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

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

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

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

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

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

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.

Body image profiles combining body shame, body appreciation and body mass index differentiate dietary restraint and exercise amount in women.

This project aimed to establish whether meaningful body image profiles (BIPs) could be identified across measures of body shame, body appreciation, and body mass index (BMI), and whether these profiles could differentiate key health behaviours. Data came from 1200 adult women who responded to an online body image survey. Latent profile analysis was used to identify BIPs based on relative levels of body shame, body appreciation and BMI. Differences in dietary restraint and weekly exercise amount were investigated according to BIP membership. Latent profile analysis revealed four unique BIPs; 1. Appreciative BIP (AP-BIP); 2. Medium Shame BIP (MS-BIP); 3. High Shame BIP (HS-BIP) and 4. Average BIP (AV-BIP). Dietary restraint and exercise amount differed significantly according to BIP in most comparisons. Women in the High Shame BIP exhibited the highest dietary restraint and lowest exercise. Women in the Appreciative BIP exhibited the lowest dietary restraint and highest exercise. Body shame and body appreciation intersect with BMI to form unique profiles (BIPs) that differentiate dietary restraint and exercise. Using BIPs to tailor interventions designed to promote healthful diet and exercise should be considered in public health initiatives.

Offloading effects of a removable cast walker with and without modification for diabetes-related foot ulceration: a plantar pressure study.

BACKGROUND: Removable cast walkers (RCWs), with or without modifications, are used to offload diabetes-related foot ulcers (DRFUs), however there is limited data relating to their offloading effects. This study aimed to quantify plantar pressure reductions with an RCW with and without modification for DRFUs. METHODS: This within-participant, repeated measures study included 16 participants with plantar neuropathic DRFUs. Walking peak plantar pressures at DRFU sites were measured for four conditions: post-operative boot (control condition), RCW alone, RCW with 20 mm of felt adhered to an orthosis, and RCW with 20 mm of felt adhered to the foot. RESULTS: Compared to the control condition, the greatest amount of peak plantar pressure reduction occurred with the RCW with felt adhered to the foot (83.1% reduction, p < .001). The RCW with felt adhered to the foot also offered greater peak plantar pressure reduction than the RCW alone (51.3%, p = .021) and the RCW with felt adhered to an orthosis (31.4%, p = .009). CONCLUSION: The largest offloading effect recorded was with the RCW with felt adhered to the foot. High-quality randomised trials are now needed to evaluate the effectiveness of this device for healing DRFUs.

Australian guideline on prevention of foot ulceration: part of the 2021 Australian evidence-based guidelines for diabetes-related foot disease.

BACKGROUND: There are no current Australian guidelines on the prevention of diabetes-related foot ulceration (DFU). A national expert panel aimed to systematically identify and adapt suitable international guidelines to the Australian context to create new Australian evidence-based guidelines on prevention of first-ever and/or recurrent DFU. These guidelines will include for the first-time considerations for rural and remote, and Aboriginal and Torres Strait Islander peoples. METHODS: The National Health and Medical Research Council procedures were followed to adapt suitable international guidelines on DFU prevention to the Australian health context. This included a search of public databases after which the International Working Group on the Diabetic Foot (IWGDF) prevention guideline was deemed the most appropriate for adaptation. The 16 IWGDF prevention recommendations were assessed using the ADAPTE and GRADE systems to decide if they should be adopted, adapted or excluded for the new Australian guideline. The quality of evidence and strength of recommendation ratings were re-evaluated with reference to the Australian context. This guideline underwent public consultation, further revision, and approval by national peak bodies. RESULTS: Of the 16 original IWGDF prevention recommendations, nine were adopted, six were adapted and one was excluded. It is recommended that all people at increased risk of DFU are assessed at intervals corresponding to the IWGDF risk ratings. For those at increased risk, structured education about appropriate foot protection, inspection, footwear, weight-bearing activities, and foot self-care is recommended. Prescription of orthotic interventions and/or medical grade footwear, providing integrated foot care, and self-monitoring of foot skin temperatures (contingent on validated, user-friendly and affordable systems becoming available in Australia) may also assist in preventing DFU. If the above recommended non-surgical treatment fails, the use of various surgical interventions for the prevention of DFU can be considered. CONCLUSIONS: This new Australian evidence-based guideline on prevention of DFU, endorsed by 10 national peak bodies, provides specific recommendations for relevant health professionals and consumers in the Australian context to prevent DFU. Following these recommendations should achieve better DFU prevention outcomes in Australia.

