intervention that might be suitable for delivery in Ghana. The intervention, which had previously been delivered in a LMIC but not evaluated anywhere in Africa, offered self- and family management education and skills training. It demonstrated significant improvement in foot care behaviours, diabetes knowledge, wound healing and DFU incidence [ 29 , 30 ]. This study therefore aimed to:

Culturally adapt a family-oriented diabetic foot self-care intervention for families in Ghana informed by stakeholder views.
Explore the acceptability of the adapted intervention with people at high risk of DFU and their families.
Determine the feasibility of conducting a randomised trial to evaluate the effectiveness of the intervention.

Materials and methods

The study comprised two phases (1 and 2):

Phase 1 Intervention development/Adaptation.

The ADAPT guidance for culturally adapting complex interventions to new contexts informed the process [ 31 ]. In consultation with the diabetes clinical research lead for the study, we approached people with diabetes, carers, and healthcare professionals in Ghana to join a patient public involvement (PPI) group. This group helped to facilitate the adaptation of an evidence-based intervention identified from our earlier systematic review [ 21 ]. The PPI group also provided their opinions on the suitability of the intervention and areas that needed modification. The evidence-based intervention was a “3-month self- and family management support program” which provided participant education on diabetes, diabetic foot and/or wound care skills and encouraged family involvement in diabetic foot ulcer care. Details of all components of this intervention have been published elsewhere [ 21 , 32 ].

Key informants (comprising nurses, people with diabetes, and family caregivers) were then recruited with ethical approval and interviewed to provide further feedback on the intervention with regards to content, delivery, relevance and acceptability. The original diabetic footcare (DFC) intervention was delivered by the researcher (JNS) to key informants, face-to-face in a group setting, before semi-structured interviews commenced. A copy of the interview schedule can be found in S4 File . All key informants were interviewed individually, and all interviews lasted between 35 to 45 minutes. At the conclusion of this phase, the development of the adapted DFC intervention was completed.

Upon the researcher’s request, three key informant nurses from phase 1 volunteered to deliver the intervention in phase 2 to patients and their families. All three nurse providers had at least a Bachelor of Science degree in nursing and received an additional four hours of facilitation training provided by the researcher (JNS) before delivering the intervention,

Phase 2: Feasibility trial

A two-arm feasibility randomised trial, with participants equally randomised to either a control or an intervention arm, was conducted to determine the acceptability of the intervention and the feasibility of conducting a future effectiveness evaluation. Standard care at the clinic comprised regular appointments with a physician and monitoring of blood pressure, weight and blood glucose. Participants in the control group and intervention group received this care as usual. In addition, the intervention group also received the experimental family-oriented intervention.

Family-orientated foot care intervention.

This was a 2-hour weekly program delivered over four weeks in groups, face-to-face, by trained nurses. The program incorporated education on diabetes and experiential skills workshops on foot checks and self-care. Thematic areas of the program comprised: diabetes and its complications; individual risk factors, diabetes-related foot problems; family roles in diabetic foot ulcer prevention; foot checks/care; foot hygiene; footwear and socks selection; and foot sensitivity checking and physical activity. It also involved providing participants in the intervention group with (i) nail clippers to support training on the proper cutting of toenails (ii) a plastic handy mirror for inspection of the bottom of their feet, (iii) a 10g monofilament for an experiential demonstration on foot sensitivity checking (iv) a bag to contain all equipment. Following self-management education, skills demonstration by the nurse and a return demonstration of foot care by people with diabetes and caregivers, each participant, assisted by their caregiver, was asked to perform daily foot care at home. Full details of the intervention curriculum are presented as a ( S5 File ).

Phase 1 and 2 participants and sample size

Study participants in both phases 1 and 2 were people with diabetes and their respective family caregivers who were recruited as a dyad. Professionals (nurses) also participated in phase 1. Consideration was given to the availability and willingness of people with diabetes, carers and healthcare providers [ 31 , 33 ]. Thus, through a purposive sampling technique, 5 family-dyads and 5 nurses were recruited in phase 1 as key informants to guide the development of the intervention.

