[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.

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.

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.

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.

Prioritizing the Prevention of Diabetic Foot Disease: We Each Have a Role to Play.

BACKGROUND: Individuals living with diabetes mellitus (DM) are at an increased risk for multiple serious health complications including diabetic foot disease (DFD). Daily, DFD contributes to increased morbidity, mortality, increased hospitalization, limb amputation, and reduced quality of life. Prevention of DFD is a foundational component of diabetes management. PURPOSE: The purpose of this study was to explore how individuals manage the care required to protect their feet from DM related foot complications. METHODS: This qualitative descriptive study utilized semi structured interviews to explore the perspectives of 23 participants on preventing foot care complications associated with DM. All data were analyzed using reflexive thematic analysis. RESULTS: Participants were challenged to consistently make health choices that were congruent with recommended DM self-management for the prevention of DFD. In addition, participants intuited multiple mixed messages from healthcare providers and workplaces that appeared to diminish their individual responsibility to self-manage their DM. Findings were organized under two main themes: a) Ineffective coping: Distancing self from disease b) Vacillating responsibility: Multiple mixed messages. CONCLUSIONS: Nurses are in a unique position to provide the education and support needed to assist individuals in carrying out the many recommended self-care strategies to reduce the risk of DFD. Contextually, nurses must encourage consistent messaging among health care providers and workplaces to prioritize the health needs of individuals living with diabetes and to support the challenging work these individuals must navigate every day. It will take a concerted effort to reinforce the message that diabetes care is a priority for everyone.

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.

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.

Digital Foot Technology in Ulcer Prevention and Reulceration: A Clinical Perspective.

BACKGROUND: Studies have shown that personal and economic reasons determine whether clinicians use diagnostic technology in their routine clinical biomechanical practice. This study aimed to identify the biomechanical management plan of local clinicians in relation to management of the diabetic high-risk foot and to investigate whether diagnostic technology is being used to determine the effectiveness of dispensed prescription orthoses in view of ulcer prevention. METHODS: A mixed-methodologic approach was adopted in this study. A retrospective quantitative study was also conducted to access records of patients attending the biomechanics clinic at a local health biomechanics clinic. Outcomes of interest included the number and percentage of patients attending the biomechanics clinic, source of referral to this clinic, age and gender of patients, clinical diagnosis, management plan, and referral pathway. Following a phenomenologic approach, four experienced clinicians working in the private, primary, and tertiary health sectors were interviewed. Thematic analysis was used to analyze and interpret data. RESULTS: Only low-risk patients living with diabetes mellitus were referred for a comprehensive biomechanical examination; the majority were referred by podiatrists. There was no record of diabetic high-risk patients being referred for a detailed biomechanical assessment within the health service. This study also confirmed that, because of the expenses and laborious work involved when using diagnostic technology to assess foot pressures, interviewed clinicians based their treatment plan and tested the efficiency of dispensed offloading devices on the basis of clinical experience and visual observation only. CONCLUSIONS: Waiting for signs of ulceration can be too late for the high-risk foot. A change in clinical practice is recommended where the integration of diagnostic technology, together with standard care, in view of ulcer prevention is warranted.

Australian evidence-based guidelines for the prevention and management of diabetes-related foot disease: a guideline summary.

INTRODUCTION: Diabetes-related foot disease (DFD) - foot ulcers, infection, ischaemia - is a leading cause of hospitalisation, disability, and health care costs in Australia. The previous 2011 Australian guideline for DFD was outdated. We developed new Australian evidence-based guidelines for DFD by systematically adapting suitable international guidelines to the Australian context using the ADAPTE and GRADE approaches recommended by the NHMRC. MAIN RECOMMENDATIONS: This article summarises the most relevant of the 98 recommendations made across six new guidelines for the general medical audience, including: prevention - screening, education, self-care, footwear, and treatments to prevent DFD; classification - classifications systems for ulcers, infection, ischaemia and auditing; peripheral artery disease (PAD) - examinations and imaging for diagnosis, severity classification, and treatments; infection - examinations, cultures, imaging and inflammatory markers for diagnosis, severity classification, and treatments; offloading - pressure offloading treatments for different ulcer types and locations; and wound healing - debridement, wound dressing selection principles and wound treatments for non-healing ulcers. CHANGES IN MANAGEMENT AS A RESULT OF THE GUIDELINE: For people without DFD, key changes include using a new risk stratification system for screening, categorising risk and managing people at increased risk of DFD. For those categorised at increased risk of DFD, more specific self-monitoring, footwear prescription, surgical treatments, and activity management practices to prevent DFD have been recommended. For people with DFD, key changes include using new ulcer, infection and PAD classification systems for assessing, documenting and communicating DFD severity. These systems also inform more specific PAD, infection, pressure offloading, and wound healing management recommendations to resolve DFD.

