About this trial
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.
Eligibility criteria
Qualifiers
Adults aged 18 years or older
Diagnosed with a diabetic foot ulcer at the time of recruitment
Receiving routine care at the participating NHS clinic
Able to provide informed consent
Disqualifiers
Presence of non-diabetic foot ulcers
Severe cognitive or physical impairments that prevent scanning or understanding instructions
Active infection or medical instability requiring urgent intervention
Participation in another interventional study that may interfere with this assessment
Trial design
Treatments tested in this trial
- Foot scan
Treatment groups
Sponsors and collaborators
Medical Intelligence Group
Lead sponsor
Tameside Hospital NHS Foundation Trust
Collaborator