Feasibility trials do not need a power-based sample size calculation, although a sample with at least 25 dyads per trial arm is deemed a good practice [ 34 – 36 ]. For the purposes of providing a standard deviation (SD) that facilitates a sample size calculation for a future trial, Julious [ 37 ] proposes the recruitment of at least n = 12 per group. This is equivalent to N = 24 for a traditional two arm trial which is also similar to sample sizes proposed by other authors [ 38 ]. It has been suggested that sample sizes that are less than 70–100 per group will produce large confidence intervals, and if examining the confidence intervals of feasibility process outcomes, then a sample size of at least 70 is recommended [ 39 ]. However, these feasibility sample size recommendations should also be based on pragmatic considerations including resource and budgetary constraints. A recent pilot trial of a different intervention in a similar population of people with diabetes in Ghana recruited 26 participants per trial arm for an effect size of 0.8, at a power of 80%, and an alpha level of 5% [ 40 ]. In phase 2, fifty dyads were recruited into this feasibility trial. Participants for both phase 1 as key informants and the phase 2 feasibility trial met the eligibility criteria described in Table 1 .

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Recruitment and consent process

Recruitment was conducted by the researcher (JNS) and a trained research nurse. All recruitment activities were conducted between February 15 and 30 August 2022 at the diabetes clinic of Konfo Anokye Teaching Hospital (KATH). The diabetes clinic is part of a bigger 1200-bed capacity tertiary hospital centrally located in Kumasi, the administrative capital of the Ashanti region of Ghana. The central location and good skill mix of healthcare professionals means that the clinic receives referred patients from most parts of the country.

Potential participants were invited to the study through information posters displayed on key notice boards within the diabetes clinic. The posters were titled “Diabetic footcare education and training in Ghana” and provided the researcher’s contact details. Some of these posters were also displayed on key staff areas such as the consulting physicians’ table and the nurses’ assessment table. A trained research nurse for this study also made a daily verbal announcement every morning before the start of patient consultations when all service users usually arrive and wait for a clinic consultation. Potential participants upon hearing the announcements or seeing the study poster could contact the researcher directly by phone, email or face-to-face. The researcher (JNS) or a trained research nurse was present at the clinic on a daily basis to manage recruitment. People with diabetes and family caregivers were recruited together but asked to contact the researcher separately to express interest and confirm participation. Potential participants were given the information sheet and screened for eligibility by the researcher (JNS).

Eligible participants voluntarily provided individual written informed consent either at the recruitment centre or completed the consent form at home and returned it to the researcher through a delivery service at the researcher’s cost. The trial was pre-registered with the Pan African Clinical Trial Registry (PACTR202201708421484) and ethical permission was granted by King’s College London (HR/DP-21/22-26606) and the KATH Institutional Review Board (IRB/AP/139/21).

Randomisation and blinding

Upon signing the informed consent, participants completed their baseline assessments and measures before randomisation. Randomisation was done at the individual level. Eligible dyad participants were randomly assigned in a 1:1 ratio using a remote computer-generated random number sequence by an independent statistician who was not part of the research team. The independent statistician generated the randomisation sequence prior to the start of all recruitment activities and had no patient contact. A trial coordinator, blinded until this point, accessed the randomisation database and assigned participating dyads to the intervention and control groups. Due to the physical nature of the intervention, participants, the researcher supervising intervention delivery, and providers delivering the intervention were not blinded to allocation groups. However, the outcomes assessor collecting follow up data from patients was unaware of their assigned group. Also, healthcare workers who provided usual care at the diabetes clinic were blind to the assigned groups of participants. Following allocation, participants were advised not to disclose their group to the staff at the diabetes clinic.

Phase 2 outcomes

Outcomes included feasibility criteria and patient reported outcome measures (PROMS) which were taken at baseline before randomisation and 12 weeks post randomisation. Thus, all baseline data were collected during the period of recruitment (February to August 2022) and follow up data from 1 st to 20 th December 2022.

Feasibility measures.

Based on existing evidence from previous studies of self-care interventions, [ 40 ] feasibility progressing criteria to a definitive RCT were predefined by the research team. Feasibility measures comprised: 1) evaluations of recruitment; 2) data completion; 3) intervention session attendance; and 4) participant retention. Recruitment rate was calculated as the number who consented to enter the study over the number who were screened as eligible. Research retention rate referred to the proportion of these participants who were available for data collection at 12 weeks follow-up. Similarly, data completion was defined as the percentage of returned and complete questionnaires at 12 weeks. An additional measure included after the study had started was to determine the proportion of people expressing interest in the study who were eventually eligible. This was to identify whether we were able to include majority of interested persons and if not why.