Guidelines development protocol and findings: part of the 2021 Australian evidence-based guidelines for diabetes-related foot disease.

BACKGROUND: Diabetes-related foot disease (DFD) is a leading cause of the Australian disease burden. The 2011 Australian DFD guidelines were outdated. We aimed to develop methodology for systematically adapting suitable international guidelines to the Australian context to become the new Australian evidence-based guidelines for DFD. METHODS: We followed the Australian National Health Medical Research Council (NHMRC) guidelines for adapting guidelines. We systematically searched for all international DFD guideline records. All identified records were independently screened and assessed for eligibility. Those deemed eligible were further assessed and included if scoring at least moderate quality, suitability and currency using AGREE II and NHMRC instruments. The included international guidelines had all recommendations extracted into six sub-fields: prevention, wound classification, peripheral artery disease, infection, offloading and wound healing. Six national panels, each comprising 6-8 multidisciplinary national experts, screened all recommendations within their sub-field for acceptability and applicability in Australia using an ADAPTE form. Where panels were unsure of any acceptability and applicability items, full assessments were undertaken using a GRADE Evidence to Decision tool. Recommendations were adopted, adapted, or excluded, based on the agreement between the panel's and international guideline's judgements. Each panel drafted a guideline that included all their recommendations, rationale, justifications, and implementation considerations. All underwent public consultation, final revision, and approval by national peak bodies. RESULTS: We screened 182 identified records, assessed 24 full text records, and after further quality, suitability, and currency assessment, one record was deemed a suitable international guideline, the International Working Group Diabetic Foot Guidelines (IWGDF guidelines). The six panels collectively assessed 100 IWGDF recommendations, with 71 being adopted, 27 adapted, and two excluded for the Australian context. We received 47 public consultation responses with > 80% (strongly) agreeing that the guidelines should be approved, and ten national peak bodies endorsed the final six guidelines. The six guidelines and this protocol can be found at: https://www.diabetesfeetaustralia.org/new-guidelines/ CONCLUSION: New Australian evidence-based guidelines for DFD have been developed for the first time in a decade by adapting suitable international guidelines. The methodology developed for adaptation may be useful for other foot-related conditions. These new guidelines will now serve as the national multidisciplinary best practice standards of DFD care in Australia.

Body image profiles and exercise behaviours in early motherhood. A latent profile analysis.

Early motherhood may impact body image, and its relationship to exercise, potentially affecting mother and infant wellbeing. This study examined whether duration of weekly exercise differed according to body image profile (BIP) based on relative levels of body dissatisfaction and body appreciation. Survey data from 262 women, 0-5 years postpartum, were analysed. Latent profile analysis identified "average", "dissatisfied" and "appreciative" BIPs. Significantly lower exercise was found in the dissatisfied compared to the appreciative BIP (p = 0.005), with marginally lower exercise in the dissatisfied compared to the average BIP (p = 0.029 with adjusted α = 0.02). This research has implications for designing targeted interventions supporting postpartum wellbeing.

Establishing the national top 10 priority research questions to improve diabetes-related foot health and disease: a Delphi study of Australian stakeholders.

INTRODUCTION: Diabetes-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 METHODS: A 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). RESULTS: After 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. CONCLUSIONS: These 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.

Mothers' experiences of the relationship between body image and exercise, 0-5 years postpartum: A qualitative study.

