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

Abstract

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 optimizing plantar foot pressure reduction in people with diabetes has been developed. Aim: To explore the feasibility and acceptability of testing an optimized insole compared with an active control insole to reduce plantar pressures for people with diabetic peripheral neuropathy.Methods: A double-blinded multicentre feasibility RCT with an embedded qualitative study. In addition to usual care, participants were randomized to either an optimized insole group (Intervention) or a standard cushioned insole group (Active control). Participants were assessed at baseline, 3, 6 and 12 months with clinical outcome of 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 analyzed using descriptive statistics (quantitative data) and thematic analysis (qualitative data).Results: Screened were142 patients from which 61 were recruited; 30 participants were randomized 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. Mean difference in MPPP between the Intervention and Active control groups for all regions-of-interest combined favoured the Intervention, with increases from 87kPa at post-randomization to 255kPa at 12-months. 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 optimized 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 Randomized Controlled Trial Number: ISRCTN16011830. Registered 9th October 2017, https://www.isrctn.com/ISRCTN16011830