Diabetic Foot UlcerNCT07013448
Study to Assess Remote Imaging System to Monitor Diabetic Foot Ulcers
An observational study of Diabetic Foot Ulcer and Diabetic Foot Ulcer (DFU), run by Medical Intelligence Group at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Diabetic Foot Ulcer (DFU)
- What is being tested?
- Foot scan
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2025to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Tameside General Hospital
Ashton-under-Lyne, UK, OL6 9RW
Margaret Cooper, +440161 922 4011, Margaret.Cooper@tgh.nhs.uk
Rebecca Roberts, Rebecca.Roberts@tgh.nhs.uk
About this study
Official title: Pilot Study of a Novel Non-invasive Multimodal Imaging System in the Monitoring of Diabetic Foot Ulcer Progression
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?
Read more
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.
Read the detailed description
This is a prospective, single-site, single-arm pilot study designed to evaluate the feasibility, usability, and technical performance of the Tissue Analytics System for Health Assessments (TASHA) platform, a novel investigational medical device developed by Medical Intelligence Group Ltd. The platform integrates a non-invasive, high-resolution 3D scanning module with a secure data interface to generate a digital twin of diabetic foot ulcers (DFUs), allowing clinicians to assess wound status remotely and, in future iterations, support patient-led ulcer self-monitoring.
Study Rationale Diabetic foot ulcers are among the most debilitating and costly complications of diabetes, associated with high risks of infection, hospitalisation, and lower-limb amputation. Early and continuous monitoring of DFUs is critical to guide treatment, detect deterioration, and evaluate healing progression. However, current models of care rely predominantly on in-clinic assessments that are often infrequent due to healthcare capacity limitations, geographic access barriers, or logistical constraints.
Remote monitoring has the potential to increase continuity of care, improve early detection of wound deterioration, and reduce the clinical burden on specialist foot care services. The TASHA platform aims to address these needs by enabling structured, repeatable capture of wound images and clinical metadata for remote review and longitudinal tracking.
Study Design
This is a non-randomised, observational, exploratory pilot study involving up to 30 adult participants with active diabetic foot ulcers, conducted at a single National Health Service (NHS) clinic in the United Kingdom. The study is not powered to demonstrate clinical efficacy but is instead focused on evaluating:
Technical performance and image quality Accuracy and consistency of ulcer assessments using TASHA data Feasibility of supervised patient self-scanning Inter-rater reliability between in-clinic and remote clinical reviewers Study Procedures
Following informed consent, eligible participants will attend a routine diabetic foot clinic appointment, during which the following study-related activities will occur:
Standard Clinical Assessment: Performed by an NHS-employed healthcare professional. Ulcer stage, size, depth, presence of infection, and wound condition will be assessed and recorded according to standard local practice.
Clinician-led TASHA Scan: The healthcare professional will perform a 3D scan of the ulcer using the TASHA device. The system uses structured light and depth-sensing to construct a digital model of the ulcer and surrounding tissue, with accompanying photographic documentation.
Patient Self-Scan: Participants will then be guided to perform a self-scan of their ulcer using the same TASHA platform, under clinical supervision. This is designed to evaluate usability, scan quality, and the potential for future unsupervised home-based scanning.
Remote Clinical Review: TASHA scan data will be de-identified and reviewed by a remote clinician who is blinded to the in-clinic findings. They will assess wound characteristics using a structured form equivalent to the in-person evaluation.
Optional Feedback Collection: Participants may optionally provide structured feedback regarding the ease of use, instructions clarity, and perceived difficulty of the scanning task.
Device Description
TASHA consists of:
A 3D scanning unit utilising structured light or depth-sensing technology A software platform for scan acquisition, data encryption, and transfer A secure clinician portal for visualising digital twins and conducting remote assessments The device is currently unmarked (not yet UK Conformity Assessed [UKCA] or Conformité Européenne [CE] certified) and is being evaluated solely under ethics-approved investigational use conditions.
Data Management and Analysis All identifiable data will be securely stored on encrypted NHS infrastructure and will not be accessed by the device developer. Anonymised data (including wound scans and structured assessment metadata) will be securely transferred to Medical Intelligence Group Ltd for performance evaluation and iterative development of the TASHA platform.
Data Handling:
Role-based access control and encryption will be implemented across all data storage systems Anonymisation will include removal of all identifiers prior to data export Data will not be shared, sold, or commercialised beyond internal research and regulatory preparation Primary data outputs will include ulcer size, surface area, depth estimation, infection markers (as visible), and scan metadata.
