EU Feetsee
Research type
Research Study
Full title
Foot temperature and diabetic foot ulcer risk: Using the FeetSee device to generate a unique foot temperature dataset.
IRAS ID
345382
Contact name
Loretta Vileikyte
Contact email
Sponsor organisation
Diabetis JSC
Duration of Study in the UK
1 years, 6 months, 31 days
Research summary
Diabetic foot ulcers are a major health and economic challenge to health services around the world. Before the skin breaks down to form a foot ulcer, it typically heats up. Using these ‘hot spots’ to try and prevent foot ulcers could be a possibility if we can generate appropriate algorithms to make accurate predictions on when and where foot ulcers will occur. This study primarily aims to generate prospective foot temperature data collected from people with diabetes to test the current FeetSee system algorithm and inform development of future algorithm refinements aimed at supporting diabetic foot ulcer prevention through identification of ‘hot-spots’ on the foot. These data and the algorithm generated will inform the scientific underpinning for the development of the FeetSee health technology. Secondary objectives are to understand feasibility of device use, examine the determinants of FeetSee device acceptance and document any device/system safety issues.
Participants with diabetes at risk of foot ulceration will be recruited. Participants will have type I or II diabetes, a history of previous plantar foot ulcers but be ulcer free at time of recruitment and at least one palpable foot pulse. Participants will be excluded if they have active Charcot neuro-osteoarthropathy, severe vascular disease, lower limb/foot amputation greater than two lesser toes or a physical/mental condition that limits their ability to participate. Participants will be recruited from hospital sites in both the UK and Lithuania.
The FeeSsee system for use in this study will comprise an iPad with app installed, thermal camera and stand. Participants will be asked to take photographs of both feet individually with the FeetSee system at least once per day and ideally at the same time of day. Participants will be asked to remove shoes and socks and wait ~10 minutes before taking a photograph to allow time for their foot temperature to ‘normalise’. Participants will be asked to do this for a minimum of 6 months and maximum of 9 months (this will depend upon the date they were recruited into the study, with participants recruited earlier being followed up for 9 months). Technical assistance and any troubleshooting will be provided by the study researchers. User acceptance of the FeetSee device will be assessed with the Unified Theory of Acceptance and Use of Technology (UTAUT) questionnaire. This questionnaire examines the way in which key psychosocial domains interact to influence behavioural intention to adopt a technology in a healthcare context for both patients and health professionals. Additionally, the number of technical/trouble shooting interactions will be documented. Participants will be sent a reminder message if they fail to take foot photographs for 5 consecutive days and they will be considered lost to follow-up after 21 days of not taking a photograph. Participants and researchers will be encouraged to report any device safety issues and these will be recorded.
Demographic and relevant medical background information will be collected from study participants. Participants’ feet will be examined and assessed for sensation to test the level of peripheral neuropathy. These measures will be taken at baseline only. The UTAUT questionnaire will be administered at baseline and after 3, 6 and 9 months of follow up.
Following the completion of study data collection, thermal image data gathered during the study will be analysed to retrospectively test and refine the FeetSee algorithm (primary study outcome) aimed at supporting foot ulcer prevention through identification of ‘hot-spots’ on the foot. The study secondary outcome measures of feasibility (recruitment, retention and adherence), patient and healthcare provider acceptability (acceptance and use of technology questionnaire) and device safety (participant and research reports of any issues) will be investigated from the measures described above.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
25/YH/0101
Date of REC Opinion
13 Jun 2025
REC opinion
Favourable Opinion