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