PROMS : Patient reported outcomes were collected to assess the feasibility of obtaining relevant measures for a full-scale trial. A nurse who was not part of the research team collected questionnaires and demographic data from each participant at the 12-week follow-up.

Foot care behaviour was assessed using the adapted Nottingham Assessment of Functional Footcare (NAFF) measure [ 41 ]. NAFF has indicated internal consistency (Cronbach’s alpha = 0.61) and good test-retest reliability (r = 0.91, p < 0.001). The 26-item scale was adapted by the study stakeholders, deleting nine questions with items such as “do you use hot water bottles in bed?” which were not considered relevant for people living in high temperature climates. Each NAFF item is scored from 0 to 3 according to the frequency of a practice, and then summed to produce an overall score, with scores ˃ 50 suggesting satisfactory or good foot care behaviour [ 42 ].
Foot self-care efficacy was assessed using the Foot Care Confidence Scale (FCCS) [ 43 ] which has good internal consistency (Cronbach’s alpha = 0.92) and has good content validity as confirmed by diabetes educators. Although re-test reliability has not been reported, all twelve scale items loaded on one factor in a factor analysis, suggesting that all items are required to adequately measure foot self-care efficacy [ 43 ]. Each item is scored on a scale of 1 (strongly lack confidence) to 5 (strongly confident). The maximum score for a participant is 60, and the higher the score the more confident the individual feels in the performance of the recommended footcare.
The Diabetes Knowledge Questionnaire (DKQ-24) [ 44 ] was used to assess the diabetic foot knowledge of both participants with diabetes and their family caregivers. The 24-item questionnaire was validated among people with diabetes and their support people in the US and demonstrated good construct validity and internal consistency (Cronbach’s alpha = 0.78). Each item has three response options consisting of: 1) “Yes”; 2) “No”; and 3) “I don’t know.” Items are checked against answers, and then scored as correct (1) or incorrect (0) with “I don’t know” scored as incorrect. The correct items are then summed to attain a total score. A higher score indicates a better knowledge of diabetes.
Finally, the Diabetes Distress Scale for Spouses and Partners (DDS-SP) [ 45 ] was used to assess the level of distress caregivers had related to their relatives’ diabetes. Although there is no reported re-test reliability value, the instrument has demonstrated good internal consistency (Cronbach’s alpha = 0.95). The 22-item instrument is scored on a scale of 0 to 4, with 0 indicating no distress at all and 4 representing a great deal of distress. A higher score indicates the presence of a greater level of diabetes-related distress. A meaningful cut-off point of two indicates moderate stress, and is equivalent to feeling, on average, ‘‘a little” distressed or greater [ 45 ].

Data analysis

Phase 1 analysis of interviews..

Data from the individual interviews were audio recorded and transcribed verbatim. A thematic content analysis [ 46 ] was used to analyse participants’ responses. Firstly, the lead researcher (JNS) familiarised themselves with the data by reading the transcript repeatedly. Then they developed codes which were checked by other team members (JS and KW). Codes with similar meanings were grouped to form categories.

A priority of the analysis was to identify contextual challenges to implementing the intervention, and thus the analysis was supported by the Consolidated Framework for Implementation Research (CFIR) [ 47 ]. This consists of five key domains (intervention characteristics, inner setting, outer setting, characteristics of individuals, and process) which affect implementation. The use of CFIR was not to guide the generation of codes but instead to infer how codes related to its constructs. Thus, CFIR was used to identify possible enablers and barriers to a future intervention study.

An evidence matrix was developed, combining empirical findings from the interviews with insights from an earlier systematic review [ 21 ] on DFU interventions. Using these two sources of data assisted with understanding any conflicting perspectives emerging within the interview data. It also supported decision making on content, duration and delivery of the final adapted intervention.

Phase 2 feasibility study analysis.

Data was analysed using Statistical Package for Social Sciences (SPSS) version 22. Participants characteristics, recruitment, retention, intervention session attendance and data completion rates were analysed using descriptive statistics, frequencies and percentages as appropriate to answer the predefined trial feasibility criteria (See Table 2 . for criteria). An additional analysis of the percentage of people expressing interest in the study who were determined to be eligible was computed.

https://doi.org/10.1371/journal.pone.0302385.t002

Statistical analysis plan.

