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.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Foot care intervention delivered by community health worker (CHWs): A scoping review.

Variations of Community Health Workers (CHWs) interventions in diabetes self-management education (DSME) have been reviewed by many studies. In contrast, specific interventions regarding foot care intervention (FCI) are scarce and need to be explored further as one preventive measure to reduce diabetic foot problems in the community. This scoping review aimed to identify, and report nature of FCIs and the core components of FCIs delivered by CHWs. The scoping review was undertaken using PRISMA Extension for Scoping Reviews (PRISMA-ScR). The following electronic databases were searched for articles from data first indicated date through December 2022: CINAHL, EMBASE, Cochrane, Scopus, Web of Science, Theses ProQuest, PubMed, google scholar and other sources by using search terms related to foot care, community health workers, and diabetes mellitus. Descriptive synthesis was used to summarise the data. Nine studies from 1644 were included. All studies found that CHWs provided DSME in general, and foot care education was included. There was no detailed description of the core components of the intervention on foot care. Although, all studies might not provide detailed data on how CHW provided FCIs; the CHW intervention is an undoubtedly vital strategy to promote and prevent foot problems in medically underserved communities.

[Foot surgery for internal offloading in diabetic foot syndrome (DFS) - therapy and prevention]. / Chirurgische Therapieoptionen beim diabetischen Fußsyndrom.

Offloading for DFS must not mean immobilisation. The independence of those affected must not be significantly restricted by the treatment outside of emergency situations. Surgical options, which must be adapted to the degree of mobility of the affected person, can be helpful here. Entities are subgroups of DFS that are defined by their location. They provide easy access to the biomechanical causes of wounds, the prognosis and the surgical treatment concepts. There are often surgical alternatives to amputations and the fear of complications is not justified, as the main complication is usually the amputation itself. Neuropathy-related postoperative treatment cancellations during ulcer offloading must be safely ruled out.

Cost-effectiveness of temperature monitoring to help prevent foot ulcer recurrence in people with diabetes: A multicenter randomized controlled trial.

AIMS: Diabetes-related foot ulcers are common, costly, and frequently recur. Multiple interventions help prevent these ulcers. However, none of these have been prospectively investigated for cost-effectiveness. Our aim was to evaluate the cost-effectiveness of at-home skin temperature monitoring to help prevent diabetes-related foot ulcer recurrence. MATERIALS AND METHODS: Multicenter randomized controlled trial. We randomized 304 persons at high diabetes-related foot ulcer risk to either usual foot care plus daily at-home foot skin temperature monitoring (intervention) or usual care alone (control). Primary outcome was cost-effectiveness based on foot care costs and quality-adjusted life years (QALY) during 18 months follow-up. Foot care costs included costs for ulcer prevention (e.g., footwear, podiatry) and for ulcer treatment when required (e.g., consultation, hospitalisation, amputation). Incremental cost-effectiveness ratios were calculated for intervention versus usual care using probabilistic sensitivity analysis for willingness-to-pay/accept levels up to €100,000. RESULTS: The intervention had a 45% probability of being cost-effective at a willingness-to-accept of €50,000 per QALY lost. This resulted from (non-significantly) lower foot care costs in the intervention group (€6067 vs. €7376; p = 0.45) because of (significantly) fewer participants with ulcer recurrence(s) in 18 months (36% vs. 47%; p = 0.045); however, QALYs were (non-significantly) lower in the intervention group (1.09 vs. 1.12; p = 0.35), especially in those without foot ulcer recurrence (1.09 vs. 1.17; p = 0.10). CONCLUSIONS: At-home skin temperature monitoring for diabetes-related foot ulcer prevention compared with usual care is at best equally cost-effective. The intervention resulted in cost-savings due to preventing foot ulcer recurrence and related costs, but this came at the expense of QALY loss, potentially from self-monitoring burdens.

Exploring the Pathways of Diabetes Foot Complications Treatment and Investigating Experiences From Frontline Health Care Professionals: Protocol for a Mixed Methods Study.

