Happier Feet- A Smart Insole for Diabetic Foot Ulceration Prevention

This study aims to design, develop, and evaluate a smart insole to predict the formation of diabetic foot ulcers (DFUs) in diabetic participants at risk of developing them. The study will be conducted in two phases, using mixed-method research and engaging both diabetic participants and NHS clinicians. In Phase 1, the user-centred design of the smart insole will be developed through focus groups and online questionnaires, and a preliminary safety evaluation of the insole will be conducted with healthy team members. In Phase 2, the insole will be tested, validated, and data will be collected through baseline visits, lab studies, and insole data collection with shape-changed (pressure off-loading) insoles. The study will be conducted by researchers from the University of Manchester and the University of Exeter. It will include 10 people with diabetes and 10 healthy controls in Phase 2.