Despite the trial not being designed or powered to show an effect of the intervention, all patient reported outcomes, means and standard deviations were still computed. The mean differences between groups at follow-up were compared using independent sample t tests, and included only participants who completed the treatment originally allocated. Normality of the data was assessed through a visual inspection of histograms, aiming to identify bell-shaped distributions which are characteristic of a normal distribution. This method allowed for the qualitative evaluation of the distributional properties of the variables under consideration. The t-test was performed as a one-sided statistical test with a significance level set at α = 0.05. Our desired effect size was 0.8, which corresponds to a large effect according to Cohen’s conventions [ 48 ]. The analysis of PROMS was conducted to provide only broad efficacy signals of the intervention that might be found in a future effectiveness trial, rather than to determine a definitive result in this feasibility trial. Thus, p-values are not presented, as the study was not powered to estimate the effect of the intervention. An available-case analysis (Pairwise deletion) approach was utilised to manage missing data. By this mechanism, we maximised all available data for each specific analysis [ 49 ]. Thus, if an observation had missing values for certain variables, it was excluded from analyses involving those particular variables, but was still included other analyses where it had complete data.

Phase 1 interviews

Fifteen key informants comprising family dyads (n = 5), caregivers (n = 5) and nurses (n = 5) took part in the interviews. Categories emerging from the interviews with nurses, people with diabetes and families are provided in Tables 3 and 4 . alongside supporting quotations.

https://doi.org/10.1371/journal.pone.0302385.t003

https://doi.org/10.1371/journal.pone.0302385.t004

Whilst people with diabetes and their families were generally positive with regards to the intervention’s look, content and practical educational approaches (including skills demonstrations) there was less consensus regarding the length of the intervention and the optimal method of delivery (remote versus face-to-face).

The five nurses felt that the intervention was very relevant to people with diabetes, and that it was important to support family members who were caring for aged patients. A positive facilitator to implementation was that nurses, especially those who were not specialists, believed that delivering the intervention increased their abilities and skills to teach good footcare to their clients. Some nurses reported feeling confident with supervision from their line manager when beginning intervention delivery. They also reported that as their confidence grew, they would be more comfortable providing the education as part of their practice. However, they identified barriers to implementation, with the most prominent being their lack of time to provide the longer sessions required to demonstrate footcare skills to patients. They also felt that the requirement to teach people with diabetes and caregivers in scheduled face-to-face sessions could be problematic given that so many family members work. They suggested that while the intervention held great promise and needed to be promoted, there were also some potential implementation barriers to realising its full potential. Table 4 . presents details of inferred facilitators and barriers to the intervention.

Final intervention adaptation.

The intervention incorporated diabetes education and an experiential skills workshop on foot checks and care at home. Specific content included: diabetes and its complications; diabetes-related foot problems; self-and family management of diabetes; family roles in DFU prevention; foot checks/care; foot hygiene; footwear and socks selection; foot sensitivity checking and physical activity. Whilst participants were divided in their views regarding the optimal mode of intervention delivery (face-to-face or remote), all effective interventions of a similar nature identified in an earlier systematic review [ 21 ] had been delivered face-to-face. It was also not possible to develop the intervention further for remote delivery before the Phase 2 feasibility trial due to pragmatic reasons and resource implications. Thus, the final intervention was delivered face-to-face in groups at the diabetes clinic. Details of the adaptations made to the original candidate intervention as a result of phase 1 of the study can be found in Table 5 .

https://doi.org/10.1371/journal.pone.0302385.t005

Phase 2 Feasibility trial results

From February to August 2022, 434 people with diabetes expressed interest in the study and were assessed for eligibility. Out of those assessed, 83 met the inclusion criteria resulting in 83 potential dyads. Fifty of these dyads consented and were randomised. The reasons for study ineligibility and loss to follow up are provided in the CONSORT diagram ( Fig 1 ).

https://doi.org/10.1371/journal.pone.0302385.g001

The majority of the randomised participants were female with few differences in characteristics between the intervention and usual care groups. In comparison with participants with diabetes, caregivers were younger in age, with a mean age of 44.60 (SD 15.17) and 43.12 (SD 14.15) for the intervention and control groups respectively. Although the majority of the participants in the intervention group were married, most caregivers 27(54%) were sons/daughters caring for their parents rather than spouses. Demographic details for participants with diabetes and caregivers are presented in Table 6 .

https://doi.org/10.1371/journal.pone.0302385.t006

Feasibility outcomes.