Implementing an integrated diabetic foot care programme in Ireland: podiatrists' experience.

BACKGROUND: International evidence suggests that an integrated multidisciplinary approach to diabetic foot management is necessary to prevent ulceration and progression to amputation. Many health systems have introduced policies or models of care supporting the introduction of this evidence into practice, but little is known about the experiences of those involved in implementation. This study addresses this gap by examining the experiences of podiatrists providing integrated diabetic foot care. METHODS: Between October 2017 and April 2018, an online survey comprising closed and open-ended questions on podiatrists' demographics, clinical activity, links with other services, continuous professional development activities and experiences of implementing the Model of Care was administered to podiatrists (n = 73) working for Ireland's Health Service Executive in the community and hospital setting. Data were analysed using descriptive statistics and qualitative content analysis. RESULTS: The response rate was 68% (n = 50), with 46% (n = 23), 38% (n = 19) and 16% (n = 8) working across hospital, community and both settings, respectively. Most reported treating high-risk patients (66%), those with active foot disease (61%) and educating people about the risk of diabetes to the lower limb (80%). Reported challenges towards integrated diabetic foot care include a perceived lack of awareness of the role of podiatry amongst other healthcare professionals, poor integration between hospital and community podiatry services, especially where new services had been developed, and insufficient number of podiatrists to meet service demands. CONCLUSION: Previous evidence has shown that there is often a gap between what is set out by a policy and what it looks like when delivered to service users. Results from the current study support this, highlighting that while most podiatrists work in line with national recommendations, there are specific gaps and challenges that need to be addressed to ensure successful policy implementation.

Adherence to diabetic foot care recommendations and associated factors among people with diabetes in Eastern Ethiopia: a multicentre cross-sectional study.

OBJECTIVE: This study aimed to determine the level of adherence to foot care recommendations and associated factors among people with diabetes on follow-up in public hospitals in Eastern Ethiopia. SETTING: An institutional-based cross-sectional study was conducted in public hospitals found in Eastern Ethiopia from 25 February to 25 March 2022. PARTICIPANTS: A total of 419 patients with chronic diabetes who visited diabetic clinics in public hospitals in Eastern Ethiopia for follow-up were included. MAIN OUTCOME MEASURE: The level of adherence to diabetic foot care recommendations and associated factors. RESULTS: The findings indicated that 44.3% (95% CI: 39.3, 49.0) of people with diabetes had inadequate adherence to diabetic foot care recommendations. Age between 28-37 (adjusted OR (AOR)=1.10; 95% CI: 1.27, 5.63) and 38-47 years (AOR=2.19; 95% CI: 2.74, 8.89), rural residence (AOR=1.71; 95% CI: 1.15, 2.57), absence of comorbidity (AOR=2.22; 95% CI:1.34, 5.14), obesity (AOR=1.43; 95% CI: 1.10, 5.05) and inadequate foot care knowledge (AOR=2.10; 95% CI: 1.52, 4.35) were factors significantly associated with inadequate adherence to diabetic foot care recommendations. CONCLUSION: More than two-fifths of people with diabetes had inadequate adherence to diabetic foot care recommendations. Younger age, rural residence, absence of comorbidity, obesity and inadequate foot care knowledge were significantly associated with inadequate adherence to diabetic foot care recommendations. It is very essential to educate people with diabetes about the importance of foot care recommendations in preventing and delaying the risks of foot-related problems and complications.

[Summary of the best evidence on exercise for the prevention and treatment of diabetic foot].

Objective: To summarize the best evidence on exercise for the prevention and treatment of diabetic foot. Methods: A bibliometric approach was used. Systematic searches were carried out to retrieve all the publicly published evidences till July 2022 on exercise for the prevention and treatment of diabetic foot, including guidelines, evidence summary, recommended practices, expert consensus, systematic review, and original research, from foreign language databases including BMJ Best Practice, UpToDate, Joanna Briggs Institute Evidence-Based Practice Database, Cochrane Library, Embase, PubMed, Guideline International Network, National Guideline Clearinghouse, Chinese databases including China National Knowledge Infrastructure, Wanfang Database, VIP Database, China Biology Medicine disc, China Clinical Guidelines Library, and the official websites of relevant academic organizations including National Institute for Health and Care Excellence of the United Kingdom, Registered Nurses' Association of Ontario of Canada, the International Working Group on the Diabetic Foot, International Diabetes Federation, American College of Sports Medicine, American Diabetes Association, and Chinese Diabetes Society. The literature was screened and evaluated for the quality, from which the evidences were extracted and evaluated to summarize the best evidences. Results: Nine guidelines, three expert consensuses, one evidence summary (with two systematic reviews being traced), two systematic reviews, 6 randomized controlled trials were retrieved and included, with good quality of literature. Totally 33 pieces of best evidences on exercise for the prevention and treatment of diabetic foot were summarized from the aspects of appropriate exercise prevention of diabetic foot, exercise therapy of diabetic foot, precautions for exercise, health education, and establishment of a multidisciplinary limb salvage team. Conclusions: Totally 33 pieces of best evidences on exercise for the prevention and treatment of diabetic foot were summarized from 5 aspects, providing decision-making basis for clinical guidance on exercise practice for patients with diabetic foot.

