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.

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 quest for wellness: How to optimise self-care strategies for diabetic foot management?

Diabetic foot ulceration (DFU) is common and highly recurrent, negatively impacting the individuals' quality of life. The 2023 guidelines of the International Working Group on the Diabetic Foot emphasise that adherence to foot self-care recommendations is one of the most important factors in DFU prevention. These guidelines also briefly mention that depression and other psychosocial problems can hamper treatment and ulcer healing. Moreover, a new clinical question was added on psychological interventions for ulcer prevention, although the evidence regarding the role of psychological and social factors is still limited. To help the field progress, this narrative overview discusses how a stronger focus on psychological factors by both researchers and clinicians could improve the care for people at high DFU risk. The review starts with a testimony of a person living with DFU, explaining that for him, the absence of shared decision-making has been a key barrier to successful foot self-care implementation. Intervention studies that address patient-reported barriers are still scarce, and are therefore urgently needed. Furthermore, the key elements of psychological interventions found to be successful in managing diabetes are yet to be implemented in DFU risk management. Importantly, research evidence indicates that commonly advocated foot self-care recommendations may be insufficient in preventing DFU recurrence, whereas digital technology appears to effectively reduce recurrent DFU. More research is therefore needed to identify determinants of patient acceptance of digital technology.

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.

Understanding how and why upskilling programmes for unregulated care providers can support health equity in underserved communities: a realist review protocol.

INTRODUCTION: Foot ulcers are one of the most devastating complications of diabetes mellitus leading to leg amputations. In Canada, systematically marginalised and racialised populations are more prone to developing foot ulcers and at higher risk of limb amputations. Shortages of regulated healthcare have hindered efforts to provide foot care. Upskilling unregulated care providers (UCPs) to deliver foot screening seems a reasonable solution to reduce limb loss. UCPs can advocate for health equity and deliver appropriate care. There is a need, however, to understand how and why an educational intervention for UCPs providing foot screening for these high-risk groups may or may not work. METHODS AND ANALYSIS: This realist review will follow the Realist And Meta-narrative Evidence Syntheses: Evolving Standards standards. First, we will develop an initial programme theory (PrT) based on exploratory searches and discussions with experts and stakeholders. Then, we will search MEDLINE, Embase, PsycINFO, ERIC, CINAHL and Scopus databases along with relevant sources of grey literature. The retrieved articles will be screened for studies focusing on planned educational interventions for UCPs related to diabetic foot assessment. Data regarding contexts, mechanisms and outcomes will be extracted and analysed using a realist analysis through an iterative process that includes data reviewing and consultation with our team. Finally, we will use these results to modify the initial PrT. ETHICS AND DISSEMINATION: Ethical approval is not required for this review. The main output of this research will be an evidence-based PrT for upskilling programmes for UCPs. We will share our final PrT using text, tables and infographics to summarise our results and draw insights across papers/reports. For academic, clinical, social care and educational audiences, we will produce peer-reviewed journal articles, including those detailing the process and findings of the realist review and establishing our suggestions for effective upskilling programmes. PROSPERO REGISTRATION NUMBER: CRD42022369208.

Preventative Sensor-Based Remote Monitoring of the Diabetic Foot in Clinical Practice.

Diabetes and its complications, particularly diabetic foot ulcers (DFUs), pose significant challenges to healthcare systems worldwide. DFUs result in severe consequences such as amputation, increased mortality rates, reduced mobility, and substantial healthcare costs. The majority of DFUs are preventable and treatable through early detection. Sensor-based remote patient monitoring (RPM) has been proposed as a possible solution to overcome limitations, and enhance the effectiveness, of existing foot care best practices. However, there are limited frameworks available on how to approach and act on data collected through sensor-based RPM in DFU prevention. This perspective article offers insights from deploying sensor-based RPM through digital DFU prevention regimens. We summarize the data domains and technical architecture that characterize existing commercially available solutions. We then highlight key elements for effective RPM integration based on these new data domains, including appropriate patient selection and the need for detailed clinical assessments to contextualize sensor data. Guidance on establishing escalation pathways for remotely monitored at-risk patients and the importance of predictive system management is provided. DFU prevention RPM should be integrated into a comprehensive disease management strategy to mitigate foot health concerns, reduce activity-associated risks, and thereby seek to be synergistic with other components of diabetes disease management. This integrated approach has the potential to enhance disease management in diabetes, positively impacting foot health and the healthspan of patients living with diabetes.