All predetermined progression criteria relating to participant recruitment, retention, data completion and attendance were met (see Table 7 ). Two blood relatives with diabetes were randomised into different groups and there was some sharing of intervention materials between participants resulting in contamination. When determining the feasibility of a trial, it has been recommended that multiple sources of information should be considered and no single feasibility outcome should be considered in isolation [ 50 ]. We also computed the proportion of people expressing an interest in the study and who were eligible to participate and reported it as new criterion. In fact, there were a large number of patients who were interested in participating but deemed ineligible for the trial. This was for multiple reasons but in 60% of cases this was because of the requirement that family members also had to be available to take part in the study.

https://doi.org/10.1371/journal.pone.0302385.t007

Patient reported outcomes.

People with diabetes : At 12 weeks post-randomisation, participants remaining in the intervention group (n = 19) and control (n = 21) were each analysed in the group they were originally allocated. A between group analysis of NAFF, FCCS and DKQ-24 using independent samples t-tests, all showed that the direction of change favoured the diabetes education program with mean differences of 10.16 on the NAFF (95% C.I. 7.66, 12.67), 8.27 on the FCCS (95% C.I. 5.87, 10.68) and 1.44 on the DKQ-24 (95% C.I. 0.78, 2.09). Although none of the outcome measures provided a minimal clinically important difference, a higher score on each instrument was an indication of improved outcome.

Family caregivers : Participants retained in the intervention (n = 18) and control (n = 19) were analysed in their original groups. At follow up, between groups analysis indicated that caregivers in the intervention group had a greater increase in knowledge with a mean difference of 1.34 on the DKQ-24 (95% C.I. 0.84, 1.83) and less diabetes distress with a difference of -12.59 on the DDS-SP (95% C.I. -16.91, -8.27) respectively.

Discussion and conclusion

The findings from this study suggest that an adapted family orientated DFC intervention was acceptable to people with diabetes in Ghana and their families. Involving stakeholders in the development of healthcare interventions aids successful implementation and can increase patient uptake [ 51 – 53 ]. Engaging with stakeholders from the outset in this study, through PPI and key informants, promoted anchoring and acceptance among both providers and recipients of the DFC intervention. For example, the stakeholder consultation process identified low levels of literacy among participants which led to the development of easier to read text, greater use of foot hygiene images and an emphasis on skills demonstration to support effective learning.

Nurse informants were positive about the purpose and content of the intervention. People with diabetes and their families remained divided on whether face-to-face or remote delivery of the program would be more desirable. Remote or hybrid delivery might be useful to address factors such as urbanisation, migration and job commitments which mean that family members are not always available for face-to-face sessions [ 54 ]. Interventions should take advantage of the fast-growing technological advancement in LMIC [ 55 ]. A written manual of the intervention with illustrative images may be a useful adjunct to the programme. In addition, videos of the skills demonstration could be circulated via WhatsApp (Meta Platforms) [ 56 ] which is popular locally and features content encryption. The WhatsApp platform has been used successfully for facilitated discussions on remote consulting in primary healthcare in a similar African setting [ 57 ]. Such an approach would ensure that the adaptation of the intervention does not create the health inequalities that digital resources can sometimes cause [ 31 ]. Also, a pre-recorded video demonstration of the intervention may boost capacity by saving time for clinic staff who were concerned that understaffing and significant workloads would prohibit effective intervention delivery.

Favourable intervention effects were detected in improving knowledge, footcare behaviour, self-care efficacy and reducing caregiver diabetes distress. Given the feasibility stage of the research and small sample size, p-values were not reported, but the mean difference between groups at follow-up suggest greater improvements in the intervention group. The effect signals have wide confidence intervals due to the small sample size and should be interpreted with caution. However, these indications align with findings on the impact of family interventions for stroke survivors and caregivers [ 58 , 59 ], cancer patients [ 60 , 61 ] and other chronic diseases care [ 62 – 64 ]. They are also supported by previous studies which suggest that family/caregivers provide psychological support, reminders, meal planning and other significant roles that promote people’s self-management of their diabetes [ 13 , 65 – 68 ]. Family engagement has also been shown to reduce the stress associated with caregiving [ 69 ]. In addition, nurses reported how the intervention had increased their confidence and ability to support families regarding their foot-care.

