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Aims/hypothesis: Diabetic foot disease (DFD) is a leading cause of hospital admissions and amputations. Global trends in diabetes-related amputations have been previously reviewed, but trends in hospital admissions for multiple other DFD conditions have not. This review analysed the published incidence of hospital admissions for DFD conditions (ulceration, infection, peripheral artery disease [PAD], neuropathy) and diabetes-related amputations (minor and major) in nationally representative populations. Methods: PubMed and Embase were searched for peer-reviewed publications between 1 January 2001 and 5 May 2022 using the terms ‘diabetes’, ‘DFD’, ‘amputation’, ‘incidence’ and ‘nation’. Search results were screened and publications reporting the incidence of hospital admissions for a DFD condition or a diabetes-related amputation among a population representative of a country were included. Key data were extracted from included publications and initial rates, end rates and relative trends over time summarised using medians (ranges). Results: Of 2527 publications identified, 71 met the eligibility criteria, reporting admission rates for 27 countries (93% high-income countries). Of the included publications, 14 reported on DFD and 66 reported on amputation (nine reported both). The median (range) incidence of admissions per 1000 person-years with diabetes was 16.3 (8.4–36.6) for DFD conditions (5.1 [1.3–7.6] for ulceration; 5.6 [3.8–9.0] for infection; 2.5 [0.9–3.1] for PAD) and 3.1 (1.4–10.3) for amputations (1.2 [0.2–4.2] for major; 1.6 [0.3–4.3] for minor). The proportions of the reported populations with decreasing, stable and increasing admission trends were 80%, 20% and 0% for DFD conditions (50%, 0% and 50% for ulceration; 50%, 17% and 33% for infection; 67%, 0% and 33% for PAD) and 80%, 7% and 13% for amputations (80%, 17% and 3% for major; 52%, 15% and 33% for minor), respectively. Conclusions/interpretation: These findings suggest that hospital admission rates for all DFD conditions are considerably higher than those for amputations alone and, thus, the more common practice of reporting admission rates only for amputations may substantially underestimate the burden of DFD. While major amputation rates appear to be largely decreasing, this is not the case for hospital admissions for DFD conditions or minor amputation in many populations. However, true global conclusions are limited because of a lack of consistent definitions used to identify admission rates for DFD conditions and amputations, alongside a lack of data from low- and middle-income countries. We recommend that these areas are addressed in future studies. Registration: This review was registered in the Open Science Framework database (https://doi.org/10.17605/OSF.IO/4TZFJ). Graphical abstract: [Figure not available: see fulltext.].

Aims: Most diabetic foot ulcers are caused by tissue stress from being ambulatory in people without protective sensation. These ulcers are suggested to be preceded by local skin temperature increase due to inflammation of the underlying tissue, a so-called hotspot. Evidence to support this mechanism of ulcer development is meagre at best. We investigated if foot ulcers are preceded by increased skin temperature in people with diabetes and foot ulcer history. Material and Methods: Participants measured temperature at 6–8 plantar foot locations each day for 18 months and identified a hotspot with a temperature difference >2.2°C between corresponding foot locations for two consecutive days. Results: Twenty-nine of 151 participants developed a non-traumatic ulcer while adhering to temperature measurements. In the 2 months prior to ulceration, 8 (28%) had a true hotspot (i.e. at/adjacent to the ulcer location) and the hotspot was on average no longer present 9 days before ulceration. Seven (24%) participants had a false hotspot (i.e. at another location) and 14 (48%) had no hotspot. Conclusions: The skin of the majority of the ulcers does not heat up before it breaks down or, when it does, not directly before breakdown, questioning the foot temperature increase—uslcer association.

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.

Purpose: To assess users’ needs and expectations regarding custom-made indoor footwear, and to design such footwear with similar biomechanical efficacy and better usability compared to regular custom-made footwear in people with diabetes at risk for foot ulceration. Materials and methods: Multidisciplinary systematic design approach. Needs and expectations regarding indoor footwear were evaluated via a questionnaire in 50 high foot ulcer risk people with diabetes using custom-made footwear. We systematically designed indoor footwear, and manufactured this for nine participants. Primary requirement was similar plantar pressure compared to participants’ regular custom-made footwear. Results: Eighty-two percent of participants expressed a need for custom-made indoor footwear and 66% expected such footwear to increase their adherence. The custom-made indoor footwear had the same bottom construction as participants’ regular custom-made footwear, but with softer and more light-weight upper materials. Peak pressures were similar or lower, while qualitative evaluation showed better usability and lower costs for indoor footwear. Conclusions: People with diabetes at risk of foot ulceration expressed a clear need for custom-made indoor footwear, and expected such footwear to increase their adherence. Our indoor footwear design provides adequate pressure relief, with better usability, and can be produced at lower costs compared to regular custom-made footwear.Implications for rehabilitation People with diabetes at risk of foot ulceration express a need for special indoor footwear. We developed indoor footwear with similar offloading capacity as regular custom-made footwear. The indoor footwear is lighter in weight, easier to don/doff and lower in costs. At-risk people with diabetes expect this footwear to increase their footwear adherence.