BACKGROUND: Diabetes affects more than 4.3 million individuals in the United Kingdom, with 19% to 34% developing diabetes-related foot ulceration (DFU) during their lifespan, which can lead to an amputation. In the United Kingdom, every week, approximately 169 people have an amputation due to diabetes. Preventing first-ever ulcers is the most effective strategy to reduce the occurrence of diabetes-related amputations, but research in this space is lacking. OBJECTIVE: This protocol seeks to document the experiences and perspectives of frontline health care professionals who work with people who have diabetes and diabetes-related foot problems. Special attention is given to their perceptions of barriers to effective care, their views about barriers to effective and inclusive engagement with people with diabetes, and their experience with the first-ever DFU. Another aspect of the study is the focus on whether clinical management is affected by data sharing, data availability, and interoperability issues. METHODS: This is a mixed methods explanatory protocol, which is sequential, and its purpose is to use the qualitative data to explain the initial quantitative data collected through a survey of frontline health care professionals. Data analysis of quantitative data will be completed first and then synthesized with the qualitative data analysis. Qualitative data will be analyzed using the framework method. This study will use joint displays to integrate the data. Ethical approval has been granted by the ethics committee of Staffordshire University. RESULTS: The quantitative data collection started in March 2023 and will close in May 2024. The qualitative interviews commenced in November 2023 with volunteer participants who initially completed the survey. CONCLUSIONS: This study's survey focuses on data interoperability and the interviews focus more on the perspectives and experiences of clinicians and their perceived barriers for the effective management of diabetes foot ulcers. Including a geographically relevant and diverse cohort of health care professionals that spans a wide range of roles and care settings involved in diabetes-related foot care is very important for the successful application of this protocol. Special care is given to advertise and promote participation as widely as possible. The qualitative part of this protocol is also limited to 30-40 interview participants, as it is not realistic to interview higher numbers, due to time and resource constraints. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/54852.

Podiatrist intervention could reduce the incidence of foot ulcers in patients with diabetes: a hospital survey in China.

OBJECTIVE: This study aimed to evaluate the effectiveness of podiatrists in preventing diabetic foot ulcers (DFUs) in China. METHOD: The study was a prospective investigation. A total of 300 patients were enrolled from May 2016 to May 2018 in Handan Central Hospital, China. All patients who participated in this study had been diagnosed with type 2 diabetes, according to the International Classification of Diseases (ICD-10). All participants underwent our survey, which included basic patient data and information about DFUs. The patients were followed for one year, during which time they received appropriate intervention from podiatrists, including lifestyle guidance, callus resection, tinea grinding and ingrown nail correction. At the end of the year all the patients were surveyed again. The data before and after the year were statistically compared. RESULTS: The results showed that the incidence of DFUs in patients with diabetes was significantly decreased after one year of intervention from podiatrists (20.7% versus 6.7%, p<0.001). Additionally, there was a negative correlation between the number of intervention visits and the number of DFU occurrences (Spearman correlation coefficient: -0.496, p<0.001). Furthermore, we found that 68 patients with a history of DFUs or amputation had an obviously reduced incidence of DFUs after intervention by a podiatrist (89.7% versus 27.9%, p<0.001). We also investigated other foot risk factors in all participants, such as limb neuropathy (76.3%), lower extremity vascular disease (65.7%) and foot paralysis (43.7%). CONCLUSION: The results of this study help in understanding the situation of patients with diabetes in China and to prove that standardised podiatrist intervention has an important role in inhibiting the occurrence and development of DFUs.

Patient perceptions of barriers to attending annual diabetes review and foot assessment in general practice: a qualitative study.