Diabetic Foot Ulcers: Contemporary Assessment And Management.

Diabetic foot ulcer disease is the combination of vasculopathy, neuropathy and infection. It is important to identify the main aetiology and to treat it for optimal ulcer healing so that limb amputation may be prevented. A literature review spanning five years (2018-2021) was performed to assess the current understanding of these aetiologies and management options for their treatment. Peripheral artery disease is prevalent in patients with diabetes. Before performing any amputations, whether minor or major, vascular supply in these patients needs to be evaluated and, if needed, improved. Diabetic neuropathy is a long-term complication of uncontrolled diabetes. Patients' education is very important with respect to selfcare and prevention of foot complications arising out of minor trauma in diabetic population. Better foot care and regular use of off-loading shoe wear can prevent neuropathic diabetic foot ulcers. Infection in diabetic patients is mostly polymicrobial and it can present as superficial or deep infections. Early diagnosis, use of broad-spectrum antibiotics, and aggressive debridement, when needed, is advocated to prevent foot amputation. Contemporary treatment armamentarium provides many options for treating diabetic foot ulcers. Nevertheless, one must exhaust all preventive strategies to avoid ulcers in the first place. Once an ulcer has developed, it should be managed aggressively with appropriate soft tissue and, if required, with bony procedures. The current narrative review was planned to explore the current understanding about the main aetiologies of diabetic foot ulcers and about the available treatment options.

Patient Perspectives on the Burden and Prevention of Diabetes-Related Foot Disease.

PURPOSE: The purpose of the study was to understand patient perspectives about the impact and prevention of diabetes-related foot disease (DFD). METHODS: An online survey was distributed to patients with a history of DFD during 2020. The survey was designed alongside clinical specialists and DFD patients and utilized the health belief model. It asked about the impact of DFD on health, perceptions on preventive strategies, perceived need for additional support, and patient preferences for telehealth in DFD management. Quantitative data were summarized descriptively and compared between groups. Open-text responses were analyzed using conceptual content analysis. RESULTS: Of 80 participants with a history of DFD, foot ulcers were the complication most often experienced, with over two-thirds having been admitted to hospital for a DFD-related issue and over one-third having a DFD-related amputation. Participants had ranging perceptions on the effect of DFD on health, from minimal to crippling. Those with previous severe DFD complications leading to hospital admission found a lack of mobility and independence the consequences of most concern. Using offloading footwear was perceived as very important for preventing DFD complications, although the use of offloading footwear was low, with participants citing issues relating to cost, comfort, appearance, and access to footwear as barriers to better adherence. Perceptions on telehealth were mixed, with many participants not having access to or being comfortable with the use of digital technologies. CONCLUSIONS: Patients with DFD require additional supports for effective prevention, including offloading footwear.

What are the current diabetic foot assessment methods in private podiatry practices in Flanders, Belgium: an exploratory mixed method study.

BACKGROUND: Diabetic foot assessments detect patients at risk for developing a diabetes-related foot ulceration and can significantly reduce the risk of amputation. In order to organize this assessment effectively, diabetic foot assessment guidelines are required according to the International Working Group of the Diabetic Foot. However, these international guidelines have not been adapted into a national guideline for podiatrists in Flanders, Belgium. This study aims to identify the methods and guidelines currently used to assess the diabetic foot in private podiatry practices in Flanders, Belgium and to explore the podiatrists' opinions on developing a national diabetic foot assessment guideline. METHODS: This exploratory mixed method study was composed of an anonymous online survey comprising of open- and closed-ended questions followed by 1:1 online semi-structured interviews. Participants were recruited via e-mail and a closed private Facebook group of podiatry alumni. Data was analyzed using SPSS statistics and thematic analysis described by Braun and Clarke. RESULTS: This study showed that the vascular assessment of the diabetic foot exists solely of a medical history and palpation of the pedal pulses. Non-invasive tests such as doppler, toe brachial pressure index or ankle brachial pressure index are seldom used. Only 66% reported to use a guideline for the diabetic foot assessment. There was a variety of reported guidelines and risk stratification systems in use in private podiatry practices in Flanders, Belgium. CONCLUSION: Non-invasive tests such as the doppler, ankle brachial pressure index or toe brachial pressure index are rarely used for the vascular assessment of the diabetic foot. Diabetic foot assessment guidelines and risk stratification systems to identify patients at risk for developing a diabetic foot ulcer were not frequently used. International guidelines of the International Working Group of the Diabetic Foot have not yet been implemented in private podiatry practices in Flanders, Belgium. This exploratory research has provided useful information for future research studies.