The incidence of diabetes is increasing worldwide with concomitant raising number of patients with diabetic foot disease. Diabetic foot disease treatment has received more attention in the past decades, culminating in the creation of multidisciplinary outpatient clinics, but at the same time, complexity of patients seems to have increased. The aim of this article is to study differences in patient characteristics and outcomes (ulcer healing and ulcer-free survival days) in patients with a diabetic foot ulcer in two prospective cohorts with 15 years in between. Prospective cohort study of all patients in one diabetic foot centre of expertise in 2003-2004 and 2014-2018. Clinical outcomes were determined after a follow-up period of 12 months. Outcomes were differences in baseline characteristics and comorbidities, and differences in ulcer-related outcomes between both cohorts. We included all consecutive diabetic foot ulcer patients from our centre for the period 2003-2004 (n = 79) and 2014-2018 (n = 271). Age (67.0 +/- 14.3 vs. 71.6 +/- 11.5, p = 0.003) and prevalence of end-stage renal disease (1.3% vs. 7.7%, p = 0.036) were significantly higher in the more recent population. The more recent population had higher healing rate (53.2% vs. 76.4%, p < 0.001), higher median ulcer-free survival days once an ulcer had healed [173 days (IQR 85.3-295.5) vs. 257.0 (IQR 157.0-318.0), p = 0.026], and fewer minor amputations (20.3% vs. 8.1%, p = 0.002). People with diabetic foot ulcers treated in 2014-2018 were older and more frequently diagnosed with ESRD, compared to this population in 2003-2004, while other characteristics were similar; ulcer-related outcomes were better.

Background The health-related quality of life (HRQoL) of people with diabetes-related foot complications has been increasingly reported, mostly from studies of people with a foot ulcer. The aim of this study was to assess HRQoL and determine factors associated with HRQoL in people with diabetes at high risk of foot ulceration. Methods In all, 304 participants enrolled in the Diabetic Foot Temperature Trial (DIATEMP) were included in the cross-sectional analysis. HRQoL was measured by the RAND® 36-Item Short Form Health Survey (SF-36) at baseline. Potential factors associated with HRQoL were analysed using multiple linear regression analyses for the eight domains of the SF-36. Results Participants were predominantly male (72%), mean age 64.6 (±10.5) years, 77% type 2 diabetes and mean duration of diabetes 20 (±14) years. Mean SF-36 domain scores for the General Health (49.2 ± 20.1), Role Physical (50.9 ± 44.7), Physical Function (58.5 ± 27.9) and Vitality domains (59.8 ± 21.6) were lower compared to the Mental Health (78.4 ± 18.0), Social Functioning (75.3 ± 24.2), Role Emotional (73.5 ± 38.9) and Bodily Pain (67.0 ± 27.0) domains. HRQoL was lower than Dutch population-based and general diabetes samples, but higher than in samples with an ulcer. Use of a walking aid was associated with lower HRQoL across all 8 SF-36 domains (β range − 0.20 to − 0.50), non-Caucasian descent was associated with lower HRQoL in 5 domains (β range − 0.13 to − 0.17). Not working, higher BMI and younger age were associated with lower HRQoL in 3 domains. Conclusions People at high risk of diabetes-related foot ulceration have reduced HRQoL that varies across domains, with the physical domains most affected. Assessing mobility, ethnicity, BMI and job status may be useful in daily practice to screen for people who might benefit from interventions targeting HRQoL. Trial registration Netherlands Trial Registration: NTR5403. Registered on 8 September 2015.

Aims: To perform an updated systematic review of randomised controlled trials examining the efficacy of at-home foot temperature monitoring in reducing the risk of a diabetes-related foot ulcer (DFU). Methods: Systematic review performed according to Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines. Risk-of-bias was assessed using version 2 of the Cochrane risk-of-bias tool. Meta-analyses were performed using random effect models. Leave-one-out sensitivity analyses and a sub-analysis excluding trials considered at high risk-of-bias assessed the consistency of the findings. The certainty of the evidence was assessed with GRADE. Results: Five randomised controlled trials involving 772 participants meeting the International Working Group on the Diabetic Foot (IWGDF) risk category 2 or 3 were included. All trials reported instructing participants to measure skin temperature at-home at six or more sites on each foot using a hand-held infra-red thermometer at least daily and reduce ambulatory activity in response to hotspots (temperature differences >2.2°C on two consecutive days between similar locations in both feet). One, one, and three trials were considered at low, moderate and high risk-of-bias, respectively. Participants allocated to at-home foot temperature monitoring had a reduced risk of developing a DFU (relative risk 0.51, 95% CI 0.31–0.84) compared to controls. Sensitivity and sub-analyses suggested that the significance of this finding was consistent. The GRADE assessment suggested a low degree of certainty in the finding. Conclusions: At-home daily foot temperature monitoring and reduction of ambulatory activity in response to hotspots reduce the risk of a DFU in moderate or high risk people with a low level of certainty.

