Study to Assess Remote Imaging System to Monitor Diabetic Foot Ulcers

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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.

Eligibility

Primary outcome measure(s)

• Agreement in Ulcer Stage Classification Between Remote and In-Clinic Assessments — Each clinical visit per patient unto 24 weeks
  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
• Agreement in Ulcer Surface Area Measurement Between Remote and In-Clinic Assessments — At each clinical visit per participant, up to 24 weeks
  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)
• Agreement in Ulcer Depth Measurement Between Remote and In-Clinic Assessments — At each clinical visit per participant, up to 24 weeks
  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)
• Agreement in Detection of Visible Signs of Infection Between Remote and In-Clinic Assessments — At each clinical visit per participant, up to 24 weeks
  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

Trial sites (1)

Other trials for the same condition