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
This trial does not accept healthy volunteersQualifiers
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 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Foot scan
Other interventionThis does not constitute a intervention but all participants will undergo image scans of their ulcer
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Patients with DFU1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Each clinical visit per patient unto 24 weeks2
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)
Time frame
At each clinical visit per participant, up to 24 weeks3
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)
Time frame
At each clinical visit per participant, up to 24 weeks4
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
Time frame
At each clinical visit per participant, up to 24 weeksSecondary outcomes
1
Root Mean Square Error Between Clinician and Patient Self-Scans of Ulcer Surface Area
To evaluate the difference in ulcer surface area measurements (cm²) between clinician-performed and patient-performed TASHA scans. RMSE will be used to quantify error and variability between the two scan types. This will help assess the accuracy and feasibility of supervised self-scanning in a clinical setting and inform future deployment of remote self-monitoring workflows. Unit of measure - RMSE (cm²)
Time frame
At each clinical visit per participant, up to 24 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical Intelligence Group
Lead sponsor
Tameside Hospital NHS Foundation Trust
Collaborator
Source ClinicalTrials.gov
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