The relationship between body image and exercise in early motherhood is an important yet understudied determinant of mother and infant wellbeing. To address this, we report on a qualitative study of early mothers' lived experiences of the relationship between body image and exercise in the first five years post-birth. Twenty-one mothers (0-5 years postpartum) completed individual, semi-structured online/phone interviews (M interview time =47.25 min), to elicit narratives about peripartum body image and its relationship with exercise. Thematic analysis was conducted according to the Braun and Clarke framework. Three key themes, and several subthemes, were identified: 1.body image in early motherhood is diverse, dynamic and individual, 2.postpartum exercise forms part of early motherhood adjustment, and 3.body image and exercise form an important, intricate relationship in early motherhood. Women's narratives indicated three body image/exercise patterns, each characterised by different behaviours and motivations. Mothers who reported exercising, or avoiding exercising, for reasons related to body dissatisfaction appeared at greatest risk of negative outcomes from body-related distress and maladaptive exercise patterns. Conversely, mothers reporting higher body appreciation described more adaptive exercise behaviours. This research provides important information for the development of interventions to support positive body image and healthful exercise in early motherhood.

Guidelines on the prevention of foot ulcers in persons with diabetes (IWGDF 2019 update).

The International Working Group on the Diabetic Foot (IWGDF) has published evidence-based guidelines on the prevention and management of diabetic foot disease since 1999. This guideline is on the prevention of foot ulceration in persons with diabetes and updates the 2015 IWGDF prevention guideline. We followed the GRADE methodology to devise clinical questions and critically important outcomes in the PICO format, to conduct a systematic review of the medical-scientific literature, and to write recommendations and their rationale. The recommendations are based on the quality of evidence found in the systematic review, expert opinion where evidence was not available, and a weighing of the benefits and harms, patient preferences, feasibility and applicability, and costs related to the intervention. We recommend to screen a person at very low risk for ulceration annually for loss of protective sensation and peripheral artery disease and persons at higher risk at higher frequencies for additional risk factors. For preventing a foot ulcer, educate the at-risk patient about appropriate foot self-care and treat any pre-ulcerative sign on the foot. Instruct moderate-to-high risk patients to wear accommodative properly fitting therapeutic footwear, and consider instructing them to monitor foot skin temperature. Prescribe therapeutic footwear that has a demonstrated plantar pressure relieving effect during walking to prevent plantar foot ulcer recurrence. In patients that fail non-surgical treatment for an active or imminent ulcer, consider surgical intervention; we suggest not to use a nerve decompression procedure. Provide integrated foot care for high-risk patients to prevent ulcer recurrence. Following these recommendations will help health care professionals to provide better care for persons with diabetes at risk of foot ulceration, to increase the number of ulcer-free days, and to reduce the patient and health care burden of diabetic foot disease.

Prevention of foot ulcers in the at-risk patient with diabetes: a systematic review.

Prevention of foot ulcers in patients with diabetes is important to help reduce the substantial burden on both patient and health resources. A comprehensive analysis of reported interventions is needed to better inform healthcare professionals about effective prevention. The aim of this systematic review is to investigate the effectiveness of interventions to help prevent both first and recurrent foot ulcers in persons with diabetes who are at risk for this complication. We searched the available medical scientific literature in PubMed, EMBASE, CINAHL, and the Cochrane databases for original research studies on preventative interventions. We screened trial registries for additional studies not found in our search and unpublished trials. Two independent reviewers assessed data from controlled studies for methodological quality, and extracted and presented this in evidence and risk of bias tables. From the 13,490 records screened, 35 controlled studies and 46 non-controlled studies were included. Few controlled studies, which were of generally low to moderate quality, were identified on the prevention of a first foot ulcer. For the prevention of recurrent plantar foot ulcers, there is benefit for the use of daily foot skin temperature measurements, and for therapeutic footwear with demonstrated plantar pressure relief, provided it is consistently worn by the patient. For prevention of ulcer recurrence, there is some evidence for providing integrated foot care, and no evidence for a single session of education.Surgical interventions have been shown effective in selected patients, but the evidence base is small. Foot-related exercises do not appear to prevent a first foot ulcer. A small increase in the level of weight-bearing daily activities does not seem to increase the risk for foot ulceration. The evidence base to support the use of specific self-management and footwear interventions for the prevention of recurrent plantar foot ulcers is quite strong. The evidence is weak for the use of other, sometimes widely applied, interventions, and is practically non-existent for the prevention of a first foot ulcer and non-plantar foot ulcer.