Introduction Regular diabetic foot checks, at least annually, are important for early identification of risk factors and prevention of ulceration and amputation. To ensure this, most general practices in Aotearoa New Zealand (NZ) offer free annual diabetes reviews (ADRs) which include a comprehensive foot evaluation. However, attendance rates at these ADRs are low. Aim To explore patients' perspectives on the barriers to attending ADRs and foot checks. Methods Semi-structured interviews with people with type 2 diabetes who were overdue their ADR (n = 13; 7 women, 6 Maori) from two urban practices were conducted. Interviews were audio recorded and transcribed verbatim and then analysed using an inductive thematic analysis approach. Results We identified three key themes demonstrating barriers to attendance: healthcare-associated factors (suboptimal clinician-patient relationship, not having a consistent general practitioner (GP)); patient-related factors (co-morbid health conditions, issues surrounding identity, and logistical issues); and systemic factors (COVID-19 pandemic, travel distance to the practice, unawareness of available foot care services). Participants' feedback focused on patient-centred approaches for improvements to service delivery, for example using online educational materials, and utilising culturally appropriate models of health including Te Whare Tapa Wha and Whanau Ora approach. Discussion We identified several barriers to attendance, some of which are potentially modifiable. Addressing modifiable barriers and incorporating suggestions made by participants may improve access to the ADR and reduce non-attendance. Further participatory action research could explore these insights in ways that facilitate tino rangatiratanga (self-determination) and palpable action.

The effect of seven-step educational strategy on knowledge of diabetic foot ulcer prevention, critical thinking and self-efficacy of nursing students: A randomized controlled trial.

BACKGROUND: Diabetic foot ulcer is a significant complication of diabetes that carries a high mortality risk and is associated with substantial financial costs. Choosing a suitable educational model for nursing students as future nurses is necessary to improve knowledge and manage issues related to caring for diabetic patients. OBJECTIVES: To determine the effect of education based on the 7E learning cycle model on the knowledge of diabetic foot ulcer prevention, critical thinking, and self-efficacy in nursing students. DESIGN: A single-blind, randomized controlled trial with a parallel group. SETTINGS: This study was conducted in a nursing school and hospitals covered by it in Iran. PARTICIPANTS: 98 students studying in the fourth semester of the Bachelor of Nursing course. METHODS: Students were divided into two distinct groups at random: an experimental group (class A, with 51 participants), and a control group (class B, with 47 participants). The participants of the experimental group were provided with an education based on the 7E learning cycle model, while the control group received conventional teaching method. Data collection methods included pre- and post-tests using research instruments (demographic questionnaire, Kaya Diabetic Foot Prevention Knowledge Questionnaire, Ricketts' Critical Thinking Disposition Questionnaire, and General Self-Efficacy Scale). The data were analyzed using descriptive statistics, non-parametric Mann-Whitney and Wilcoxon tests, parametric independent sample t-tests, ANCOVA, and paired sample t-tests. RESULTS: The difference in mean scores of diabetic foot ulcer prevention knowledge (Z = -6.232, p < 0.001), critical thinking (t (50) = -4.382, p < 0.001), and self-efficacy (Z = -4.427, p < 0.001) in the experimental group were statistically significant between the time interval before the intervention and one month after its completion. CONCLUSIONS: Compared to conventional method of teaching, education based on the 7E learning cycle model is a more effective method to improve nursing students' knowledge of diabetic foot ulcer prevention, critical thinking, and self-efficacy.

Complications of Percutaneous Tendo-Achilles Lengthening for Treatment and Prevention of Diabetic Foot Ulcers: A Systematic Review.

Percutaneous Achilles tendon lengthening is an effective surgical procedure to treat and prevent forefoot and midfoot ulcerations in patients with diabetes. Patients with diabetes are prone to plantar ulcerations due to a combination of factors, such as peripheral neuropathy, decreased tendon elasticity, peripheral vascular disease, and hyperglycemia. Complications such as re-ulceration and transfer lesion to the heel, associated with a calcaneal gait secondary to over-lengthening, are possible with percutaneous Achilles tendon lengthening. Although percutaneous Achilles tendon lengthening is well accepted, the overall incidence of complication has not been well described. A systematic review of the reported data was performed to determine the incidence of complication for percutaneous tendo-Achilles lengthening when used for the treatment and prevention of diabetic plantar ulcerations. Nine studies involving 490 percutaneous lengthening procedures met the inclusion criteria. The overall complication rate was 27.8% (8% with transfer heel ulcerations). Given the high rate of complications associated with a percutaneous Achilles tendon lengthening, careful patient selection and consideration of these risks should be considered prior to proceeding with this procedure. Additional prospective comparative analyses with standardization of surgical technique, degrees of lengthening achieved, and post-operative weightbearing and immobilization modalities are needed to decrease incidence of complication and achieve higher healing rates.

