Clinical Research Directory

Study to Assess Remote Imaging System to Monitor Diabetic Foot Ulcers

Sponsor: Medical Intelligence Group

Summary

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.

Official title: Pilot Study of a Novel Non-invasive Multimodal Imaging System in the Monitoring of Diabetic Foot Ulcer Progression

Key Details

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Interventions

Locations (1)