Off-loading and compression therapy strategies to treat diabetic foot ulcers complicated by lower limb oedema: a scoping review.

BACKGROUND: Lower limb oedema is a common co-morbidity in those with diabetes and foot ulceration and is linked with increased amputation risk. There is no current guidance for the treatment of concurrent diabetic foot ulcers and lower limb oedema, leading to uncertainty around the safety and efficacy of combination approaches incorporating offloading and compression therapies. To determine indications and contraindications for such strategies and identify any other supplementary treatment approaches, a scoping review was undertaken to map the evidence relating to off-loading and compression therapy strategies to treat both diabetic foot ulcers and lower limb oedema in combination. METHODS: Following the Joanna Briggs Institute (JBI) and PRISMA - Scoping Review (ScR) guidance, this review included published and unpublished literature from inception to April 2022. Literature was sourced using electronic databases including Cochrane Library, PubMed, CINAHL, AMED; websites; professional journals and reference lists of included literature. Eligible literature discussed the management of both diabetic foot ulceration and lower limb oedema and included at least one of the treatment strategies of interest. Data extraction involved recording any suggested off-loading, compression therapy or supplementary treatment strategies and any suggested indications, contraindications and cautions for their use. RESULTS: Five hundred twenty-two publications were found relating to the management of diabetic foot ulcers with an off-loading strategy or the management of lower limb oedema with compression therapy. 51 publications were eligible for inclusion in the review. The majority of the excluded publications did not discuss the situation where diabetic foot ulceration and lower limb oedema present concurrently. CONCLUSIONS: Most literature, focused on oedema management with compression therapy to conclude that compression therapy should be avoided in the presence of severe peripheral arterial disease. Less literature was found regarding off-loading strategies, but it was recommended that knee-high devices should be used with caution when off-loading diabetic foot ulcers in those with lower limb oedema. Treatment options to manage both conditions concurrently was identified as a research gap. Integrated working between specialist healthcare teams, was the supplementary strategy most frequently recommended. In the absence of a definitive treatment solution, clinicians are encouraged to use clinical reasoning along with support from specialist peers to establish the best, individualised treatment approach for their patients. TRIAL REGISTRATION: Open Science Framework (osf.io/crb78).

Insoles to ease plantar pressure in people with diabetes and peripheral neuropathy: a feasibility randomised controlled trial with an embedded qualitative study.

BACKGROUND: Therapeutic footwear and insoles are preventative strategies to reduce elevated plantar pressures associated with diabetic foot ulcer risk. An insole intervention appropriate for chairside delivery optimising plantar foot pressure reduction in people with diabetes has been developed. AIM: To explore the feasibility and acceptability of testing an optimised insole compared with an active control insole to reduce plantar pressures for people with diabetic peripheral neuropathy. METHODS: A double-blinded multi-centre feasibility RCT with an embedded qualitative study. Participants were randomised to either an optimised insole group (intervention) or a standard cushioned insole group (active control). Participants were assessed at baseline, 3, 6, and 12 months with clinical outcomes of foot ulceration and mean peak plantar pressure (MPPP) reduction. An embedded qualitative study involved semi-structured interviews with 12 study participants and three podiatrists to explore their experiences of the intervention and trial procedures. Data were analysed using descriptive statistics (quantitative data) and thematic analysis (qualitative data). RESULTS: Screened were142 patients from which 61 were recruited; 30 participants were randomised to the intervention group and 31 to the active control group. Forty-two participants completed the study. At 12 months, 69% of the patient-reported questionnaires were returned and 68% of the clinical outcomes were collected. There were 17 incidences of foot ulceration occurring in 7/31 of the active control group and 10/30 in the intervention group. Mean difference in MPPP between the intervention and active control groups for all regions-of-interest combined favoured the intervention. Thematic analysis revealed three themes; accepting the study, behaviour and support during study procedures, and impact from study participation. CONCLUSION: The results of the feasibility RCT suggest that the optimised insole holds promise as an intervention, and that a full RCT to evaluate the clinical and cost-effectiveness of this intervention is feasible and warranted for people with diabetic peripheral neuropathy. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number: ISRCTN16011830 . Registered 9th October 2017.

Prevalence and incidence of mental health issues amongst adults with diabetes at risk of foot complications in the European Union: a systematic review protocol.