Implementing a contextually appropriate foot-ankle exercise programme in primary care for the prevention of modifiable risk factors for ulcers in people with diabetes: protocol for a hybrid type 2 study.

INTRODUCTION: Diabetes is a highly prevalent disease that negatively impacts people's health and quality of life. It can result in diabetic peripheral neuropathy (DPN) and foot complications, which in turn lead to ulcers and amputations. The international guidelines on diabetic foot included specific foot-ankle exercises as preventive strategy capable of modifying the risk factors for ulcers. Our aim is to test the effectiveness and to implement a contextually appropriate preventive intervention-a foot-ankle exercises programme alongside educational strategies-in a primary care setting to improve range of motion (ROM), strength, functionality of foot-ankle, and quality of life in people with diabetes. METHODS AND ANALYSIS: This is a hybrid type 2 implementation-effectiveness study organised in four phases, being undertaken in Limeira, São Paulo. Phase 1, preimplementation, aims to gather information about the contextual characteristics, barriers, and facilitators and to form the implementation team. In phase 2, the implementation team will structure the foot-ankle programme, adapting it to the context of primary healthcare, and develop the training for health professionals. In phase 3, effectiveness of the 12 week group-based intervention will be tested by a cluster randomised controlled trial. Primary care units (18 clusters) will be randomly allocated to a control or intervention group, with a total sample of 356 people. Primary outcomes will be DPN symptoms and ankle and first metatarsal phalangeal joint ROM. Reach, adoption, and implementation will be evaluated by Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. In phase 4, maintenance and expansion of the programme in the municipality will be assessed. ETHICS AND DISSEMINATION: This protocol and the informed consent to be signed by the participants were approved by the Ethics Committee of the School of Medicine of the University of São Paulo (CAAE:63457822.0.0000.0068, 29 November 2022). The project will generate and share data in a public repository. Results will be disseminated through peer-reviewed journals, conference proceedings, and electronic communications for health professionals. TRIAL REGISTRATION NUMBER: NCT05639478.

Non-pharmacological interventions to improve cardiovascular risk factors in people with diabetic foot disease: A systematic review and meta-analysis.

Cardiovascular disease (CVD) risk in those with diabetic foot disease is very high. Non-pharmacological interventions may improve this risk, though no previous evidence synthesis has been completed. This systematic review aimed to investigate the impact of non-pharmacological interventions on CVD risk factors in diabetic ulcer disease. Multiple databases and trials registers were searched from inception to December 6th 2023. We included reports of randomised controlled trials investigating the impact of non-pharmacological interventions on cardiovascular risk in those with type 1 or type 2 diabetes and current or previous diabetic foot disease. Twenty studies were included. Extracted data included: study design and setting; participant sociodemographic factors; and change in cardiovascular risk factors. Data were synthesised using random effects meta-analyses and narrative syntheses. Interventions included nutritional supplementation, collaborative care, hyperbaric oxygen therapy, patient education, nurse-led intervention, self-management, family support, relaxation and exercise, over a median duration of 12 weeks. Significant post-intervention changes were observed in fasting plasma glucose, serum insulin levels, insulin sensitivity and resistance, glycated haemoglobin, triglycerides, total cholesterol, low-density lipoprotein-cholesterol and C-reactive protein. No effects were detected in very low- or high-density lipoprotein-cholesterol or body mass index. Non-pharmacological interventions show promise in improving CVD risk in diabetic foot disease.

Telemedical Monitoring of Plantar Temperature in Diabetic Patients at Risk of Foot Ulcers.