INTRODUCTION: Weight-bearing physical activity is important for people with diabetes-related foot disease but may also contribute to ulceration or delayed ulcer healing. No overview of weight-bearing activity of people at different stages of foot disease is available. We aimed to summarise quantitatively measured daily activity levels in people with diabetes-related foot disease. METHODS: We systematically searched peer-reviewed literature for studies reporting objectively measured weight-bearing activity in people with diabetes-related foot disease. We calculated daily step counts' means (over studies) and weighted means (over participants). International Working Group on the Diabetic Foot (IWGDF) risk strata, different climates, and activity indoors versus outdoors were compared. RESULTS: From 1247 publications, 27 were included. Mean steps/day in people with IWGDF risk 1/2: 6125 (12 studies; 345 participants; weighted mean: 5384). In IWGDF risk 3: 6167 (8 studies; 291 participants; weighted mean: 6239). In those with a foot ulcer: 4248 (6 studies; 186 participants; weighted mean: 4484). People living in temperate oceanic climates are more active compared to those in hotter or more humid climates (mean steps/day for no ulcer: 7712 vs. 5224 [18 studies]; for ulcer: 6819 vs. 2945 [6 studies]). People are more active indoors than outdoors (mean 4047 vs. 2514 [3 studies]). CONCLUSION: Levels of weight-bearing physical activity are similar between people with diabetes at various risk levels for foot ulceration but lower for those with a foot ulcer. Weight-bearing activity differs depending on the climatological environment and is higher indoors than outdoors. These findings provide reference for intervention studies or for clinicians aiming to provide mobility advice in this population.

Diabetic foot disease (DFD) is a leading cause of hospital admissions and amputations. Global trends in diabetes-related amputations have been previously reviewed, but trends in hospital admissions for multiple other DFD conditions have not. This review analysed the published incidence of hospital admissions for DFD conditions (ulceration, infection, peripheral artery disease [PAD], neuropathy) and diabetes-related amputations (minor and major) in nationally representative populations.PubMed and Embase were searched for peer-reviewed publications between 1 January 2001 and 5 May 2022 using the terms 'diabetes', 'DFD', 'amputation', 'incidence' and 'nation'. Search results were screened and publications reporting the incidence of hospital admissions for a DFD condition or a diabetes-related amputation among a population representative of a country were included. Key data were extracted from included publications and initial rates, end rates and relative trends over time summarised using medians (ranges).Of 2527 publications identified, 71 met the eligibility criteria, reporting admission rates for 27 countries (93% high-income countries). Of the included publications, 14 reported on DFD and 66 reported on amputation (nine reported both). The median (range) incidence of admissions per 1000 person-years with diabetes was 16.3 (8.4-36.6) for DFD conditions (5.1 [1.3-7.6] for ulceration; 5.6 [3.8-9.0] for infection; 2.5 [0.9-3.1] for PAD) and 3.1 (1.4-10.3) for amputations (1.2 [0.2-4.2] for major; 1.6 [0.3-4.3] for minor). The proportions of the reported populations with decreasing, stable and increasing admission trends were 80%, 20% and 0% for DFD conditions (50%, 0% and 50% for ulceration; 50%, 17% and 33% for infection; 67%, 0% and 33% for PAD) and 80%, 7% and 13% for amputations (80%, 17% and 3% for major; 52%, 15% and 33% for minor), respectively.These findings suggest that hospital admission rates for all DFD conditions are considerably higher than those for amputations alone and, thus, the more common practice of reporting admission rates only for amputations may substantially underestimate the burden of DFD. While major amputation rates appear to be largely decreasing, this is not the case for hospital admissions for DFD conditions or minor amputation in many populations. However, true global conclusions are limited because of a lack of consistent definitions used to identify admission rates for DFD conditions and amputations, alongside a lack of data from low- and middle-income countries. We recommend that these areas are addressed in future studies.This review was registered in the Open Science Framework database ( https://doi.org/10.17605/OSF.IO/4TZFJ ).