Reliability of the evidence to guide decision-making in foot ulcer prevention in diabetes: an overview of systematic reviews.

BACKGROUND: Reliable evidence on the effectiveness of interventions to prevent diabetes-related foot ulceration is essential to inform clinical practice. Well-conducted systematic reviews that synthesise evidence from all relevant trials offer the most robust evidence for decision-making. We conducted an overview to assess the comprehensiveness and utility of the available secondary evidence as a reliable source of robust estimates of effect with the aim of informing a cost-effective care pathway using an economic model. Here we report the details of the overview. [PROSPERO Database (CRD42016052324)]. METHODS: Medline (Ovid), Embase (Ovid), Epistomonikos, Cochrane Database of Systematic Reviews (CDSR), Database of Abstracts of Reviews of Effectiveness (DARE), and the Health Technology Assessment Journals Library were searched to 17th May 2021, without restrictions, for systematic reviews of randomised controlled trials (RCTs) of preventive interventions in people with diabetes. The primary outcomes of interest were new primary or recurrent foot ulcers. Two reviewers independently extracted data and assessed the risk of bias in the included reviews. FINDINGS: The overview identified 30 systematic reviews of patient education, footwear and off-loading, complex and other interventions. Many are poorly reported and have fundamental methodological shortcomings associated with increased risk of bias. Most concerns relate to vague inclusion criteria (60%), weak search or selection strategies (70%) and quality appraisal methods (53%) and inexpert conduct and interpretation of quantitative and narrative evidence syntheses (57%). The 30 reviews have collectively assessed 26 largely poor-quality RCTs with substantial overlap. INTERPRETATION: The majority of these systematic reviews of the effectiveness of interventions to prevent diabetic foot ulceration are at high risk of bias and fail to provide reliable evidence for decision-making. Adherence to the core principles of conducting and reporting systematic reviews is needed to improve the reliability of the evidence generated to inform clinical practice.

Diabetic foot workshop: A strategy for improving the knowledge of diabetic foot care providers.

BACKGROUND AND AIMS: Prevention and management of diabetic foot ulcer have essential effects on the quality of life of patients. Accordingly training the care providers can play an essential role in reducing complications foot ulcers and lead to an increase in the effectiveness and efficiency of patient health cares. We conducted a study to survey the impact of the diabetic foot workshop on the knowledge of nurses and physicians about diagnosis and managing diabetic foot. METHODS: The present study is a quasi-experimental which compare the knowledge of non-randomized group of nurses and physicians about diabetic foot care. The leaning objectives, agenda, contents and evaluation methods of the diabetic foot care workshop was designed by a multidisciplinary team members in form of 2 days workshop. Each topic of the workshop presented theoretically and practically using educational cases and real patient with diabetic foot ulcer. A valid and reliable questionnaire with 20 Multiple Choice Questions used for the evaluation of workshopin form of the pretest and posttest. RESULTS: In this study, 396 registered nurses and physicians participates in the diabetic foot workshop series. The results of this study showed that this increase in the level of knowledge was meaningful after the educational intervention since the mean of the posttest score increased more than 20% comparing with pretest. CONCLUSION: The promotion of knowledge of health care providers as shown in the study may almost be due to training by real patient, team-working, and using educational movies for the education of diabetic foot diagnosis, management and rehabilitation.

Diabetic foot ulcer risk assessment and prevention in patients with diabetes: a best practice implementation project.

