ClinicaliQ Trial Snapshot
- FeetSee Thermal Images Collection Protocol in Diabetes Patients — Recruiting • Cardiology / Cardiovascular • NCT07300163.
- What is being tested: FeetSee thermal imaging technology is being evaluated as a potential early detection tool for diabetic foot ulcers by collecting thermal images to identify temperature changes that may indicate developing foot complications before visible ulcers appear.
- Patient eligibility overview: The trial includes adults with diabetes mellitus who have or are at risk of developing diabetic peripheral neuropathy and foot ulcers, enabling assessment of the imaging tool across the spectrum of diabetic foot disease.
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What This Trial Is Studying
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…
Eligibility Snapshot
- : * 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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.