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โ† Trials
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FeetSee Thermal Images Collection Protocol in Diabetes Patients

Recruitingn/aAges 18 Years - anyAllDiabetis JSC
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • FeetSee thermal camera
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Where

4 sites
Vilnius University Hospital Santaros Klinikos
Vilnius, Lithuania
Blackpool Teaching Hospitals NHS Trust
Blackpool, United Kingdom
Lancashire Teaching Hospitals NHS Foundation Trust
Lancaster, United Kingdom
Manchester University NHS Foundation Trust (MFT)
Manchester, United Kingdom
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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