Finally, the study confirmed that it is feasible to conduct an effectiveness trial, based on the trial protocol developed, to improve diabetic foot outcomes for people in Ghana. The study met all stipulated progression criteria. However, the protocol can be strengthened in a number of ways. For example, recruitment rates could be increased by allowing people with diabetes who do not attend clinic with their caregiver to participate, with information cascaded to the family by phone, video or through written information. In addition, significant enthusiasm about the program from the outset led to concern regarding being randomised to the control group, with several interested participants declining to participate for this reason. An alternative study design that permits all participants to receive the intervention at different time points might prove to be more acceptable [ 70 ].

Whilst outcome measures in this trial were well completed and reflected expected changes, none were developed and validated within the context of sub-Sahara Africa. Thus, it will be important to ensure their cultural relevance before further trial use. It was not possible to include objective clinical outcomes in this feasibility study. Given the incidence of foot ulcers and amputations in this population, a follow-up of at least 6 to 12 months would have been needed to observe any meaningful changes [ 71 , 72 ]. However, a future effectiveness trial with a longer follow-up duration may be able to assess outcomes such as ulcer rates and wound healing to provide clear information on clinical benefits.

A DFC intervention engaging both family caregivers and people with diabetes in skills training and education is a pragmatic approach. The intervention may confer benefits in terms of better knowledge of foot care, improved self-efficacy and self-management, and a decrease in family distress. These changes are important as they may translate into reduced mortality and morbidity from complications for people with diabetes. Patient education is particularly important in developing countries where foot specialist services and other foot care resources are mostly either not available or not affordable to people with diabetes. Involving informal caregivers generally in the management of chronic conditions is known to be cost-effective and has long-lasting positive effects [ 73 , 74 ].

Cultures with strong family ties may benefit enormously from this family-oriented intervention. Indeed, policymakers could optimize their health expenditure by supporting the involvement of this unpaid caring work by upskilling family caregivers [ 21 ]. Recognizing the contextual intricacies and distinct requirements of individuals living with diabetes and their families is paramount. This entails assessing whether the emphasis leans towards "individual" or "family" values [ 75 ]. Essential to this understanding is the acknowledgment of the interdependence among family members and their perceptions of health and illness, which are pivotal for successful implementation of family-based interventions. Moreover, ethnic minorities in Western countries, particularly those of African and Asian descent, often exhibit strong familial bonds [ 76 ]. Conducting further research and evaluation of family-based diabetes care interventions within these communities could potentially yield significant health benefits.

Strengths and limitations

This feasibility study was conducted under the same strict conditions of a full-scale trial and remains the first in this sub-region which explores the potential effect and feasibility of family-oriented footcare programs. Although the study had a relatively small sample size and short-term follow-up, it was not intended to be adequately powered to make statistical inferences about effectiveness. Further work on cost-effectiveness will also need to be conducted to determine the feasibility of incorporating it as part of routine practice in Ghana.

Conclusions

The family-oriented education intervention may have the potential to enhance the footcare behaviour and practice efficacy of people with diabetes through family caregivers’ engagement. Findings from this feasibility study have resulted in several recommendations. These include:

The study team should explore the potential of adapting some or all of the intervention for remote delivery to fit the work schedules of patients and carers and lessen staff burden.
Employing designs such as a waiting list control or a stepped wedge cluster design [ 70 , 77 ] may be an appropriate way of increasing recruitment to the trial.
Consideration should be given to the optimal outcome measures for this study and also any adaptations necessary to ensure that measures are culturally appropriate and sufficiently sensitive for studies conducted in sub-Saharan Africa.

Supporting information

S1 file. consort checklist..

https://doi.org/10.1371/journal.pone.0302385.s001

S2 File. Study protocol.

https://doi.org/10.1371/journal.pone.0302385.s002

S3 File. Membership of the PPI group.

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S4 File. Individual interview guide.

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S5 File. Intervention curriculum.

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S6 File. Phase 1 Interviews coding framework.

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S7 File. SPSS Data set persons with diabetes.

https://doi.org/10.1371/journal.pone.0302385.s007

Acknowledgments

Thanks to Mrs Agnes Owusu, Dr Philemon Amooba, Dr Frank Botsi Micah, Miss Mavis Mallory Mwinbam, Mr Silas Sebire and the entire Nursing team at the diabetic clinic of Komfo Anokye Teaching Hospital for diverse forms of support during this study. Thanks to Dr Samantha Coster for support in editing and proofreading this paper.