Treatment of modifiable risk factors for foot ulceration in persons with diabetes: a systematic review.

BACKGROUND: Prevention of diabetic foot ulcers is important. Preventative treatment mostly targets and aims to improve modifiable risk factors of foot ulceration. While effectiveness of interventions in ulcer prevention has been systematically reviewed, their effectiveness in improving modifiable risk factors is unknown. METHODS: The available medical scientific literature in PubMed, Excerpta Medica Database, and the Cochrane database was searched for original research studies on six interventions to treat modifiable risk factors for diabetic foot ulceration (ie, education for patients; education for professionals; self-management; pre-ulcer treatment; orthotic interventions; and foot- and mobility-related exercises). We assessed interventions for eight outcomes (ie, patients' knowledge; treatment adherence; professionals' knowledge; pre-ulcers; mechanical stress; neuropathy symptoms; foot/ankle joint mobility; and foot function). Both controlled and noncontrolled studies were selected. Data from controlled studies were assessed for methodological quality by two independent reviewers and extracted and presented in evidence and risk of bias tables. RESULTS: We included 72 publications (26 with a controlled study design and 46 noncontrolled). We found that structured education may improve foot self-care behaviour of patients, yearly foot examinations, and foot disease knowledge of health care professionals. Callus removal reduces peak plantar pressure. Custom-made therapeutic footwear can be effective in reducing plantar pressure and may reduce callus. Foot- and mobility-related exercises may improve neuropathy symptoms and foot and ankle joint range of motion, while they do not seem to reduce peak plantar pressure; evidence for their effect on foot strength is conflicting. CONCLUSIONS: Structured education for patients and health care professionals, callus removal, custom-made therapeutic footwear, and foot- and mobility-related exercises may be beneficial for improving modifiable risk factors for foot ulceration. However, we generally found low quality of evidence for interventions targeting modifiable risk factors for ulceration in persons with diabetes, with frequently inconsistent or limited results available per intervention and outcome.

Risk factors for foot ulceration in adults with end-stage renal disease on dialysis: a prospective observational cohort study.

BACKGROUND: Dialysis patients experience high rates of foot ulceration. Although risk factors for ulceration have been extensively studied in patients with diabetes, there is limited high-quality, longitudinal evidence in the dialysis population. Therefore, this study investigated risk factors for foot ulceration in a stable dialysis cohort. METHODS: We prospectively collected clinical, demographic, health status, and foot examination information on 450 adults with end-stage renal disease from satellite and home-therapy dialysis units in Melbourne, Australia over 12 months. The primary outcome was foot ulceration. Cox proportional hazard modelling and multinomial regression were used to investigate risk factors. RESULTS: Among 450 dialysis patients (mean age, 67.5 years; 64.7% male; 94% hemodialysis; 50.2% diabetes), new cases of foot ulceration were identified in 81 (18%) participants. Overall, risk factors for foot ulceration were neuropathy (HR 3.02; 95% CI 1.48 to 6.15) and previous ulceration (HR 2.86; CI 1.53 to 5.34). In those without history of ulceration, nail pathology (RR 3.85; CI 1.08 to 13.75) and neuropathy (RR 2.66; CI 1.04 to 6.82) were risk factors. In those with history of ulceration, neuropathy (RR 11.23; CI 3.16 to 39.87), peripheral arterial disease (RR 7.15; CI 2.24 to 22.82) and cerebrovascular disease (RR 2.08; CI 1.04 to 4.16) were risk factors. There were 12 (2.7%) new amputations, 96 (21.3%) infections, 24 (5.3%) revascularizations, 42 (9.3%) foot-related hospitalizations, and 52 (11.6%) deaths. CONCLUSIONS: Neuropathy and previous ulceration are major risk factors for foot ulceration in dialysis patients. Risk factors differ between those with and without prior ulceration. The risk factors identified will help to reduce the incidence of ulceration and its associated complications.

Factors associated with foot ulceration and amputation in adults on dialysis: a cross-sectional observational study.