Planned Statistical Analysis Concordance analysis: Agreement between in-clinic and remote assessments will be assessed using Cohen's Kappa for categorical variables (e.g. ulcer stage) and Intraclass Correlation Coefficients (ICC) or Bland-Altman plots for continuous measures (e.g. ulcer size, depth).
Root Mean Square Error (RMSE): RMSE will be used to quantify measurement error between clinician and patient-generated scans, particularly for spatial metrics like ulcer area and volume.
Sensitivity and Specificity: The platform's ability to detect changes in ulcer condition (improvement, worsening, stability) will be calculated against in-clinic assessments as the reference standard.
Inter-rater Reliability: Multiple clinician reviewers (in-person and remote) will be compared to assess consistency in interpretation of TASHA scan data.
Descriptive Statistics: Demographics, ulcer characteristics, scan duration, and usability metrics (e.g. assistance required) will be summarised using basic descriptive statistics.
This analysis will inform future statistical powering and endpoint selection for a definitive trial.
Ethical and Regulatory Compliance This study has received ethics approval from a UK NHS Research Ethics Committee via the Integrated Research Application System (IRAS). It will be conducted in compliance with the UK Policy Framework for Health and Social Care Research, the Declaration of Helsinki, and Good Clinical Practice (GCP) guidelines.
Risk management and insurance:
NHS indemnity applies to any clinical care-related activity carried out by NHS-employed staff Medical Intelligence Group Ltd has secured commercial liability insurance for all device-related research risks and data processing activity No adverse events are anticipated, as the TASHA system is non-invasive and used solely to supplement standard care assessments.
Future Applications
Insights from this pilot study will be used to:
Validate the clinical utility of the TASHA platform Optimise usability features for patient-led scanning Support UKCA/CE marking and regulatory submissions Design a statistically powered, multi-site clinical investigation Enable remote wound monitoring capabilities within community and home settings
- Conditions
- Diabetic Foot Ulcer, Diabetic Foot Ulcer (DFU)
- Being tested
- Foot scan
- Keywords
- DFU, Monitoring
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot scanOther
This does not constitute a intervention but all participants will undergo image scans of their ulcer
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Foot scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
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)
Measured: At each clinical visit per participant, up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study startSep 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Intelligence Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tameside Hospital NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013448
- Sponsor's protocol ID
- 344307
- Status last verified
- Jun 2025
- First submitted
- 12 May 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The type of data may be proprietary and may be linked to future studies
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Novel Non-invasive Multimodal Imaging System in the Monitoring of Diabetic Foot Ulcer Progression
- ClinicalTrials.gov ID
- NCT07013448
- Acronym / sponsor ID
- 344307
- Conditions
- Diabetic Foot Ulcer, Diabetic Foot Ulcer (DFU)
- Keywords
- DFU, Monitoring
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical Intelligence GroupIndustry (pharma, biotech, devices)
- Collaborators
- Tameside Hospital NHS Foundation Trust
- Study start
- Sep 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, single-site, single-arm pilot study designed to evaluate the feasibility, usability, and technical performance of the Tissue Analytics System for Health Assessments (TASHA) platform, a novel investigational medical device developed by Medical Intelligence Group Ltd. The platform integrates a non-invasive, high-resolution 3D scanning module with a secure data interface to generate a digital twin of diabetic foot ulcers (DFUs), allowing clinicians to assess wound status remotely and, in future iterations, support patient-led ulcer self-monitoring.
Study Rationale Diabetic foot ulcers are among the most debilitating and costly complications of diabetes, associated with high risks of infection, hospitalisation, and lower-limb amputation. Early and continuous monitoring of DFUs is critical to guide treatment, detect deterioration, and evaluate healing progression. However, current models of care rely predominantly on in-clinic assessments that are often infrequent due to healthcare capacity limitations, geographic access barriers, or logistical constraints.
Remote monitoring has the potential to increase continuity of care, improve early detection of wound deterioration, and reduce the clinical burden on specialist foot care services. The TASHA platform aims to address these needs by enabling structured, repeatable capture of wound images and clinical metadata for remote review and longitudinal tracking.
Study Design
This is a non-randomised, observational, exploratory pilot study involving up to 30 adult participants with active diabetic foot ulcers, conducted at a single National Health Service (NHS) clinic in the United Kingdom. The study is not powered to demonstrate clinical efficacy but is instead focused on evaluating:
Technical performance and image quality Accuracy and consistency of ulcer assessments using TASHA data Feasibility of supervised patient self-scanning Inter-rater reliability between in-clinic and remote clinical reviewers Study Procedures
Following informed consent, eligible participants will attend a routine diabetic foot clinic appointment, during which the following study-related activities will occur:
Standard Clinical Assessment: Performed by an NHS-employed healthcare professional. Ulcer stage, size, depth, presence of infection, and wound condition will be assessed and recorded according to standard local practice.