BACKGROUND: The worldwide prevalence of diabetic foot ulcers (DFUs) among persons with diabetes is estimated at 6.3%, with an annual incidence of 9.1 to 26.1 million persons. The early detection of asymmetrical plantar temperature elevation, followed by reduction of weight-bearing on the affected foot, may be an effective mode of prevention. METHODS: Patients with diabetes and peripheral neuropathy (DFU risk groups 2/3) were monitored for plantar abnormalities with a telemedical system consisting of sole inserts with temperature sensors and photographic documentation. An open, prospective, randomized controlled trial was performed to determine whether this system prevented DFUs. The intervention and control groups were also trained in ulcer prevention and observed in follow-up at 6-month intervals for 24 months. RESULTS: 283 patients were recruited. In 85 137 observation days, DFUs arose in five patients in the control group (n = 143) and in no patient in the intervention group (n = 140). The primary outcome measure was the hazard ratio, which was calculated to be 0.015 (95% confidence interval [0; 19,717]; p = 0.25) after adjustment for age, sex, severity of neuropathy, and risk class. There were 239 alarms and 75 instructions to reduce weight-bearing on the foot. The subjects carried out the telemedical application on about 70% of the days of observation. Quality of life improved in both groups. CONCLUSION: The tele-health system used in this trial is practical and enables the early detection of morbidity. Likely explanations for the unexpectedly low ulceration rate in this trial (and, in turn, for the lack of statistical significance) include the availability of a training program and regular follow-up examinations to patients in both arms of the trial, along with lower mobility levels due to the COVID pandemic.

A new declaration for feet's sake: Halving the global diabetic foot disease burden from 2% to 1% with next generation care.

The 1989 Saint Vincent Declaration established a goal of halving global diabetes-related amputation rates. A generation later, this goal has been achieved for major but not minor amputations. However, diabetic foot disease (DFD) is not only a leading cause of global amputation but also of hospitalisation, poor quality of life (QoL) and disability burdens. In this paper, we review latest estimates on the global disease burden of DFD and the next generation care of DFD that could reduce this burden. We found DFD causes 2% of the global disease burden. This makes DFD the 13th largest of 350+ leading conditions causing the global disease burden, and much larger than dementia, breast cancer and type 1 diabetes. Neuropathy without ulcers and amputations makes up the largest portion of the global DFD burden yet receives the least DFD focus. Future care focussed on improving safe physical activity in people with DFD could considerably reduce the DFD burden, as this incorporates increasing physical fitness and QoL, while simultaneously decreasing ulceration and other risks. Charcot neuro-osteoarthropathy is more prevalent than previously thought. Most cases respond well to non-removable offloading devices, but surgical intervention may further reduce the considerable burden of these neuropathic fracture dislocations. Ischaemia is becoming more common and complex. Most cases respond well to revascularisation interventions, but novel revascularisation techniques, medical management and autologous cell therapies may hold the key to more cases responding in the future. We conclude that DFD causes a global disease burden larger than most conditions and existing guideline-based care and next generation treatments can reduce this burden. We suggest the World Health Organization and International Diabetes Federation declare a new goal: halving the global DFD burden from 2% to 1% within the next generation.

Current Status and Principles for the Treatment and Prevention of Diabetic Foot Ulcers in the Cardiovascular Patient Population: A Scientific Statement From the American Heart Association.

Despite the known higher risk of cardiovascular disease in individuals with type 2 diabetes, the pathophysiology and optimal management of diabetic foot ulcers (DFUs), a leading complication associated with diabetes, is complex and continues to evolve. Complications of type 2 diabetes, such as DFUs, are a major cause of morbidity and mortality and the leading cause of major lower extremity amputation in the United States. There has recently been a strong focus on the prevention and early treatment of DFUs, leading to the development of multidisciplinary diabetic wound and amputation prevention clinics across the country. Mounting evidence has shown that, despite these efforts, amputations associated with DFUs continue to increase. Furthermore, due to increasing patient complexity of management secondary to comorbid conditions, such as cardiovascular disease, the management of peripheral artery disease associated with DFUs has become increasingly difficult, and care delivery is often episodic and fragmented. Although structured, process-specific approaches exist at individual institutions for the management of DFUs in the cardiovascular patient population, there is insufficient awareness of these principles in the general medicine communities. Furthermore, there is growing interest in better understanding the mechanistic underpinnings of DFUs to better define personalized medicine to improve outcomes. The goals of this scientific statement are to provide salient background information on the complex pathogenesis and current management of DFUs in cardiovascular patients, to guide therapeutic and preventive strategies and future research directions, and to inform public policy makers on health disparities and other barriers to improving and advancing care in this expanding patient population.