Background: In this celebratory issue ofProsthetics and Orthotics International, we review professional communication skills in the field of prosthetics and orthotics. Objective: We aim to reflect on communication skills in the past 50 years, to discuss developments in the coming 50 years, and to create a toolkit and research agenda to facilitate progress in professional communication in the next 50 years. Results: Despite being a key area in prosthetics and orthotics training programmes, we found no studies on professional communication with an experimental design published inProsthetics and Orthotics International. As an alternative, we provide clinical reflections on the changes in professional communication in the past 50 years, and we discuss questionnaire-based and qualitative studies that provide evidence for the importance of communication in pedorthic footwear provision. In the coming 50 years, professional communication in the field of prosthetics and orthotics may be impacted by aging populations, global mobility, information technology, technological advances and emphasis on prevention. We discuss each of these topics. To facilitate progress in professional communication, we have created a toolkit with resources for prosthetics and orthotics professionals, prosthetics and orthotics students and other interested professionals. Conclusions: We hope this toolkit will inspire others to use, extend and implement it in their daily practice. As a research agenda, we strongly recommend undertaking research on interventions to improve professional communication and to study its effect on clinically meaningful outcomes.

BackgroundIn evaluating the biomechanical properties of therapeutic footwear, most often in-shoe plantar pressure is obtained during mid-gait steps at self-selected speed in a laboratory setting. However, this may not represent plantar pressures or indicate the cumulative stress experienced in daily life, where people adopt different walking speeds and weight-bearing activities.Research questionIn people with diabetes at high risk of ulceration, 1) what is the effect of walking speed on plantar pressure measures, and 2) what is the difference in plantar pressure measures between walking at self-selected speed and other weight-bearing activities?MethodsIn a cross-sectional study, we included 59 feet of 30 participants (5 females, mean age: 63.8 (SD 9.2) years). We assessed in-shoe plantar pressure with the Pedar-X system during three standardized walking speeds (0.8, 0.6 and 0.4 m/s) and eight types of activities versus walking at self-selected speed (3 components of the Timed Up and Go test (TUG), standing, accelerating, decelerating, stair ascending and descending and standing). Peak plantar pressure (PPP) and pressure-time integral (PTI) were determined for the hallux, metatarsal 1, metatarsal 2-3 and metatarsal 4-5. For statistical comparisons we used linear mixed models (αResultsWith increasing walking speed, PPP increased and PTI decreased for all regions (p≤0.001). Standing, decelerating, stair ascending and TUG showed lower PPP than walking at self-selected speed for most regions (p≤0.004), whereas accelerating and stair descending showed similar PPP. Stair ascending and descending showed higher PTI than walking at self-selected speed (p≤0.002), standing showed lower PTI (p≤0.001), while the other activities showed similar PTI for most regions.SignificanceTo best evaluate the biomechanical properties of therapeutic footwear, and to assess cumulative plantar tissue stress of people with diabetes at high risk of ulceration, plantar pressures during different walking speeds and activities of daily living should be considered.

IntroductionTo explore changes in footwear adherence following provision of custom-made indoor footwear in people with diabetes at high risk for plantar foot ulceration and in possession of regular custom-made footwear.Research design and methodsAdherence indoors and outdoors was assessed objectively as percentage of steps custom-made footwear was worn, at baseline (in regular custom-made footwear), and at 1 and 12 months after providing custom-made indoor footwear (in both indoor and regular footwear). Primary group: participants with low (ResultsOf 31 participants, 23 had low baseline indoor adherence (ConclusionsFootwear adherence increased in the short-term and long-term after provision of custom-made indoor footwear in people at high risk of diabetic foot ulceration with low baseline adherence, because they actively wore their newly provided indoor footwear inside their house. Footwear adherence may be helped by using both regular and indoor custom-made footwear in clinical practice; the effect on ulcer recurrence should be investigated in future trials.

OBJECTIVE No study has reported global disability burden estimates for individual diabetes-related lower-extremity complications (DRLECs). The Global Burden of Disease (GBD) study presents a robust opportunity to address this gap. RESEARCH DESIGN AND METHODS GBD 2016 data, including prevalence and years lived with disability (YLDs), for the DRLECs of diabetic neuropathy, foot ulcer, and amputation with and without prosthesis were used. The GBD estimated prevalence using data from systematic reviews and DisMod-MR 2.1, a Bayesian meta-regression tool. YLDs were estimated as the product of prevalence estimates and disability weights for each DRLEC. We reported global and sex-, age-, region-, and country-specific estimates for each DRLEC for 1990 and 2016. RESULTS In 2016, an estimated 131 million people (1.8% of the global population) had DRLECs. An estimated 16.8 million YLDs (2.1% global YLDs) were caused by DRLECs, including 12.9 million (95% uncertainty interval 8.30–18.8) from neuropathy only, 2.5 million (1.7–3.6) from foot ulcers, 1.1 million (0.7–1.4) from amputation without prosthesis, and 0.4 million (0.3–0.5) from amputation with prosthesis. Age-standardized YLD rates of all DRLECs increased by between 14.6% and 31.0% from 1990 estimates. Male-to-female YLD ratios ranged from 0.96 for neuropathy only to 1.93 for foot ulcers. The 50- to 69-year-old age-group accounted for 47.8% of all YLDs from DRLECs. CONCLUSIONS These first-ever global estimates suggest that DRLECs are a large and growing contributor to the disability burden worldwide and disproportionately affect males and middle- to older-aged populations. These findings should facilitate policy makers worldwide to target strategies at populations disproportionately affected by DRLECs.

