Happier Feet- A Smart Insole for Diabetic Foot Ulceration Prevention
Research type
Research Study
Full title
Happier Feet- Disrupting the vicious cycle of healthcare decline in Diabetic Foot Ulceration through active prevention: The Future of self-managed care
IRAS ID
307041
Contact name
Helen Dawes
Contact email
Sponsor organisation
University of Exeter
Duration of Study in the UK
0 years, 8 months, 1 days
Research summary
Diabetic Foot Ulceration (DFU) is an important national challenge, with 25% of people with diabetes developing an ulcer in their lifetime leading to more than 7000 amputations per year. There is a burden on the NHS estimated to be >£1Billion annually.
We aim to develop a smart sensing insole that has the potential to predict where DFUs could occur on the foot using a combination of sensors to measure temperature, pressure and gait.
The study has two phases. The first phase (Phase 1) will focus on the design and development of the smart sensing insole in which we will use a user-centered approach of design for the insole, engaging diabetics at risk of a DFU formation and NHS health professionals through focus groups. This phase is held at the University of Manchester.
Phase 1 will take approximately 6 months, where participants will participate in 5 one-hour focus groups, held no longer than two months apart. Online questionnaire versions of the focus group questions will also be distributed to reach more participants.
The second phase (Phase 2) will involve provisionally testing the smart insole's ability to collect valid and reliable data from all sensors in a safe, controlled lab setting. We aim to recruit diabetics with risk of DFUs as well as healthy controls for this validation study at the medical laboratory of the University of Exeter.
Phase 2 will take approximately 3 months, where participants will attend three sessions on three non-consecutive days. The sessions include a baseline visit to confirm eligibility, fitness and some preliminary data collection; followed by two sessions of testing the smart insole with light walking activities. Each session will take no longer than 1 hour 35 minutes.
Participants will be recruited separately for each phase of the study.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
22/NW/0216
Date of REC Opinion
25 Jul 2022
REC opinion
Favourable Opinion