OBJECTIVE: The objective of this systematic review is to evaluate and synthesize the evidence to establish the prevalence and incidence of mental health issues in people at risk of diabetic foot ulceration living within the European Union. INTRODUCTION: Due to the large health and financial burden of diabetic foot ulceration, prevention is a key focus for clinicians and researchers. Current foot ulcer prevention strategies are directed at the assessment and management of physical pathologies and risk factors for diabetic foot ulceration. Psychological burden and risk factors are often overlooked. This review will determine the prevalence and incidence of mental health issues among adults with diabetes mellitus who are at risk of foot ulceration. The review will focus on European Union countries. INCLUSION CRITERIA: Studies considered for inclusion will report on adults with a formal diagnosis of either type 1 or type 2 diabetes mellitus, who are at risk of foot ulceration and mental health issues. Studies will have been completed in the European Union. METHODS: A search of MEDLINE, CINAHL, AMED, Embase, Cochrane CENTRAL, and PsycINFO will be conducted for studies published in or translatable into English. Unpublished and gray literature will be searched. Studies will be selected against the review inclusion/exclusion criteria, and selected studies will be critically appraised, with data extraction and synthesis completed using the relevant JBI systematic review tools. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42021260815.

Allied health professionals' perceptions of research in the United Kingdom national health service: a survey of research capacity and culture.

BACKGROUND: With growing recognition of the importance of research in allied healthcare, the new Health Education England (HEE) research strategy articulates a need to transform Allied Health Professional (AHP) identities, culture and roles. An understanding of current AHP research capacity and culture is first required. METHODS: A cross-sectional survey targeted AHPs working in NHS health and social care settings across the United Kingdom. The validated Research Capacity and Culture tool was modified and distributed through research and professional networks. Aggregate median scores for perceived research success were categorised as adequate, more than, or less than adequate. RESULTS: Of 3344 participants, 3145 identified as HEE-defined AHPs. Individual- and organisation-level research success was perceived as adequate (median scores 4 (IQR 2 to 6); 4 (IQR 2 to 7) respectively). Team-level research success was rated less than adequate (median score 2 (IQR 1-5)). CONCLUSIONS: In the UK, AHPs working in NHS health and social care perceive individual and organisational level research skill/success to be adequate. In contrast, inadequacies in research skill/support at team level were exposed, which may hinder successful integration of allied health research into everyday health and social care practice. Recommendations are made with reference to the HEE AHP research strategy.

Footwear and insole design features for offloading the diabetic at risk foot-A systematic review and meta-analyses.

The aim of this systematic review was to identify the best footwear and insole design features for offloading the plantar surface of the foot to prevent foot ulceration in people with diabetic peripheral neuropathy. We searched multiple databases for published and unpublished studies reporting offloading footwear and insoles for people with diabetic neuropathy and nonulcerated feet. Primary outcome was foot ulcer incidence; other outcome measures considered were any standardized kinetic or kinematic measure indicating loading or offloading the plantar foot. Fifty-four studies, including randomized controlled studies, cohort studies, case-series, and a case-controlled and cross-sectional study were included. Three meta-analyses were conducted and random-effects modelling found peak plantar pressure reduction of arch profile (37 kPa (MD, -37.5; 95% CI, -72.29 to -3.61; P < .03), metatarsal addition (35.96 kPa (MD, -35.96; 95% CI, -57.33 to -14.60; P < .001) and pressure informed design 75.4 kPa (MD, -75.4 kPa; 95% CI, -127.4 to -23.44 kPa; P < .004).The remaining data were presented in a narrative form due to heterogeneity. This review highlights the difficulty in differentiating the effect of different insole and footwear features in offloading the neuropathic diabetic foot. However, arch profiles, metatarsal additions and apertures are effective in reducing plantar pressure. The use of pressure analysis to enhance the effectiveness of the design of footwear and insoles, particularly through modification, is recommended.

Behaviour change approaches for individuals with diabetes to improve foot self-management: a scoping review.

BACKGROUND: Diabetes related foot complications are increasing in complexity, frequency and cost. The application of self-management strategies can reduce the risk of individuals developing foot complications. The type, range and nature of the literature focusing on interventions that support patients with diabetic foot self-management is unknown. This scoping review aimed to i) identify self-management actions and risky behaviour avoidance strategies within interventions, ii) map the theoretical functions through which these behaviour change interventions have an effect, iii) display gaps in the research. METHODOLOGY: Arksey and Malley's (2003) 5 stage framework was followed to conduct the scoping study. This methodological framework was selected because it was developed specifically for scoping reviews and therefore offered clear methodological distinction from systematic review methodology. . Databases were searched from inception of the project until June 2020 supplemented by hand searching of reference lists. In total 988 papers were identified. These were independently screened by three reviewers, identifying 19 eligible papers. Data extraction and charting of data was independently conducted by three reviewers to identify study characteristics, self-management actions and risky behaviours. Data was charted against the COM-B (capability, opportunity, motivation, behaviour) model of behaviour to determine intervention function. RESULTS: In total 25 different foot self-management actions and risk behaviours were classified into three themes; routine self-management, trauma avoidance and warning signs and actions. Inspect feet daily received the most attention. The majority of interventions focused on knowledge and skills, but overlooked taking action and decision making. Intervention mapping identified four primary intervention functions (education, persuasion, training and enablement) used to address deficits in capability, opportunity and motivation that positively improved foot self-management behaviour. No studies targeted first ulcer prevention, and most either did not measure or improve foot health outcomes. CONCLUSION: This review charted the evidence for interventions promoting diabetic foot self-management through a theoretical behaviour change perspective. A core set of behaviour change activities and intervention functions associated with positive changes in behaviour were identified. This information will provide researchers with a useful basis for developing self-management interventions.