Monitoring foot skin temperatures at home have been shown to be effective at preventing the occurrence of diabetic foot ulcers. In this study, the construct validity of using >2.2°C difference between contralateral areas on the foot as a warning sign of imminent ulceration is explored. Thirty participants with diabetes at high risk of ulceration (loss of protective sensation and previous ulceration and/or amputation) monitored their foot temperatures at six sites, four times a day for six days using a handheld infrared thermometer. Walking activity, time of day, and environmental temperature were also monitored and correlated with foot temperatures. We found that contralateral mean skin temperature difference was 0.78°C at baseline. At single sites, left-to-right temperature differences exceeding the threshold were found in 9.6% of measurements ( n = 365), which reduced to 0.4% when individually corrected and confirmed the next day. No correlation was found between contralateral temperature differences and activity, time of day, and environmental temperature. We conclude that using a >2.2°C difference is invalid as a single measurement in people at high risk of ulceration, but the construct validity is appropriate if both individual corrections and next day confirmation are applied.

IntroductionDiabetes-related foot disease is a large cause of the global disease burden yet receives very little research funding to address this large burden. To help address this gap, it is recommended to first identify the consensus priority research questions of relevant stakeholders, yet this has not been performed for diabetes-related foot disease. The aim of this study was to determine the national top 10 priority research questions for diabetes-related foot health and disease from relevant Australian stakeholders.Research design and methodsA modified three-round Delphi online survey design was used to seek opinions from relevant Australian stakeholders including those with diabetes or diabetes-related foot disease or their carers (consumers), health professionals, researchers and industry. Participants were recruited via multiple public invitations and invited to propose three research questions of most importance to them (Round 1), prioritize their 10 most important questions from all proposed questions (Round 2), and then rank questions in order of importance (Round 3).ResultsAfter Round 1, a total of 226 unique questions were proposed by 210 participants (including 121 health professionals and 72 consumers). Of those participants, 95 completed Round 2 and 69 completed Round 3. The top 10 priority research questions covered a range of topics, including health economics, peripheral neuropathy, education, infection, technology, exercise, and nutrition. Consumers prioritized peripheral neuropathy and prevention-related questions. Health professionals prioritized management-related questions including Australia’s First Peoples foot health, health economics and infection questions.ConclusionsThese priority research questions should guide future national research agendas, funding and projects to improve diabetes-related foot disease burdens in Australia and globally. Future research should focus on consumer priority research questions to improve the burden of diabetes-related foot disease on patients and nations. Further research should also investigate reasons for different priorities between consumers and health professionals.

Diabetes-related foot ulcers (DFUs) affect around 20 million people annually and are a leading cause of the global disability burden (1). DFUs are complex to treat, take months to heal, result in poorer quality of life, and place patients at high risk of hospitalization and amputation. Thus, understanding the influence that different factors have on healing of DFUs is vital. Various demographic, comorbidity, limb, ulcer, and treatment-related factors associated with healing of DFUs have been identified from cohorts attending mostly metropolitan tertiary centers (2–4). However, very few studies have prospectively investigated the influence that these and other factors have on healing in more real-world DFU cohorts attending geographically diverse secondary and tertiary centers. Therefore, we aimed to investigate the influence of 34 factors on healing in a large real-world DFU cohort. We prospectively examined 4,832 consecutive patients with DFU(s) that presented for their first visit to 1 of 65 secondary or tertiary diabetic foot services, across 15 of 17 regions in Queensland (Australia), between July 2011 and December 2017. A DFU was defined as a full-thickness wound below the ankle on a person with diabetes. For DFU clinical and research purposes, foot-related health professionals using the Queensland High Risk Foot Form (QHRFF) directly examined each patient clinically at their first (and subsequent) visit for 4 demographic, 9 comorbidity, 6 limb, 3 ulcer, and 12 treatment factors (5). For those with multiple DFUs, we used the most severe score for each factor and the combined ulcer size from all DFUs (5). Factors from the first visit were used as the baseline. Subsequent visit examinations determined if the DFU(s) healed, …

Aims\ud To investigate factors independently associated with time-to-(being)-ulcer-free, time-varying effects and predict adjusted ulcer-free probabilities, in a large prospective cohort with diabetes-related foot ulcers (DFU) followed-up for 24 months.\ud Methods\ud Patients presenting with DFU(s) to 65 Diabetic Foot Services across Queensland, Australia, between July-2011 and December-2017 were included. Demographic, comorbidity, limb, ulcer, and treatment factors were captured at presentation. Patients were followed-up until ulcer-free (all DFU(s) healed), amputation, death or two years. Factors associated with time-to-ulcer-free were investigated using both Cox proportional hazards and flexible parametric survival models to explore time-varying effects and plot predicted adjusted ulcer-free probability graphs. \ud Results\ud Of 4,709 included patients (median age 63 years, 69.5% male), median time-to-ulcer-free was 112 days (IQR:40->730), with 68.4% ulcer-free within two years. Factors independently associated with longer time-to-ulcer-free were each year of age younger than 60 years, living in a regional or remote area, smoking, neuropathy, peripheral artery disease (PAD), ulcer size >1cm2, deep ulcer and mild infection (all p