Clinician-led TASHA Scan: The healthcare professional will perform a 3D scan of the ulcer using the TASHA device. The system uses structured light and depth-sensing to construct a digital model of the ulcer and surrounding tissue, with accompanying photographic documentation.
Patient Self-Scan: Participants will then be guided to perform a self-scan of their ulcer using the same TASHA platform, under clinical supervision. This is designed to evaluate usability, scan quality, and the potential for future unsupervised home-based scanning.
Remote Clinical Review: TASHA scan data will be de-identified and reviewed by a remote clinician who is blinded to the in-clinic findings. They will assess wound characteristics using a structured form equivalent to the in-person evaluation.
Optional Feedback Collection: Participants may optionally provide structured feedback regarding the ease of use, instructions clarity, and perceived difficulty of the scanning task.
Device Description
TASHA consists of:
A 3D scanning unit utilising structured light or depth-sensing technology A software platform for scan acquisition, data encryption, and transfer A secure clinician portal for visualising digital twins and conducting remote assessments The device is currently unmarked (not yet UK Conformity Assessed [UKCA] or Conformité Européenne [CE] certified) and is being evaluated solely under ethics-approved investigational use conditions.
Data Management and Analysis All identifiable data will be securely stored on encrypted NHS infrastructure and will not be accessed by the device developer. Anonymised data (including wound scans and structured assessment metadata) will be securely transferred to Medical Intelligence Group Ltd for performance evaluation and iterative development of the TASHA platform.
Data Handling:
Role-based access control and encryption will be implemented across all data storage systems Anonymisation will include removal of all identifiers prior to data export Data will not be shared, sold, or commercialised beyond internal research and regulatory preparation Primary data outputs will include ulcer size, surface area, depth estimation, infection markers (as visible), and scan metadata.
Planned Statistical Analysis Concordance analysis: Agreement between in-clinic and remote assessments will be assessed using Cohen's Kappa for categorical variables (e.g. ulcer stage) and Intraclass Correlation Coefficients (ICC) or Bland-Altman plots for continuous measures (e.g. ulcer size, depth).
Root Mean Square Error (RMSE): RMSE will be used to quantify measurement error between clinician and patient-generated scans, particularly for spatial metrics like ulcer area and volume.
Sensitivity and Specificity: The platform's ability to detect changes in ulcer condition (improvement, worsening, stability) will be calculated against in-clinic assessments as the reference standard.
Inter-rater Reliability: Multiple clinician reviewers (in-person and remote) will be compared to assess consistency in interpretation of TASHA scan data.
Descriptive Statistics: Demographics, ulcer characteristics, scan duration, and usability metrics (e.g. assistance required) will be summarised using basic descriptive statistics.
This analysis will inform future statistical powering and endpoint selection for a definitive trial.
Ethical and Regulatory Compliance This study has received ethics approval from a UK NHS Research Ethics Committee via the Integrated Research Application System (IRAS). It will be conducted in compliance with the UK Policy Framework for Health and Social Care Research, the Declaration of Helsinki, and Good Clinical Practice (GCP) guidelines.
Risk management and insurance:
NHS indemnity applies to any clinical care-related activity carried out by NHS-employed staff Medical Intelligence Group Ltd has secured commercial liability insurance for all device-related research risks and data processing activity No adverse events are anticipated, as the TASHA system is non-invasive and used solely to supplement standard care assessments.
Future Applications
Insights from this pilot study will be used to:
Validate the clinical utility of the TASHA platform Optimise usability features for patient-led scanning Support UKCA/CE marking and regulatory submissions Design a statistically powered, multi-site clinical investigation Enable remote wound monitoring capabilities within community and home settings
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with DFU | – | Other: Foot scanOnly 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foot scanThis does not constitute a intervention but all participants will undergo image scans of their ulcer | Other | Patients with DFU |
Primary outcome
Agreement in Ulcer Stage Classification Between Remote and In-Clinic Assessments
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
1 secondary outcome
Root Mean Square Error Between Clinician and Patient Self-Scans of Ulcer Surface Area
Time frame: At each clinical visit per participant, up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Individual participant dataSharing planned: Undecided. The type of data may be proprietary and may be linked to future studies
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Ulcer and Diabetic Foot Ulcer (DFU), run by Medical Intelligence Group at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sagar Jadeja, BDS, PhD, MFDS, AKC (+447923387582, sagar@mig-health.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement in Ulcer Stage Classification Between Remote and In-Clinic Assessments (time frame: Each clinical visit per patient unto 24 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.