An integrated personalized assistive devices approach to reduce the risk of foot ulcer recurrence in diabetes (DIASSIST): study protocol for a multicenter randomized controlled trial.

BACKGROUND: Preventing foot ulcers in people with diabetes can increase quality of life and reduce costs. Despite the availability of various interventions to prevent foot ulcers, recurrence rates remain high. We hypothesize that a multimodal treatment approach incorporating various footwear, self-management, and education interventions that matches an individual person's needs can reduce the risk of ulcer recurrence with beneficial cost-utility. The aim of this study is to assess the effect on foot ulcer recurrence, footwear adherence, and cost-utility of an integrated personalized assistive devices approach in high-risk people with diabetes. METHODS: In a parallel-group multicenter randomized controlled trial, 126 adult participants with diabetes mellitus type 1 or 2, loss of protective sensation based on the presence of peripheral neuropathy, a healed plantar foot ulcer in the preceding 4 years, and possession of any type of custom-made footwear will be included. Participants will be randomly assigned to either enhanced therapy or usual care. Enhanced therapy consists of usual care and additionally a personalized treatment approach including pressure-optimized custom-made footwear, pressure-optimized custom-made footwear for indoor use, at-home daily foot temperature monitoring, and structured education, which includes motivational interviewing and personalized feedback on adherence and self-care. Participants will be followed for 12 months. Assessments include barefoot and in-shoe plantar pressure measurements; questionnaires concerning quality of life, costs, disease, and self-care knowledge; physical activity and footwear use monitoring; and clinical monitoring for foot ulcer outcomes. The study is powered for 3 primary outcomes: foot ulcer recurrence, footwear adherence, and cost-utility, the primary clinical, patient-related, and health-economic outcome respectively. DISCUSSION: This is the first study to integrate multiple interventions for ulcer prevention into a personalized state-of-the-art treatment approach and assess their combined efficacy in a randomized controlled trial in people with diabetes at high ulcer risk. Proven effectiveness, usability, and cost-utility will facilitate implementation in healthcare, improve the quality of life of high-risk people with diabetes, and reduce treatment costs. TRIAL REGISTRATION: ClinicalTrials.gov NCT05236660. Registered on 11 February 2022.

Evaluation of in-shoe plantar pressure and shear during walking for diabetic foot ulcer prevention.

OBJECTIVE: To investigate reliability and changes of in-shoe plantar pressure and shear during walking at three cadences with two insole designs. This was a precursor to the investigation of plantar loading in people with diabetes for potential foot ulcer prevention. METHOD: A sensorised insole system, capable of measuring plantar pressure and shear at the heel, fifth metatarsal head (5MH), first metatarsal head (1MH) and hallux, was tested with ten healthy participants during level walking. Reliability was evaluated, using intra-class correlation coefficient (ICC), while varying the cadences and insole types. Percentage changes in pressure and shear relative to values obtained at self-selected cadence with a flat insole design were investigated. RESULTS: Mean±standard deviation of maximum pressure, medial-lateral and anterior-posterior shear of up to 380±24kPa, 46±2kPa and -71±4kPa, respectively, were measured. The ICC in ranges of 0.762-0.973, 0.758-0.987 and 0.800-0.980 were obtained for pressure, anterior-posterior and medial-lateral shear, respectively. Opposite anterior-posterior shear directions between 5MH and 1MH (stretching), and between 1MH and hallux (pinching) were observed for some participants. Increasing cadence increased pressure and anterior-posterior shear (by up to +77%) but reduced medial-lateral shear at the heel and hallux (by up to -34%). Slower cadence increased anterior-posterior shear (+114%) but decreased medial-lateral shear (-46%) at the hallux. The use of a flexible contoured insole resulted in pressure reduction at the heel and 5MH but an increase in anterior-posterior shear at the heel (+69%) and hallux (+75%). CONCLUSION: The insole system demonstrated good reliability and is comparable to reported pressure-only systems. Pressure measurements were sensitive to changes in cadence and insole designs in ways that were consistent with the literature. However, our plantar shear showed localised shear changes with cadences and insoles for the first time, as well as stretching and pinching effects on plantar tissue. This opens new possibilities to investigate plantar tissue viability, loading characteristics and orthotic designs aimed towards foot ulcer prevention.