IntroductionThe skin of people with diabetic foot disease is thought to heat up from ambulatory activity before it breaks down into ulceration. This allows for early recognition of imminent ulcers. We assessed whether at-home monitoring of plantar foot skin temperature can help prevent ulcer recurrence in diabetes.Research design and methodsIn this parallel-group outcome-assessor-blinded multicenter randomized controlled trial (7 hospitals, 4 podiatry practices), we randomly assigned people with diabetes, neuropathy, foot ulcer history (2.2°C between corresponding sites on the left and right foot for two consecutive days, participants were instructed to reduce ambulatory activity until this hotspot disappeared and contact their podiatrist. Primary outcome was ulcer recurrence in 18 months on the plantar foot, interdigital, or medial/lateral/anterior forefoot surfaces; secondary outcome was ulcer recurrence at any foot site.ResultsOn the basis of intention-to-treat, 44 of 151 (29.1%) participants in enhanced therapy and 57 of 153 (37.3%) in usual care had ulcer recurrence at a primary outcome site (RR: 0.782 (95%CI 0.566 to 1.080), p=0.133). Of the 83 participants in enhanced therapy who measured a hotspot, the 24 subsequently reducing their ambulatory activity had significantly fewer ulcer recurrences (n=3) than those in usual care (RR: 0.336 (95% CI 0.114 to 0.986), p=0.017). Enhanced therapy was effective over usual care for ulcer recurrence at any foot site (RR: 0.760 (95% CI 0.579 to 0.997), p=0.046).ConclusionsAt-home foot temperature monitoring does not significantly reduce incidence of diabetic foot ulcer recurrence at or adjacent to measurement sites over usual care, unless participants reduce ambulatory activity when hotspots are found, or when aiming to prevent ulcers at any foot site.Trial registration numberNTR5403.

Background Diabetes-related foot ulcers (DFU) take months to heal, reduce patient’s quality-of-life, and induce large healthcare expenditure. Various factors have been identified to influence DFU healing at fixed periods, however, data on factors associated with time-to-healing is scarce. Methods Patients presenting with DFU to Diabetic Foot Services across Queensland, Australia between July 2011 and December 2017 were included and had their demographics, disease history and treatments examined at baseline. Outcome of interest was healing of all ulcers within two-year follow-up time. Time-to-healing and associated factors were examined using flexible parametric survival models, which easily enabled including time-varying coefficients and predicting proportions healed. Results Of 4,709 included patients (median age 63 years, 69.5% male, 10.5% Indigenous), median time-to-healing was 112 days, and 68% healed within two years. Younger age ( Conclusions This study identified novel and confirmatory factors influencing time-to-healing over 24 months in a large real-world cohort of people with diabetes-related foot ulcers. Visualizing the adjusted predicted proportion healed revealed the influence each factor had on healing rates over time. Key messages Flexible parametric survival model provided flexibility in investigating time-varying effects and outcome prediction in those with diabetes-related foot ulcer healing.

Background Implementation of guideline-based care for diabetes-related foot ulcers (DFU) in clinical practice is typically sub-optimal. We aimed to evaluate the cost-effectiveness of implementing different incremental increases in guideline-based care scenarios, compared with current practice, using discrete event simulation models. Methods The costs and effectiveness of current practice (identified as 30% receiving guideline-based care, remainder (70%) non-guideline-based care) were compared with seven hypothetical scenarios of implementing incremental increases in guideline-based care (40%, 50%, 60%, 70%, 80%, 90%, 100%) and evaluated using discrete event simulation models, including important events of disease history and parameterised by a large DFU cohort. Incremental cost-effectiveness ratio for each scenario was calculated and compared to willingness-to-pay of AUD28,000 per quality-adjusted life-years (QALY). Probability sensitivity analysis was conducted to incorporate parameter uncertainty by 2,000 random simulations. Results Under a three-year time-horizon, the seven scenarios (40%-100% guideline-based care) were estimated to incrementally save $901-$1843 (AUD 2020) and provide 0.017-0.056 more QALY per person, with all scenarios being cost-saving & more effective than current practice (30% guideline-based care). From probability sensitivity analyses we were increasingly confident (69.7%-89.8% confident) that implementing increased incremental scenarios (40%-100% guideline-based care) would be cost-effective compared with current practice (59.8%-73.4% confident). Conclusions All scenarios incrementally increasing guideline-based care were evaluated to be cost-saving and more effective than current practice according to this discrete event simulation modelling based on a large real-world cohort. Key messages Our findings support the cost-effectiveness of implementing any incremental increase in guideline-based care compared to current practice.

