Study to Assess Remote Imaging System to Monitor Diabetic Foot Ulcers

The goal of this observational pilot study is to evaluate whether a new remote monitoring platform (TASHA) can support accurate and reliable assessment of diabetic foot ulcers in adult patients receiving care in a UK NHS clinic. The main questions it aims to answer are: Can the TASHA platform provide ulcer assessment data (e.g., size, depth, visible infection) that aligns with in-clinic evaluations by healthcare professionals? Can patients accurately perform self-scanning of their ulcers using the platform under clinical supervision? What is the variation (inc. root mean square error) between clinician-led and patient-led scans? Participants will: * Attend a standard in-clinic ulcer assessment as part of their usual care Undergo an additional 3D foot scan using the TASHA platform during their clinic visit. * Be guided to perform a self-scan using the same platform, with clinical staff present. * Have their scan data reviewed remotely by a clinician to compare with in-clinic assessments. * This feasibility study will inform the design of future larger-scale trials and contribute to regulatory development of the TASHA platform as a digital medical device.

NCT Number	NCT07013448
Lead Sponsor	Medical Intelligence Group Collaborators: Tameside Hospital NHS Foundation Trust
Conditions	Diabetic Foot Ulcer, Diabetic Foot Ulcer (DFU)
Enrollment	40 participants
Start Date	2025-09
Primary Completion	2026-04 (estimated)
Study Completion	2026-06 (estimated)
Updated on ClinicalTrials.gov	2025-06-10