INTRODUCTION AND AIM: Diabetic foot ulcer (DFU) is one of the most serious complications in patients with diabetes. Early identification of risk factors can prevent its occurrence and delay its progression. The aim of this project is to conduct an audit of DFU risk assessment protocols at a large tertiary hospital and evaluate the impact of any changes in compliance with the developed evidence-based best practice criteria. METHODS: Preimplementation and postimplementation audits based on JBI's Practical Application of Clinical Evidence System were conducted at the Department of Endocrinology and Metabolism of a tertiary hospital in China. The Getting Research into Practice audit tool was used to analyze the barriers and inadequacies encountered in practice. A total of 12 nurses and 30 patients with diabetes were included in the baseline and follow-up audits. RESULTS: There were 15 baseline audits that indicated deficits in DFU risk assessment by nurses, with 0% compliance for three criteria and 50% compliance or less for seven others. Strategies developed by the project team to address the identified barriers to compliance were adopted, leading to significant improvement in compliance with most criteria at the follow-up audit compared with baseline with 11 criteria achieving at least 90% compliance. CONCLUSION: The project showed that regular audits of foot ulcer risk assessment can help to identify barriers to their implementation. Advising patients of their risk status can support appropriate self-care practices. Further audits are needed to implement evidence-based practices in all aspects of diabetes patient care.

Clinical and economic outcomes of a multidisciplinary team approach in a lower extremity amputation prevention programme for diabetic foot ulcer care in an Asian population: A case-control study.

Present guidelines recommend a multidisciplinary team (MDT) approach to diabetic foot ulcer (DFU) care, but relevant data from Asia are lacking. We aim to evaluate the clinical and economic outcomes of an MDT approach in a lower extremity amputation prevention programme (LEAPP) for DFU care in an Asian population. We performed a case-control study of 84 patients with DFU between January 2017 and October 2017 (retrospective control) vs 117 patients with DFU between December 2017 and July 2018 (prospective LEAPP cohort). Comparing the clinical outcomes between the retrospective cohort and the LEAPP cohort, there was a significant decrease in mean time from referral to index clinic visit (38.6 vs 9.5 days, P < .001), increase in outpatient podiatry follow-up (33% vs 76%, P < .001), decrease in 1-year minor amputation rate (14% vs 3%, P = .007), and decrease in 1-year major amputation rate (9% vs 3%, P = .05). Simulation of cost avoidance demonstrated an annualised cost avoidance of USD $1.86m (SGD $2.5m) for patients within the LEAPP cohort. In conclusion, similar to the data from Western societies, an MDT approach in an Asian population, via a LEAPP for patients with DFU, demonstrated a significant reduction in minor and major amputation rates, with annualised cost avoidance of USD $1.86m.

Cost-Effectiveness of Lower Extremity Nerve Decompression Surgery in the Prevention of Ulcers and Amputations: A Markov Analysis.

BACKGROUND: The costs and health effects associated with lower extremity complications in diabetes mellitus are an increasing burden to society. In selected patients, lower extremity nerve decompression is able to reduce symptoms of neuropathy and the concomitant risks of diabetic foot ulcers and amputations. To estimate the health and economic effects of this type of surgery, the cost-effectiveness of this intervention compared to current nonsurgical care was studied. METHODS: To estimate the incremental cost-effectiveness of lower extremity nerve decompression over a 10-year period, a Markov model was developed to simulate the onset and progression of diabetic foot disease in patients with diabetes and neuropathy who underwent lower extremity nerve decompression surgery, compared to a group undergoing current nonsurgical care. Mean survival time, health-related quality of life, presence or risk of lower extremity complications, and in-hospital costs were the outcome measures assessed. Data from the Rotterdam Diabetic Foot Study were used as current care, complemented with information from international studies on the epidemiology of diabetic foot disease, resource use, and costs, to feed the model. RESULTS: Lower extremity nerve decompression surgery resulted in improved life expectancy (88,369.5 life-years versus 86,513.6 life-years), gain of quality-adjusted life-years (67,652.5 versus 64,082.3), and reduced incidence of foot complications compared to current care (490 versus 1087). The incremental cost-effectiveness analysis was -€59,279.6 per quality-adjusted life-year gained, which is below the Dutch critical threshold of less than €80,000 per quality-adjusted life-year. CONCLUSIONS: Decompression surgery of lower extremity nerves improves survival, reduces diabetic foot complications, and is cost saving and cost-effective compared with current care, suggesting considerable socioeconomic benefit for society.