The value of loss of protective pain sensation in predicting a first ulceration of the foot in people with diabetes.

AIM: To determine both the risk of first ever ulcer (FEU) and its time to onset in a population which had loss of protective sensation (LOPS) in the foot either with or without loss of protective pain (LOPP). METHODS: People with diabetes and LOPS without history of FEU presenting in a specialist clinic were included. LOPP was diagnosed by reduced vibration perception and pain perception by using a pinprick simulator. Participants were followed by routine foot checks, phone interview or by letter until the occurrence of a FEU, death or the end of observation period. Survival functions in LOPP strata were compared by log rank test. The hazard ratio (HR) of an FEU in people with compared to people without LOPP was estimated using Cox regression. Time to first ulcer was estimated using the framework of an accelerated failure time (AFT) model. RESULTS: One hundred and thirty participants were followed up for a median of 48.3 months. Pain perception was lost in 55.4%. Eighteen people with LOPP developed a FEU (25.0%) as opposed to six (10.3%) of those with no LOPP (p = 0.02). Age-sex-adjusted HR for FEU was 3.0 (p = 0.02) for people with compared to people without LOPP. Age-sex-adjusted time to FEU for people with LOPP was approximately half (p = 0.03) than people without LOPP. CONCLUSIONS: It is suggested that estimation of LOPP is included in routine practice because of its high predictive value for a FEU.

Prevention of foot ulcers in persons with diabetes at risk of ulceration: A systematic review and meta-analysis.

AIMS: Prevention of foot ulcers in persons with diabetes is important to help reduce the substantial burden on both individual and health resources. A comprehensive analysis of reported interventions is needed to better inform healthcare professionals about effective prevention. The aim of this systematic review and meta-analysis is to assess the effectiveness of interventions to prevent foot ulcers in persons with diabetes who are at risk thereof. MATERIALS AND METHODS: We searched the available scientific literature in PubMed, EMBASE, CINAHL, Cochrane databases and trial registries for original research studies on preventative interventions. Both controlled and non-controlled studies were eligible for selection. Two independent reviewers assessed risk of bias of controlled studies and extracted data. A meta-analysis (using Mantel-Haenszel's statistical method and random effect models) was done when >1 RCT was available that met our criteria. Evidence statements, including the certainty of evidence, were formulated according to GRADE. RESULTS: From the 19,349 records screened, 40 controlled studies (of which 33 were Randomised Controlled Trials [RCTs]) and 103 non-controlled studies were included. We found moderate certainty evidence that temperature monitoring (5 RCTs; risk ratio [RR]: 0.51; 95% CI: 0.31-0.84) and pressure-optimised therapeutic footwear or insoles (2 RCTs; RR: 0.62; 95% CI: 0.26-1.47) likely reduce the risk of plantar foot ulcer recurrence in people with diabetes at high risk. Further, we found low certainty evidence that structured education (5 RCTs; RR: 0.66; 95% CI: 0.37-1.19), therapeutic footwear (3 RCTs; RR: 0.53; 95% CI: 0.24-1.17), flexor tenotomy (1 RCT, 7 non-controlled studies, no meta-analysis), and integrated care (3 RCTs; RR: 0.78; 95% CI: 0.58-1.06) may reduce the risk of foot ulceration in people with diabetes at risk for foot ulceration. CONCLUSIONS: Various interventions for persons with diabetes at risk for foot ulceration with evidence of effectiveness are available, including temperature monitoring (pressure-optimised) therapeutic footwear, structured education, flexor tenotomy, and integrated foot care. With hardly any new intervention studies published in recent years, more effort to produce high-quality RCTs is urgently needed to further improve the evidence base. This is especially relevant for educational and psychological interventions, for integrated care approaches for persons at high risk of ulceration, and for interventions specifically targeting persons at low-to-moderate risk of ulceration.

