Insole Optimisation for Ulcer Prevention: a Feasibility Trial

Diabetic Clinical Trial

Official title: Prevention of Foot Ulcer Recurrence in People With Diabetes Using an In-shoe Pressure Measurement Technology: A Randomised Control Trial Feasibility Study

Status Not yet recruiting

Clinical Trial Summary

Insoles are designed to reduce increased loads and re-ulceration risk in patients with diabetes. The investigators previous research findings suggest that an instant insole solution may benefit some, but effectiveness is difficult to predict. The investigators propose a feasibility study using in-shoe pressure analysis to optimise the protective effect of insoles and footwear with the aim of reducing re-ulceration rates.

Early indications from exploratory case studies within the real world clinical setting suggest that by implementing the investigators previous published research findings the investigators can optimise effectiveness and reduce outcome variability of protective footwear and insoles provided to patients at risk of re-ulceration.

However a further randomised control trial is necessary to evaluate the effectiveness of in-shoe pressure analysis in reducing re-ulceration rates within the NHS setting. The proposed feasibility study will recruit 20 participants from the multidisaplinary diabetic foot clinic Derriford Hospital and allocate them to either 1) Routine insoles and footwear provision or 2) Routine insole and footwear provision, and temporary insole provision with optimisation. The findings from the feasibility study will inform protocol development for a larger clinical trial. The results of the feasibility study will be used to strengthen a protocol for a grant application to conduct the main RCT. A secondary output from the pilot study will be the dissemination of findings in a peer reviewed journal and at conference.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetic
• Neuropathic
• Past Ulceration

• NCT number: NCT01948479
• Study type: Interventional
• Source: University of Plymouth
• Contact: Joanne Paton, PhD
• Phone: 01752 588845
• Email: joanne.paton@plymouth.ac.uk
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2014
• Completion date: January 2015