BACKGROUND: Adults on dialysis are at increased risk of foot ulceration, which commonly precedes more serious lower limb complications, including amputation. Limited data exist regarding the prevalence and factors associated with foot disease in this population. Hence, this study set out to investigate factors associated with foot ulceration and amputation in a dialysis cohort. METHODS: This study presents a cross-sectional analysis of baseline data from a multi-center prospective cohort study. We recruited 450 adults with end-stage renal disease on dialysis from multiple satellite and home-therapy dialysis units in Melbourne, Australia from January to December 2014. Data collection consisted of a participant interview, medical record review, health-status questionnaire and non-invasive foot examination. Logistic regression analyses were conducted to evaluate associations between screened variables and study outcomes. RESULTS: Mean age was 67.5 (SD, 13.2) years, 64.7% were male, 94% were on hemodialysis, median dialysis duration was 36.9 (IQR, 16.6 to 70.1) months, and 50.2% had diabetes. There was a high prevalence of previous ulceration (21.6%) and amputation (10.2%), 10% had current foot ulceration, and 50% had neuropathy and/or peripheral arterial disease. Factors associated with foot ulceration were previous amputation (OR, 10.19), peripheral arterial disease (OR, 6.16) and serum albumin (OR, 0.87); whereas previous and/or current ulceration (OR, 167.24 and 7.49, respectively) and foot deformity (OR, 15.28) were associated with amputation. CONCLUSIONS: Dialysis patients have a high burden of lower limb complications. There are markedly higher risks of foot ulceration and/or amputation in those with previous and/or current ulceration, previous amputation, peripheral arterial disease, lower serum albumin, and foot deformity. Although not a major risk factor, diabetes in men was an important effect modifier for risk of ulceration.

The effectiveness of felt padding for offloading diabetes-related foot ulcers, at baseline and after one week of wear.

AIM: Felt padding is used to offload diabetes-related foot ulceration although limited quality data exists to support its use. This study aimed to quantify pressure offloading from neuropathic plantar foot ulcers in a clinical setting, when felt padding is first applied and after wear. METHODS: This study used a within-subjects, repeated measures design. Data was collected in a high-risk foot service. Peak plantar pressures, contact area and contact time were measured in 15 diabetes subjects with 16 non-complicated plantar neuropathic foot ulcers, with: no felt padding, newly applied felt padding and felt padding after one week of wear. RESULTS: Statistically significant decreases in peak pressure of 49% and 32% were measured with newly applied felt padding (188.0kPa; p<0.001) and worn felt padding (248kPa; p=0.003) respectively, compared to no padding (367.2kPa). Worn felt offloaded 32% less pressure than new felt however this did not reach statistical significance (p=.069). Corresponding increases in contact area of 18% and 14% occurred with newly applied felt padding (156.9cm2; p<.001) and worn felt padding (150.6cm2; p=0.003) compared to no padding (132.5cm2). Contact time was constant across testing conditions. CONCLUSIONS: New felt padding offloaded on average half the pressure applied to sites of plantar neuropathic ulceration, which reduced to one third after wear. Increased contact area under the foot is a possible mechanism contributing to pressure reduction. Further studies are required to evaluate effectiveness of felt padding directly on ulcer healing.

Risk factors for foot ulceration in adults with end-stage renal disease on dialysis: study protocol for a prospective observational cohort study.