Practical guidelines on the prevention and management of diabetes-related foot disease (IWGDF 2023 update).

Diabetes-related foot disease results in a major global burden for patients and the healthcare system. The International Working Group on the Diabetic Foot (IWGDF) has been producing evidence-based guidelines on the prevention and management of diabetes-related foot disease since 1999. In 2023, all IWGDF Guidelines have been updated based on systematic reviews of the literature and formulation of recommendations by multidisciplinary experts from all over the world. In addition, a new guideline on acute Charcot neuro-osteoarthropathy was created. In this document, the IWGDF Practical Guidelines, we describe the basic principles of prevention, classification and management of diabetes-related foot disease based on the seven IWGDF Guidelines. We also describe the organisational levels to successfully prevent and treat diabetes-related foot disease according to these principles and provide addenda to assist with foot screening. The information in these practical guidelines is aimed at the global community of healthcare professionals who are involved in the care of persons with diabetes. Many studies around the world support our belief that implementing these prevention and management principles is associated with a decrease in the frequency of diabetes-related lower-extremity amputations. The burden of foot disease and amputations is increasing at a rapid rate, and comparatively more so in middle to lower income countries. These guidelines also assist in defining standards of prevention and care in these countries. In conclusion, we hope that these updated practical guidelines continue to serve as a reference document to aid healthcare providers in reducing the global burden of diabetes-related foot disease.

Clinical and biomechanical effectiveness of foot-ankle exercise programs and weight-bearing activity in people with diabetes and neuropathy: A systematic review and meta-analysis.

BACKGROUND: Most interventions to prevent foot ulcers in people with diabetes do not seek to reverse the foot abnormalities that led to the ulcer. Foot-ankle exercise programs target these clinical and biomechanical factors, such as protective sensation and mechanical stress. Multiple RCTs exist investigating the effectiveness of such programs, but these have never been summarised in a systematic review and meta-analysis. METHODS: We searched the available scientific literature in PubMed, EMBASE, CINAHL, Cochrane databases and trial registries for original research studies on foot-ankle exercise programs for people with diabetes at risk of foot ulceration. Both controlled and non-controlled studies were eligible for selection. Two independent reviewers assessed the risk of bias of controlled studies and extracted data. Meta-analysis (using Mantel-Haenszel's statistical method and random effect models) was performed when >2 RCTs were available that met our criteria. Evidence statements, including the certainty of evidence, were formulated according to GRADE. RESULTS: We included a total of 29 studies, of which 16 were RCTs. A foot-ankle exercise programme of 8-12 weeks duration for people at risk of foot ulceration results in: (a) no increase or decrease risk of foot ulceration or pre-ulcerative lesion (Risk Ratio (RR): 0.56 (95% CI: 0.20-1.57)); (b) no increase or decrease risk of adverse events (RR: 1.04 (95% CI: 0.65-1.67)); (c) not increase or decrease barefoot peak plantar pressure during walking (Mean Difference (MD): -6.28 kPa (95% CI: -69.90-57.34)); (d) no increase or decrease health-related quality of life (no meta-analysis possible). Likely results in increases in ankle joint and first metatarsalphalangeal joint range of motion (MD: 1.49° (95% CI: -0.28-3.26)) may result in improvements in neuropathy signs and symptoms (MD: -1.42 (95% CI: -2.95-0.12)), may result in a small increase in daily steps in some people (MD: 131 steps (95% CI: -492-754)), and may not increase or decrease foot and ankle muscle strength and function (no meta-analysis was possible). CONCLUSIONS: In people at risk of foot ulceration, a foot-ankle exercise programme of 8-12 weeks duration may not prevent or cause diabetes-related foot ulceration. However, such a programme likely improves the ankle joint and first metatarsalphalangeal joint range of motion and neuropathy signs and symptoms. Further research is needed to strengthen the evidence base, and should also focus on the effects of specific components of foot-ankle exercise programs.

