Study to Assess Remote Imaging System to Monitor Diabetic Foot Ulcers

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedical Intelligence Group

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

40 Participants
are divided into 1 treatment group

Sponsors and collaborators

Medical Intelligence Group

Lead sponsor

Tameside Hospital NHS Foundation Trust

Collaborator