INSoles To Ease Pressure (INSTEP) Study: a multicentre, randomised controlled feasibility study to compare the effectiveness of a novel instant optimised insole with a standard insole for people with diabetic neuropathy: a study protocol.

INTRODUCTION: Foot ulceration is a multifactorial complication of diabetes. Therapeutic insoles and footwear are frequently used to reduce elevated tissue pressures associated with risk of foot ulceration. A novel protocol using in-shoe pressure measurement technology to provide an instant optimised insole and house shoe solution has been developed, with the aim of reducing foot ulceration. AIM: This study aims to assess the feasibility of conducting a multicentre randomised controlled trial to compare the effectiveness of a novel instant optimised insole with a standard insole for people with diabetic neuropathy. METHODS AND ANALYSIS: This study is a participant and assessor blinded, randomised, multicentre parallel group feasibility trial with embedded qualitative study. Seventy-six participants will be recruited from three podiatry clinics and randomised to an optimised insole plus usual care (intervention group) or standard insole plus usual care (control group) using a minimisation by randomisation procedure by study centre and previous ulcer status. Assessment visits and data collection will be at baseline, 3 months, 6 months and 12 months. Feasibility and acceptability of the trial procedures will be determined in terms of recruitment and retention rates, data completion rates, intervention adherence and effectiveness of the blinding.Assessment of the appropriateness and performance of outcome measures will inform selection of the primary and secondary outcomes and sample size estimate for the anticipated definitive randomised controlled trial. Clinical outcomes include incidence of plantar foot ulceration and change in peak plantar pressure. Twelve participants (four from each centre) and three treating podiatrists (one from each centre) will be interviewed to explore their experiences of receiving and delivering the intervention. ETHICS AND DISSEMINATION: The study was approved by the South-West Exeter Research Ethics Committee. Findings will be disseminated through conference presentations, public platforms and academic publications. TRIALS REGISTRATION NUMBER: ISRCTN16011830; Pre-results.

Footwear and insole design features to prevent foot ulceration in people with diabetes: a systematic review protocol.

REVIEW QUESTION/OBJECTIVE: The aim of this systematic review is to identify the key design features of footwear and insoles that are used to offload the plantar surface of the foot to prevent foot ulceration in adults with diabetes.More specifically, the objectives are to identify the key design features of footwear and insoles to offload the plantar surface of the foot with regard to.

Getting the right balance: insole design alters the static balance of people with diabetes and neuropathy.

BACKGROUND: Over 1 in 3 older people with diabetes sustain a fall each year. Postural instability has been identified as independent risk factor for falls within people with Diabetic Peripheral Neuropathy (DPN). People with DPN, at increased risk of falls, are routinely required to wear offloading insoles, yet the impact of these insoles on postural stability and postural control is unknown. The aim of this study was to evaluate the effect of a standard offloading insole and its constituent parts on the balance in people with DPN. METHODS: A random sample of 50 patients with DPN were observed standing for 3 × 30 s, and stepping in response to a light, under five conditions presented in a random order; as defined by a computer program; 1) no insole, 2) standard diabetic: a standard offloading insole made from EVA/poron®, and three other insoles with one design component systematically altered 3) flat: diabetic offloading insole with arch fill removed, 4) low resilient memory: diabetic offloading insole with the cover substituted with low resilience memory V9, 5) textured: diabetic offloading insole with a textured PVC surface added (Algeos Ltd). After each condition participants self-rated perceived steadiness. RESULTS: Insole design effected static balance and balance perception, but not stepping reaction time in people with DPN. The diabetic and memory shaped insoles (with arch fill) significantly increased centre of pressure velocity (14 %, P = 0.006), (13 %, P = 0.001), and path length (14 %, P = 0.006), (13 %, P = 001), when compared to the no insole condition. The textured shaped and flat soft insole had no effect on static balance when compared to the no insole condition (P > 0.05). CONCLUSION: Insoles have an effect on static balance but not stepping reaction time. This effect is independent of neuropathy severity. The addition of a textured cover seems to counter the negative effect of an arch fill, even in participants with severe sensation loss. Static balance is unaffected by material softness or resilience. Current best practice of providing offloading insoles, with arch fill, to increase contact area and reduce peak pressure could be making people more unstable. Whilst flat, soft insoles maybe the preferable design option for those with poor balance. There is a need to develop an offloading insole that can reduce diabetic foot ulcer risk, without compromising balance.