BACKGROUND: Adults with end-stage renal disease treated with dialysis experience a high burden of foot ulceration and lower extremity amputation. However, the risk factors for foot ulceration in the dialysis population are incompletely understood due to the lack of high-quality prospective evidence. This article outlines the design of a prospective observational cohort study, which aims to investigate the risk factors for foot ulceration in adults on dialysis. METHODS/DESIGN: This study will recruit 430 participants with end-stage renal disease on dialysis from satellite and home-therapy dialysis units across multiple health organisations in Melbourne, Victoria, Australia. Data collection at baseline will include a participant interview, medical record review, completion of a health-status questionnaire and a non-invasive foot assessment. Twenty participants will also be recruited to a reliability study to evaluate the reproducibility of testing procedures. Primary outcome data includes: new foot ulcer(s). Secondary outcome data includes: number of new foot ulcers, time to onset of new foot ulcer(s), new lower extremity amputation(s), episodes of infection of the foot or lower extremity, episodes of osteomyelitis, foot-related hospitalisations, revascularisation procedure(s) of the lower extremity, new podiatry interventions, kidney transplantation, and mortality. Participants will be assessed at baseline, and at 12 months they will be evaluated for the primary and secondary outcomes. Multivariate Cox proportional hazards models will be used to assess predictors of new foot ulceration and time to event secondary outcomes. Logistic regression will be used for binary outcomes including prevalence of foot ulcerations. DISCUSSION: This is the first multi-centre prospective observational cohort study to investigate risk factors for foot ulceration in adults with end-stage renal disease on dialysis. This study will improve on prior studies by using prospective methods, multi-centre recruitment, statistical methods to control for confounding variables, and a pre-specified sample size estimation. The findings can inform the design of future trials evaluating the effectiveness of clinical interventions, which may lead to improved patient outcomes in the dialysis setting.

Risk factors for foot ulceration and lower extremity amputation in adults with end-stage renal disease on dialysis: a systematic review and meta-analysis.

BACKGROUND: Adults with end-stage renal disease are at increased risk of foot ulceration and lower extremity amputation. However, the central determinants of lower limb injury and loss are incompletely understood. METHODS: We conducted a systematic review of non-randomized studies that quantified the major risk factors for foot ulceration and amputation in adults treated with dialysis and analysed patient populations in which risks were greatest. Random-effects meta-analysis was used to generate summary estimates. RESULTS: Thirty studies (48 566 participants) were identified. Risk factors for foot ulceration and amputation included previous foot ulceration (odds ratios, OR, 17.56 and 70.13), peripheral arterial disease (OR, 7.52 and 9.12), diabetes (OR, 3.76 and 7.48), peripheral neuropathy (OR, 3.24 and 3.36) and coronary artery disease (OR, 3.92 and 2.49). Participants with foot ulceration or amputation had experienced a longer duration of diabetes (mean difference, MD, 4.04 and 6.07 years) and had lower serum albumin levels (MD, -0.23 and -0.13 g/dL). Risk factors for foot ulceration also included retinopathy (OR, 3.03), previous amputation (OR, 15.50) and higher serum phosphorus levels (MD, 0.40 mg/dL), while risk factors for amputation also included male sex (OR, 1.50), current smoking (OR, 2.26) and higher glycated haemoglobin levels (MD, 0.75%). CONCLUSIONS: Dialysis patients who have markedly higher risks of ulceration or amputation include those with previous foot ulceration or amputation, peripheral neuropathy, diabetes or macrovascular disease. The temporal relationship between these risk factors and the development of foot ulceration and/or limb loss is uncertain and requires further study. Stable estimates of the key risk factors for ulceration and amputation can inform the design of future trials investigating clinical interventions to reduce the burden of lower limb disease in the dialysis population.

Effects of shoe sole hardness on plantar pressure and comfort in older people with forefoot pain.

Plantar forefoot pain is common in older people and is related to increased peak pressures under the foot during gait. Variations in the hardness of the shoe sole may therefore influence both the magnitude of loading under the foot and the perceived comfort of the shoe in this population. The aim of this investigation was to determine the effect of varying shoe sole hardness on plantar pressures and comfort in older people with forefoot pain. In-shoe plantar pressures under the forefoot, midfoot and rearfoot were recorded from 35 older people (mean age 73.2, SD 4.5 years) with current or previous forefoot pain using the pedar-X(®) system. Participants walked at their normal comfortable speed along an 8m walkway in shoes with three different levels of sole hardness: soft (Shore A25), medium (Shore A40) and hard (Shore A58). Shoe comfort was measured on a 100mm visual analogue scale. There were statistically significant differences in peak pressure of between 5% and 23% across the forefoot, midfoot and rearfoot (p<0.01). The hard-soled shoe registered the highest peak pressures and the soft-soled shoe the lowest peak pressures. However, no differences in comfort scores across the three shoe conditions were observed. These findings demonstrate that as shoe sole hardness increases, plantar pressure increases, however this does not appear to have a significant effect on shoe comfort.