Toe gaps and their assessment in footwear for people with diabetes: a narrative review.

BACKGROUND: Adequate footwear fit is critical in preventing diabetes-related foot ulcers. One important element is the toe gap, the difference between foot length and internal footwear length available to the foot. We summarised the literature on toe gaps in studies assessing footwear worn by people with diabetes, the methods used to measure both foot length and internal footwear length and identify ambiguities which may impact on toe gap assessment in clinical practice, and suggest pragmatic solutions. METHODS: The Google Scholar database was searched to April 2020 for peer-reviewed studies using keywords related to incorrectly fitting or ill-fitting and diabetes, foot and ulcer which returned 979 results. Included studies within this narrative review encompassed toe gap measurement to assess footwear worn by people with diabetes. RESULTS: A total of eight studies were included after full paper review. Toe gap ranges as used in assessments of footwear worn by people with diabetes vary, with a minimum of 1.0-1.6 cm and a maximum of 1.5-2.0 cm, as do methods of measuring internal footwear length. Only three published studies suggested possible measuring devices. CONCLUSIONS: Toe gap ranged as used when assessing footwear fit in people with diabetes vary and a gold standard device for internal footwear length measurement has yet to emerge. International guidelines provide welcome standardisation, but further research is needed to evaluate both the effect of toe gap ranges upon pressure, plantar stress response and ulceration and available measuring devices to facilitate development of toe gap measurement protocols that may further enhance consistency in practical assessments.

Risk assessments and structured care interventions for prevention of foot ulceration in diabetes: development and validation of a prognostic model.

BACKGROUND: Diabetes-related foot ulcers give rise to considerable morbidity, generate a high monetary cost for health and social care services and precede the majority of diabetes-related lower extremity amputations. There are many clinical prediction rules in existence to assess risk of foot ulceration but few have been subject to validation. OBJECTIVES: Our objectives were to produce an evidence-based clinical pathway for risk assessment and management of the foot in people with diabetes mellitus to estimate cost-effective monitoring intervals and to perform cost-effectiveness analyses and a value-of-information analysis. DESIGN: We developed and validated a prognostic model using predictive modelling, calibration and discrimination techniques. An overview of systematic reviews already completed was followed by a review of randomised controlled trials of interventions to prevent foot ulceration in diabetes mellitus. A review of the health economic literature was followed by the construction of an economic model, an analysis of the transitional probability of moving from one foot risk state to another, an assessment of cost-effectiveness and a value-of-information analysis. INTERVENTIONS: The effects of simple and complex interventions and different monitoring intervals for the clinical prediction rules were evaluated. MAIN OUTCOME MEASURE: The main outcome was the incidence of foot ulceration. We compared the new clinical prediction rules in conjunction with the most effective preventative interventions at different monitoring intervals with a 'treat-all' strategy. DATA SOURCES: Data from an electronic health record for 26,154 people with diabetes mellitus in one Scottish health board were used to estimate the monitoring interval. The Prediction Of Diabetic foot UlcerationS (PODUS) data set was used to develop and validate the clinical prediction rule. REVIEW METHODS: We searched for eligible randomised controlled trials of interventions using search strategies created for Ovid® (Wolters Kluwer, Alphen aan den Rijn, the Netherlands), MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials. Randomised controlled trials in progress were identified via the International Standard Randomised Controlled Trial Number Registry and systematic reviews were identified via PROSPERO. Databases were searched from inception to February 2019. RESULTS: The clinical prediction rule was found to accurately assess the risk of foot ulceration. Digital infrared thermometry, complex interventions and therapeutic footwear with offloading devices were found to be effective in preventing foot ulcers. The risk of developing a foot ulcer did not change over time for most people. We found that interventions to prevent foot ulceration may be cost-effective but there is uncertainty about this. Digital infrared thermometry and therapeutic footwear with offloading devices may be cost-effective when used to treat all people with diabetes mellitus regardless of their ulcer risk. LIMITATIONS: The threats to the validity of the results in some randomised controlled trials in the review and the large number of missing data in the electronic health record mean that there is uncertainty in our estimates. CONCLUSIONS: There is evidence that interventions to prevent foot ulceration are effective but it is not clear who would benefit most from receiving the interventions. The ulceration risk does not change over an 8-year period for most people with diabetes mellitus. A change in the monitoring interval from annually to every 2 years for those at low risk would be acceptable. FUTURE WORK RECOMMENDATIONS: Improving the completeness of electronic health records and sharing data would help improve our knowledge about the most clinically effective and cost-effective approaches to prevent foot ulceration in diabetes mellitus. STUDY REGISTRATION: This study is registered as PROSPERO CRD42016052324. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 62. See the NIHR Journals Library website for further project information.