Guidelines on the prevention of foot ulcers in persons with diabetes (IWGDF 2023 update).

AIMS: This is the 2023 International Working Group on the Diabetic Foot guideline on the prevention of foot ulcers in persons with diabetes, which updates the 2019 guideline. This guideline is targeted at clinicians and other healthcare professionals. MATERIALS AND METHODS: We followed the Grading of Recommendations, Assessment, Development and Evaluations methodology to devise clinical questions and critically important outcomes in the PICO format, to conduct a systematic review of the medical-scientific literature including, where appropriate, meta-analyses, and to write recommendations and their rationale. The recommendations are based on the quality of evidence found in the systematic review, expert opinion where (sufficient) evidence was not available, and a weighing of the desirable and undesirable effects of an intervention, as well as patient preferences, costs, equity, feasibility and applicability. RESULTS: We recommend screening a person with diabetes at very low risk of foot ulceration annually for the loss of protective sensation and peripheral artery disease, and screening persons at higher risk at higher frequencies for additional risk factors. For preventing a foot ulcer, educate persons at-risk about appropriate foot self-care, educate not to walk without suitable foot protection, and treat any pre-ulcerative lesion on the foot. Educate moderate-to-high risk people with diabetes to wear properly fitting, accommodative, therapeutic footwear, and consider coaching them to monitor foot skin temperature. Prescribe therapeutic footwear that has a demonstrated plantar pressure relieving effect during walking, to help prevent plantar foot ulcer recurrence. Consider advising people at low-to-moderate risk to undertake a, preferably supervised, foot-ankle exercise programme to reduce ulcer risk factors, and consider communicating that a total increase in weight-bearing activity of 1000 steps/day is likely safe with regards to risk of ulceration. In people with non-rigid hammertoe with pre-ulcerative lesion, consider flexor tendon tenotomy. We suggest not to use a nerve decompression procedure to help prevent foot ulcers. Provide integrated foot care for moderate-to-high-risk people with diabetes to help prevent (recurrence of) ulceration. CONCLUSIONS: These recommendations should help healthcare professionals to provide better care for persons with diabetes at risk of foot ulceration, to increase the number of ulcer-free days and reduce the patient and healthcare burden of diabetes-related foot disease.

Standards for the development and methodology of the 2023 IWGDF guidelines.

AIMS: Diabetes-related foot disease is a major source of patient burden and societal costs. Investing in evidence-based international guidelines on diabetes-related foot disease is important to reduce this burden and costs, provided the guidelines are focused on outcomes important to key stakeholders and are evidence-based and properly implemented. MATERIALS AND METHODS: The International Working Group on the Diabetic Foot (IWGDF) has published and updated international guidelines since 1999. The 2023 updates were made using the Grading of Recommendations Assessment Development and Evaluation evidence-to-decision framework. This concerns formulating relevant clinical questions and important outcomes, conducting systematic reviews of the literature and meta-analyses where appropriate, completing summary of judgement tables, and writing recommendations that are specific, unambiguous and actionable, along with their transparent rationale. RESULTS: We herein describe the development of the 2023 IWGDF Guidelines on the prevention and management of diabetes-related foot disease, which consists of seven chapters, each prepared by a separate working group of international experts. These chapters provide guidelines related to diabetes-related foot disease on prevention; classification of diabetes-related foot ulcer, offloading, peripheral artery disease, infection, wound healing interventions, and active Charcot neuro-osteoarthropathy. Based on these seven guidelines, the IWGDF Editorial Board also produced a set of practical guidelines. Each guideline underwent extensive review by the members of the IWGDF Editorial Board as well as independent international experts in each field. CONCLUSIONS: We believe that the adoption and implementation of the 2023 IWGDF guidelines by healthcare providers, public health agencies, and policymakers will improve the prevention and management of diabetes-related foot disease, and subsequently reduce the worldwide patient and societal burden caused by this disease.