Diagnosis of peripheral artery disease in people with diabetes and a foot ulcer using current non-invasive blood pressure measurements is challenging. Laser speckle contrast imaging (LSCI) is a promising non-invasive technique to measure cutaneous microcirculation. This study investigated the association between microcirculation (measured with both LSCI and non-invasive blood pressure measurement) and healing of diabetic foot ulcers 12 and 26 weeks after measurement. We included sixty-one patients with a diabetic foot ulcer in this prospective, single-center, observational cohort-study. LSCI scans of the foot, ulcer, and ulcer edge were conducted, during baseline and post-occlusion hyperemia. Non-invasive blood pressure measurement included arm, foot, and toe pressures and associated indices. Healing was defined as complete re-epithelialization and scored at 12 and 26 weeks. We found no significant difference between patients with healed or non-healed foot ulcers for both types of measurements (p = 0.135–0.989). ROC curves demonstrated moderate sensitivity (range of 0.636–0.971) and specificity (range of 0.464–0.889), for LSCI and non-invasive blood pressure measurements. Therefore, no association between diabetic foot ulcer healing and LSCI-measured microcirculation or non-invasive blood pressure measurements was found. The healing tendency of diabetic foot ulcers is difficult to predict based on single measurements using current blood pressure measurements or LSCI.

IntroductionWe aimed to develop a prediction model for foot ulcer recurrence in people with diabetes using easy-to-obtain clinical variables and to validate its predictive performance in order to help risk assessment in this high-risk group.Research design and methodsWe used data from a prospective analysis of 304 people with foot ulcer history who had 18-month follow-up for ulcer outcome. Demographic, disease-related and organization-of-care variables were included as potential predictors. Two logistic regression prediction models were created: model 1 for all recurrent foot ulcers (n=126 events) and model 2 for recurrent plantar foot ulcers (n=70 events). We used 10-fold cross-validation, each including five multiple imputation sets for internal validation. Performance was assessed in terms of discrimination using area under the receiver operating characteristic curve (AUC) (0–1, 1=perfect discrimination), and calibration with the Brier Score (0–1, 0=complete concordance predicted vs observed values) and calibration graphs.ResultsPredictors in model 1 were: a younger age, more severe peripheral sensory neuropathy, fewer months since healing of previous ulcer, presence of a minor lesion, use of a walking aid and not monitoring foot temperatures at home. Mean AUC for model 1 was 0.69 (2SD 0.040) and mean Brier Score was 0.22 (2SD 0.011). Predictors in model 2 were: a younger age, plantar location of previous ulcer, fewer months since healing of previous ulcer, presence of a minor lesion, consumption of alcohol, use of a walking aid, and foot care received in a university medical center. Mean AUC for model 2 was 0.66 (2SD 0.023) and mean Brier Score was 0.16 (2SD 0.0048).ConclusionsThese internally validated prediction models predict with reasonable to good calibration and fair discrimination who is at highest risk of ulcer recurrence. The people at highest risk should be monitored more carefully and treated more intensively than others.Trial registration numberNTR5403.

Introduction: The skin of people with diabetic foot disease is thought to heat up from ambulatory activity before it breaks down into ulceration. We assessed cost-effectiveness and cost-utility of at-home foot skin temperature monitoring for ulcer prevention in people with diabetes. Methods: In this outcome-assessor-blinded multicenter RCT, we randomly assigned people with diabetes, neuropathy, foot ulcer history or Charcot’s neuro-arthropathy to usual care (i.e., podiatric treatment, education, and therapeutic footwear) or usual care plus measuring skin temperatures at 6-8 plantar sites per foot each day (enhanced therapy). Foot care costs from a societal perspective were obtained via institute for Medical Technology Assessment questionnaires and from health records. Utilities were calculated based on health-related quality of life as assessed with the EQ-5D-3L. Primary clinical outcome for effectiveness was foot ulcer recurrence. Group differences were assessed by calculating 95% confidence intervals after correction for bias and using accelerated non-parametric bootstrapping. Results: Total foot care costs per participant during 18-months follow-up were significantly lower in the intervention group (n=151; €4007 (SD: €6349)) compared to usual care (n=153; €6872 (SD: 15251); p=0.033). The intervention had 99.3% probability of being cost-effective at a willingness-to-pay of €50,000. Quality-adjusted life years were lower in the intervention group (1.09 (SD: 0.35)) than in usual care (1.12 (SD: 0.34); p=0.397). The intervention had 69.0% probability of achieving cost-utility at a willingness-to-pay of €50,000. Conclusion: In this first-ever societal-perspective cost-effectiveness RCT in the field of diabetic foot disease, we found at-home foot skin temperature monitoring a cost-effective intervention in foot ulcer prevention, at the expense of lower quality of life. Disclosure J. Van netten: None. W. B. Aan de stegge: None. M. Dijkgraaf: None. S. A. Bus: None. Funding Netherlands Organization for Health Research and Development (837002508); Dutch Society for Podiatrists; Dutch Branch Organization for Pedicures