Objectively assessed long-term wearing patterns and predictors of wearing orthopaedic footwear in people with diabetes at moderate-to-high risk of foot ulceration: a 12 months observational study.

BACKGROUND: Orthopaedic footwear can only be effective in preventing diabetic foot ulcers if worn by the patient. Robust data on long-term wearing time of orthopaedic footwear are not available, and needed to gain more insights into wearing patterns and associated factors (i.e. participants' demographic, disease-related characteristics, and footwear usability). We aimed to objectively assess long-term wearing patterns and identify factors associated with wearing orthopaedic footwear in people with diabetes at moderate-to-high risk of ulceration. METHODS: People diagnosed with diabetes mellitus type 1 and 2 with loss of protective sensation and/or peripheral artery disease and prescribed with orthopaedic footwear were included and followed for 12 months. The primary outcome was mean daily wearing time, continuously measured using a temperature sensor inside the footwear (Orthotimer®). Adherence to wearing orthopaedic footwear was calculated as percentage of wearing time of a total assumed 16 h out-of-bed daytime, where adherence < 60% was a pre-determined non-adherent threshold. Wearing time patterns were assessed by calculating participants' wearing (in)consistency. One-way analyses of variance tested for wearing time differences between subgroups, weekdays, and weekend days. Factors potentially associated with wearing time were collected by questionnaires and medical files. Univariately associated factors were included in multivariate linear regression analysis. RESULTS: Sixty one participants were included (mean (SD) age: 68.0 (7.4) years; females: n = 17; type 2 diabetes mellitus: n = 54). Mean (SD) overall daily wearing time was 8.3 (6.1) hours/day. A total of 40 (66%) participants were non-adherent. Participants with a consistent wearing pattern showed higher daily wearing times than participants with an inconsistent pattern. Mean (SD) wearing times were 12.7 (4.3) vs 3.6 (4.8) hours/day, respectively (P < 0.001). Mean (SD) wearing time was significantly higher (P < 0.010) during weekdays (8.7 (6.0) hours/day) compared to Saturday (8.0 (6.1) hours/day) and Sunday (6.9 (6.2) hours/day). In the multivariate model (R2 = 0.28), "satisfaction with my wear of orthopaedic footwear" was positively associated (P < 0.001) with wearing time. The other seven multivariate model factors (four demographic variables and three footwear usability variables) were not associated with wearing time. CONCLUSIONS: Only one out of three people at moderate to high risk of foot ulceration were sufficiently adherent to wearing their orthopaedic footwear. Changing people's wearing behaviour to a more stable pattern seems a potential avenue to improve long-term adherence to wearing orthopaedic footwear. Investigated factors are not associated with daily wearing time. Based on these factors the daily wearing time cannot be estimated in daily practice. TRIAL REGISTRATION: Netherlands Trial Register NL7710. Registered: 6 May 2019.

Knowledge, attitudes, and practice of Endocrinology healthcare workers regarding screening for pre-ulcerative diabetic foot lesions.

OBJECTIVE: To investigate knowledge, attitude and practice of screening pre-ulcerative lesions among endocrinology healthcare workers. METHODS: A new questionnaire was developed and distributed online and 1004 valid questionnaires were returned. T-test, ANOVA, Pearson correlation analysis, and multiple linear regression were used for statistical analysis. RESULTS: A total of 1100 questionnaires were returned, and 96 were excluded. The scores of endocrinology healthcare workers' knowledge, attitude, and practice for screening for pre-ulcerative lesions were 45.46 ± 16.26, 92.11 ± 10.50, and 72.27 ± 17.63 respectively. 60.2% participants had been trained to screen for pre-ulcerative lesions, but 39.8% had not been trained. 31.8% of healthcare professionals claimed that their hospital did not have a screening project for pre-ulcer diabetic foot lesions. Positive relationships were found between knowledge and practice and between attitude and practice. Multiple linear regression analysis showed that: level II hospital and tertiary hospital were the main factors influencing the knowledge scores; Undergraduate and participating in relevant training were the main factors influencing the attitude scores; participating in relevant training, hospital conducts relevant projects, and patient cooperation, and working hours were the main factors influencing the practice score. CONCLUSIONS: Endocrinology healthcare workers need more knowledge regarding pre-ulcerative lesions, and their screening practices need to be strengthened. Increased education and training for pre-ulcerative lesion screening should be implemented among healthcare workers in endocrinology departments.