People with diabetes sometimes have problems with their feet that can become serious and make getting around harder and life less enjoyable. We have developed a test based on a simple score to find out a person's risk of getting a foot ulcer. We also wanted to know how often the test needs to be done. People who have been tested and learn that they might go on to have foot problems rightly expect to be given treatment that stops the problem happening in the first place. In this project, we read many written reports about the best treatments to prevent foot ulcers. We found that some things can prevent foot ulcers, such as wearing special shoes and insoles, taking the temperature of the skin of the foot and resting when the temperature rises, and receiving specialist care from diabetes foot care teams. However, we also looked at the costs of the test and treatments and found that some treatments are better value for money than others. By using people's health data from NHS computers, we discovered that very few people with diabetes develop a worse risk score for foot ulcers as time goes on, and it seems that being tested every year is not necessary for everyone. New clinical trials might help to improve foot health for people with diabetes, but if all of the researchers who have collected data from people in clinical trials shared their data it would be possible to find out more about who will gain most from these treatments without spending a lot on new research. It is clear that better input of patients' health data into NHS computers will benefit diabetes research in the future.

Case-Control Study of Risk Factors and Self-Care Behaviors of Foot Ulceration in Diabetic Patients Attending Primary Healthcare Services in Palestine.

The purpose of this study is to identify certain sociodemographic, lifestyle, self-care, and foot examination factors that predict the development of diabetic foot ulcers in Palestine. A case-control study was performed in Palestine in 2019. The control group consisted of diabetic patients without foot ulceration (NFU). The case group included diabetic patients who had foot ulcers (DFU) with a size not less than 0.5 cm2. The sample of patients was taken from primary healthcare diabetic clinics in Palestine. Findings of the study showed several independent risk factors for developing DFUs, which were smoking, sensory loss to vibration, sensory loss to monofilament, loss of pedal pulse, presence of calluses, nephropathy, retinopathy, and neuropathy. Also, this study has shown that illiteracy and low income were significantly associated with DFU development. Moreover, the current study demonstrated that poor self-care behaviors were associated with DFU. The information gained from the study will contribute to raising awareness and improving health education for diabetic patients and their families with the aim of reducing the complications of diabetes.

Evaluation of the relationship among foot wound risk, foot self-care behaviors, and illness acceptance in patients with type 2 diabetes mellitus.

AIMS: Due to insufficient data in primary care, this study was designed to assess the influence of patient's foot self-care behaviors and illness acceptance on the risk of developing diabetic foot ulcers (DFU) in adults diagnosed with type 2 diabetes mellitus (DM). METHODS: This is a descriptive study with a clinical assessment element. Data were collected using a number of validated psychometric questionnaires that assess the participant's foot self care behavior, acceptance of Illness, symptoms and neuropathy. The study included 246 patients diagnosed with type 2 DM attending a designated family health center in Konya, Turkey. RESULTS: In the present study, there was a significant difference between DFSBS scores and gender and whether the patients resided in urban or rural areas (p < 0.05). A significant difference between AIS score and gender, educational status, social security, place of residence, and economic status of the participants was observed (p < 0.05). According to the results of regression analysis, gender, frequency of physician control visit (monthly), and foot care training predicted the DFSBS score, whereas gender, education, economic status, presence of other non-infectious diseases, hospitalization in the previous year, and OTNS results predicted the AIS score. Furthermore, the AIS and OTNS scores predicted the MNSI-Q score. CONCLUSIONS: In the family health centers, individuals who are at risk must be initially identified and efforts should be made to prevent complications and increase illness acceptance.