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Assessing and Counseling a Patient Diagnosed with Diabetes Mellitus about Foot Care

First Online: 07 May 2024

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Shaima Lari 4 ,
Noora Al Blooshi 5 &
Shammah Al Memari 6

Areas to be focused on: History of diabetes and its complications, and diabetic foot care.

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Lari, S., Al Blooshi, N., Al Memari, S. (2024). Assessing and Counseling a Patient Diagnosed with Diabetes Mellitus about Foot Care. In: Lari, S., Al Memari, S., Al Marzooqi, D. (eds) Family Medicine OSCE: First Aid to Objective Structured Clinical Examination. Springer, Singapore. https://doi.org/10.1007/978-981-99-5530-5_98

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Hypothalamic Inflammation Improves Through Bariatric Surgery, and Hypothalamic Volume Predicts Short-Term Weight Loss Response in Adults With or Without Type 2 Diabetes

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Adriana Pané , Laura Videla , Àngels Calvet , Judith Viaplana , Lídia Vaqué-Alcázar , Ainitze Ibarzabal , Mateus Rozalem-Aranha , Jordi Pegueroles , Violeta Moize , Josep Vidal , Emilio Ortega , Isabel Barroeta , Valle Camacho , Gemma Chiva-Blanch , Juan Fortea , Amanda Jiménez; Hypothalamic Inflammation Improves Through Bariatric Surgery, and Hypothalamic Volume Predicts Short-Term Weight Loss Response in Adults With or Without Type 2 Diabetes. Diabetes Care 2024; dc232213. https://doi.org/10.2337/dc23-2213

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Preclinical research implicates hypothalamic inflammation (HI) in obesity and type 2 diabetes pathophysiology. However, their pathophysiological relevance and potential reversibility need to be better defined. We sought to evaluate the effect of bariatric surgery (BS) on radiological biomarkers of HI and the association between the severity of such radiological alterations and post-BS weight loss (WL) trajectories. The utility of cerebrospinal fluid large extracellular vesicles (CSF-lEVs) enriched for microglial and astrocyte markers in studying HI was also explored.

We included 72 individuals with obesity (20 with and 52 without type 2 diabetes) and 24 control individuals. Participants underwent lumbar puncture and 3-T MRI at baseline and 1-year post-BS. We assessed hypothalamic mean diffusivity (MD) (higher values indicate lesser microstructural integrity) and the volume of the whole and main hypothalamic subregions. CSF-lEVs enriched for glial and astrocyte markers were determined by flow cytometry.

Compared with control group, the obesity and type 2 diabetes groups showed a larger volume and higher MD in the hypothalamic tubular inferior region, the area encompassing the arcuate nucleus. These radiological alterations were positively associated with baseline anthropometric and metabolic measures and improved post-BS. A larger baseline tubular inferior hypothalamic volume was independently related to lesser WL 1 and 2 years after BS. CSF-lEVs did not differ among groups and were unrelated to WL trajectories.

These findings suggest HI improvement after BS and may support a role for HI in modulating the WL response to these interventions.

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This article contains supplementary material online at https://doi.org/10.2337/figshare.25627503 .

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BMC Endocrine Disorders

Improving foot self-care in people with diabetes in Ghana: A development and feasibility randomised trial of a context appropriate, family-orientated diabetic footcare intervention

Trial registration

Introduction

Materials and methods

Family-orientated foot care intervention.

Phase 1 and 2 participants and sample size

Recruitment and consent process

Randomisation and blinding

Phase 2 outcomes

Feasibility measures.

Data analysis

Phase 2 feasibility study analysis.

Statistical analysis plan.

Phase 1 interviews

Final intervention adaptation.

Phase 2 Feasibility trial results

Feasibility outcomes.

Patient reported outcomes.

Discussion and conclusion

Strengths and limitations

Conclusions

Supporting information

S2 File. Study protocol.

S3 File. Membership of the PPI group.

S4 File. Individual interview guide.

S5 File. Intervention curriculum.

S6 File. Phase 1 Interviews coding framework.

S7 File. SPSS Data set persons with diabetes.

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Assessing and Counseling a Patient Diagnosed with Diabetes Mellitus about Foot Care

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