FeetSee Thermal Images Collection Protocol in Diabetes Patients
ConditionDiabetic Foot Ulcer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDiabetis JSC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males/females aged over 18 years.
Type 1 or type 2 diabetes.
History of plantar diabetic foot ulcer(s).
Foot ulcer healed for at least 6 weeks before entry into study, as determined by a specialist healthcare provider.
Disqualifiers
Active foot ulceration.
Active Charcot neuro-osteoarthropathy.
Severe vascular disease (complete absence of any foot pulses).
Lower limb/foot amputation greater than metatarsophalangeal disarticulation.
Trial population
Adults (≥18 years) with type 1 or type 2 diabetes, a history of plantar diabetic foot ulcer(s) that have been fully healed for at least 6 weeks, clinical evidence of diabetic peripheral neuropathy, and at least one palpable foot pulse. This is a high-risk population for recurrent plantar diabetic foot ulceration, without active ulceration, active Charcot neuro-osteoarthropathy, severe peripheral arterial disease, or major lower-limb amputation (above metatarsophalangeal disarticulation).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
FeetSee thermal camera
DeviceThe 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: FeetSee Foot Monitoring Cohort1 intervention
Trial outcomes
Primary outcomes
1
DFU occurrence over the six to nine-month follow-up period.
Proportion of enrolled participants who develop at least one new plantar diabetic foot ulcer (DFU) during the study follow-up.
Time frame
From baseline (enrolment) until study completion or development of a new DFU, up to 9 months per participant.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Diabetis JSC
Lead sponsor
Horizon 2020 - European Commission
Collaborator
Manchester University NHS Foundation Trust
Collaborator
Lancashire Teaching Hospitals NHS Foundation Trust
Collaborator
Vilnius University Hospital Santaros Klinikos
Collaborator
Source ClinicalTrials.gov