Study to Assess Remote Imaging System to Monitor Diabetic Foot Ulcers

NCT07013448 | Not Yet Recruiting

• 1 other identifier: 344307
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

DFU; Monitoring

Outcome Measures

Primary Outcomes (4)

• Agreement in Ulcer Stage Classification Between Remote and In-Clinic Assessments

  Assessment of agreement in diabetic foot ulcer (DFU) stage classification between in-clinic assessments by healthcare professionals and remote assessments based on TASHA platform scan data. Classification will use a standard ulcer staging system (e.g., Wagner or SINBAD). Agreement will be measured using Cohen's Kappa coefficient to evaluate inter-rater reliability for categorical data. This will determine the platform's ability to support accurate remote clinical interpretation. Unit of Measure: Cohen's Kappa coefficient

  Each clinical visit per patient unto 24 weeks

• Agreement in Ulcer Surface Area Measurement Between Remote and In-Clinic Assessments

  Comparison of ulcer surface area (cm²) between in-clinic manual measurement and remote assessments using TASHA platform 3D scans. Agreement will be evaluated using Intraclass Correlation Coefficient (ICC) and Bland-Altman analysis to determine alignment between manual and digital assessments. This will help establish whether remote scanning can reliably replicate clinical measurements of DFU size. Unit of measure - Ulcer surface area (cm²)

  At each clinical visit per participant, up to 24 weeks

• Agreement in Ulcer Depth Measurement Between Remote and In-Clinic Assessments

  Comparison of ulcer depth (mm) assessed in person by clinicians versus measurements obtained from TASHA platform-generated 3D scans. Statistical agreement will be analysed using Intraclass Correlation Coefficient (ICC) and root mean square error (RMSE). The goal is to determine the level of accuracy and consistency between traditional manual depth estimates and platform-generated data. Unit of measurement - Ulcer depth (mm)

  At each clinical visit per participant, up to 24 weeks

• Agreement in Detection of Visible Signs of Infection Between Remote and In-Clinic Assessments

  Comparison of in-clinic and remote assessments in identifying visible infection indicators such as erythema, exudate, and swelling using TASHA platform images. Agreement will be measured using percentage agreement and Cohen's Kappa for categorical variables. This will inform whether remote imaging data supports consistent clinical detection of surface-level infection features. Measured in Percentage agreement / Cohen's Kappa coefficient

  At each clinical visit per participant, up to 24 weeks

Secondary Outcomes (1)

• Root Mean Square Error Between Clinician and Patient Self-Scans of Ulcer Surface Area

  At each clinical visit per participant, up to 24 weeks

Study Arms (1)

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

Other: Foot scan

Interventions

Foot scan OTHER

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

Patients with DFU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adult patients (aged 18 and over) with a clinically diagnosed diabetic foot ulcer, who are receiving routine care at an NHS diabetic foot clinic in the UK. Participants will be recruited during scheduled clinical visits and must be able to provide informed consent and physically engage with the TASHA scanning platform. The study aims to include a representative sample of DFU patients, covering a range of ulcer sizes, locations, and stages, to assess the platform's performance in real-world clinical conditions.

You may qualify if:

• 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
• Able to sit and engage with the TASHA scanning device
• Willing to attempt a supervised self-scan of the affected foot

You may not qualify if:

• 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
• Inability to communicate in English (unless appropriate translation or support is available)

Sponsors & Collaborators

• Medical Intelligence Group: lead
• Tameside Hospital NHS Foundation Trust: collaborator

Study Sites (1)

Tameside General Hospital

Ashton-under-Lyne, UK, OL6 9RW, United Kingdom

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Central Study Contacts

Sagar Jadeja, BDS, PhD, MFDS, AKC

CONTACT

+447923387582; sagar@mig-health.com

Divia Bhatnagar, BSc, MEng

CONTACT

+44 7725 91685; divia@mig-health.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: June 10, 2025
• Study Start: September 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 10, 2025

Record last verified: 2025-06

Locations

GB (1)