Excessive stress on plantar tissue over time is one of the leading causes of diabetic foot ulcers among people with diabetic peripheral neuropathy. Plantar tissue stress (PTS) is a concept that attempts to integrate several well-known mechanical factors into one measure, including plantar pressure, shear stress, daily weight-bearing activity, and time spent in prescribed offloading interventions (adherence). Despite international diabetic foot guidelines recommending the measure of each of these individual mechanical factors in people with neuropathy, only recently has technology enabled their combined measurement to determine PTS. In this article we review the concept of PTS, the mechanical factors involved, and the findings of pivotal articles reporting measures of PTS in people with neuropathy. We also discuss key existing gaps in this field, including the lack of standards to measure and report PTS, a lack of practical solutions to measure shear stress, and the lack of PTS thresholds that may indicate benefit or detriment to people with neuropathy. To address some of these gaps, we propose recommended clinical and research standards for measuring and reporting PTS in people with neuropathy. Last, we forecast future clinical, research, and technological advancements that may use PTS to highlight the importance of this critical concept in the prevention and management of diabetic foot ulcers.

Background: Thermal assessment of the plantar surface of the foot using spot thermometers and thermal imaging has been proven effective in diabetic foot ulcer prevention. However, with traditional cameras this is limited to single spots or a two-dimensional (2D) view of the plantar side of foot, where only 50% of the ulcers occur. To improve ulcer detection, the view has to be extended beyond 2D. Our aim is to explore for proof of concept the combination of three-dimensional (3D) models with thermal imaging for inflammation detection in diabetic foot disease. Method: From eight participants with a current diabetic foot ulcer we simultaneously acquired a 3D foot model and three thermal infrared images using a high-resolution medical 3D imaging system aligned with three smartphone-based thermal infrared cameras. Using spatial transformations, we aimed to map thermal images onto the 3D model, to create the 3D visualizations. Expert clinicians assessed these for quality and face validity as +, +/-, -. Results: We could replace the texture maps (color definitions) of the 3D model with the thermal infrared images and created the first-ever 3D thermographs of the diabetic foot. We then converted these models to 3D PDF-files compatible with the hospital IT environment. Face validity was assessed as + in six and +/- in two cases. Conclusions: We have provided a proof of concept for the creation of clinically useful 3D thermal foot images to assess the diabetic foot skin temperature in 3D in a hospital IT environment. Future developments are expected to improve the image-processing techniques to result in easier, handheld applications and driving further research.

Diabetes presents significant self-care challenges that require sustained motivation. Motivational Interviewing (MI) has substantial support in enhancing motivation for behavioural change, but its effective application in routine healthcare requires practitioners to acquire and use related skills. The aim of this systematic review was to investigate the impact of MI training on MI-related skills of practitioners who provide diabetes healthcare. PubMed, EMBASE and PsycINFO were searched using the terms motivational interviewing, motivation enhancement, and diabetes. Two assessors independently screened titles, abstracts and full texts for papers reporting the impact of MI training on diabetes healthcare practitioners’ outcomes. Of 625 abstracts screened, 22 papers from 17 unique studies were included. All 17 studies reported some improvement in MI skills, with 14 finding improvements in more than 50% and three less than 35%. However, the risk of bias and outcome measures varied widely between studies. All studies showed diabetes healthcare practitioners acquired and applied MI skills post-training, to varying levels. Findings suggest training should include education, role play, and ongoing supervision to maintain skills.

Background: Gait symmetry is used to measure pathological gait but is usually applied to unilateral pathology. This study aims to investigate bilateral impairment using existing and new gait symmetry methods. Methods: 15 healthy volunteers and 14 people with diabetes and distal symmetrical polyneuropathy participated in this study. Three temporal parameters (combined step, stance phase and double stance), expressed as a percentage, were extracted for comparing gait symmetry between healthy volunteers and patients using in-shoe measurements (Pedar-X). Three indices were calculated, including the widely used Symmetry Index; the well-established Variability Index; and the newly developed Laterality Index, that calculates how well distributed a condition is across both legs. Findings: In all three parameters, Symmetry and Variability Index proved to be significantly greater in the diabetic cohort (p-values range < 0.001–0.0226). The Laterality Index was significantly greater in the diabetic cohort for the stance and double stance phases (p-values 0.03 and < 0.001), but not for the combined step (p-value 0.3953). In both cohorts, Laterality Index