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Study to Assess Remote Imaging System to Monitor Diabetic Foot Ulcers

NCT07013448 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2025-06-10

No results posted yet for this study

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.

Conditions

  • Diabetic Foot Ulcer
  • Diabetic Foot Ulcer (DFU)

Interventions

OTHER

Foot scan

This does not constitute a intervention but all participants will undergo image scans of their ulcer

Sponsors & Collaborators

  • Tameside Hospital NHS Foundation Trust

    collaborator OTHER

  • Medical Intelligence Group

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2026-04-30
Completion
2026-06-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07013448 on ClinicalTrials.gov