FeetSee Thermal Images Collection Protocol in Diabetes Patients

Summary

Diabetic foot ulcers (DFUs) are a major cause of morbidity, lower-extremity amputation and healthcare costs in people with diabetes. DFUs often develop without pain or warning symptoms because of diabetic peripheral neuropathy, so patients may not recognise early signs of tissue damage. Monitoring plantar foot skin temperature is a promising strategy to detect early "hot-spots" of inflammation that precede ulceration and could trigger timely preventive action.

This prospective, single-group study will enrol adults with type 1 or type 2 diabetes, a history of plantar DFU that has been healed for at least 6 weeks, and evidence of diabetic peripheral neuropathy. Participants will be recruited from hospital clinics in the United Kingdom and Lithuania. After a baseline assessment (including medical history and neuropathy testing), each participant will receive the FeetSee system, consisting of a thermal camera attached to their own smartphone or tablet, a stand, and the FeetSee mobile application.

Participants will be instructed to acquire thermal and optical images of both feet at home at least once per day for 6-9 months, or until a new DFU develops. Images will be uploaded securely to cloud storage, where the FeetSee algorithm will analyse temperature patterns, comparing mirrored regions of both feet to identify potential inflammatory "hot-spots" associated with DFU risk. Participants will continue to receive standard clinical care throughout the study.

The primary objective is to generate a longitudinal foot temperature dataset in this high-risk population and use it to retrospectively test and refine the FeetSee algorithm for predicting DFU occurrence. The primary outcome is the incidence of new DFUs during follow-up. Secondary objectives are to assess the feasibility and acceptability of daily device use (recruitment, retention, adherence, user and healthcare-provider questionnaires) and to document any device-related or system-related safety issues.

Conditions

• Diabetic Foot Ulcer

Interventions

DEVICE

FeetSee thermal camera

The FeetSee Device consists of: (1) a smartphone/tablet-connected thermal imaging camera, (2) a mobile application installed on the participant's own mobile device, and (3) a stand to hold the device in a fixed position for imaging. Participants are instructed to take at least one bilateral plantar thermal and optical image of their feet per day at home over 6-9 months. Images are securely uploaded to cloud storage. The device is used for thermal image collection and is not a replacement for standard diabetic foot self-examination and routine clinical foot care; no treatment decisions are mandated by the study protocol.

Sponsors & Collaborators

• Horizon 2020 - European Commission

  collaborator OTHER

• Manchester University NHS Foundation Trust

  collaborator OTHER_GOV

• Lancashire Teaching Hospitals NHS Foundation Trust

  collaborator OTHER

• Vilnius University Hospital Santaros Klinikos

  collaborator OTHER

• Diabetis JSC

  lead INDUSTRY

Principal Investigators

• Neil Reeves, Prof, Phd · Manchester University NHS Foundation Trust (MFT)

• Loretta Vileikyte, Prof, MD · Lancashire Teaching Hospitals NHS Foundation Trust

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-10

Primary Completion

2027-05-30

Completion

2027-05-30

FDA Device

Yes

Countries

• Lithuania
• United Kingdom

Study Locations