Study to Assess Remote Imaging System to Monitor Diabetic Foot Ulcers

Sponsor
Medical Intelligence Group
Study ID
NCT07013448
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Foot scan — OTHER
    This does not constitute a intervention but all participants will undergo image scans of their ulcer

Study Details

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.

Key Dates

First listed
Jun 10, 2025
Start date
Sep 30, 2025
Status verified
Jun 2025
Primary completion
Apr 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: Patients with DFU
    Only one group used as all participants will receive the standard care as well as have a foot scan take with a non-invasive and non-ionising scanner

Primary Outcome Measure

Agreement in Ulcer Stage Classification Between Remote and In-Clinic Assessments [ Time Frame: Each clinical visit per patient unto 24 weeks ]

Central Contacts

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