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.

Eligibility

Inclusion Criteria:

* 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.
* Presence of diabetic peripheral neuropathy defined by either of the following:

  * Inability to detect the monofilament (10g) applied at two foot sites, including the apex of the Hallux (ADA guidelines 2008 Diabetes Care 31(1)).
  * A Vibration Perception Threshold (VPT) \>20V, and/or by inability to detect application of the monofilament at the apex of the Hallux.
* Presence of at least one palpable foot pulse.

Exclusion Criteria:

* Active foot ulceration.
* Active Charcot neuro-osteoarthropathy.
* Severe vascular disease (complete absence of any foot pulses).
* Lower limb/foot amputation greater than metatarsophalangeal disarticulation.
* Active malignancy, immunosuppressive disease.
* Physical or mental condition(s) that limit the ability to follow instructions for the study, based on clinical judgment by the physician, such as inability to use the device without assistance.
* Current participation in another clinical investigation of a medical device that is contraindicated for either study procedure/outcome.

Conditions2

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