Foot Ulcer, DiabeticNCT06032221
Study to Determine the Feasibility of Using an At-home Foot Temperature Monitoring Device (Thermidas)
A study testing Thermidas Vista Telehealth App in people with Foot Ulcer, Diabetic, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
This is a feasibility study, designed to assess the acceptability of At Home Temperature Monitoring (AITM) by patients at high risk of diabetes foot ulceration. The investigation hopes to identify any problems with the study design before progressing to a full-scale evaluation, and will assess the ease of use of the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Foot Ulcer, Diabetic
- What is being tested?
- Thermidas Vista Telehealth App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jul 2023to 6 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent
- Male or Female >/ = 18 years of age
- Diabetes Mellitus type 1 or 2 according to WHO criteria
- independently ambulatory
- deemed high risk/ in remission via SCI diabetes foot risk stratification tool
- expected to comply with study schedule
Who cannot join
- active foot ulcer or open amputation site
- active Charcot Neuro-osteoarthropathy
- active foot infection based on PEDIS classification criteria
- amputation proximal to the Chopart joint in one or both feet
- critical limb ischaemia (according to PEDIS classification)
- severe illness that would make 6-month survival unlikely based on the clinical judgement of the physician or podiatrist
- concomitant severe physical or mental conditions that limit the ability to follow the instructions of the study, based on the clinical judgement of the physician or podiatrist
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Elizabeth University Hospital
Glasgow, Glasgow, G51 4TF
About this study
Official title: A Feasibility Study Assessing the Impact of At-home Infrared Temperature Monitoring (AITM) With Telemedicine Support in the Management of Patients With Potential for Diabetes Foot Ulceration
This is a feasibility study, designed to assess the acceptability of At Home Temperature Monitoring (AITM) by patients at high risk of diabetes foot ulceration. The investigation hopes to identify any problems with the study design before progressing to a full-scale evaluation, and will assess the ease of use of the technology and if there are any barriers to using this.
Participants will be provided with an infrared camera and SMART phone and trained in how to use them. The participants will then be expected to capture images of both the plantar and dorsal aspects of their feet that will be sent to the research team for review. The two images will be captured once per day. The Intervention period will be 12 weeks.
If a raised temperature is identified, the participant will be offered a face to face review appointment where they will receive podiatry treatment (if required), ulcer prevention advice and more detailed thermal imaging. Patient and health care professional (HCP) questionnaires will be used at the start and end of the study period to assess quality of life impact and device ease of use.
- Conditions
- Foot Ulcer, Diabetic
- Being tested
- Thermidas Vista Telehealth App
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermidas Vista Telehealth AppDevice
Thermal camera with telemedicine app
| Study group | Role | What they receive |
|---|---|---|
| device feasibility | Other | All participants issued with Thermidas device Receives: Device: Thermidas Vista Telehealth App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Feasibility - Completion
Participants successful completion of 12 weeks (percentage of all subjects who were enrolled in the study with ≥70% considered successful target (21 patients). This will assess if usage of the device on a daily basis over a specific period of time is practical
Measured: 12 weeks
Device Feasibility - Withdrawal
Participants withdrawal (Percentage of all subjects who were enrolled in the study ≤30% considered successful target). A low withdrawal rate will demonstrate that usage of the device is practical over the time period
Measured: 12 weeks
Device Feasibility - Compliance
No submission of images - i.e. no image submissions for 7-consecutive days on 2-occasions, generating 2-alerts over 12 weeks (absolute number of 'no submission' alerts). A lack of compliance with the study protocol will demonstrate low feasibility for regular device usage
Measured: 12 weeks
Device Feasibility - Safety
Incidence of Serious adverse events (SAEs) and Adverse device reactions (ADRs)
Measured: 12 weeks
Device Feasibility - Quality of life (QoL) utilising EQ-5D-5L instrument
Patient completion of EQ-5D-5L health utility score to obtain a health utility score at Baseline and at Week 12 (target 80% completion).
(The EQ-5D-5L descriptive system comprises the same five dimensions as the EQ-5D-3L (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION), but each dimension now has five response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. The respondent is asked to indicate his/her health state by checking the box next to the most appropriate response level for each)
Measured: 12 weeks
Device Feasibility - Health Economics
Health care utilisation and costs. The podiatrists will keep a log of time spent checking images and additional appointments generated in response to alerts. Costs will be calculated using staff time x staff payment costs
Measured: 12 weeks
Device Feasibility - Staff feedback on device use
A focus group meeting with podiatrists will be scheduled at the end of the participant data collection period to obtain qualitative data relating to device use.
Measured: 12 weeks
Device Feasibility - Patient feedback on device use
Patient completion of User Questionnaire Form (Week 12) (target 80% completion)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start14 Jul 2023
- Primary completion6 Feb 2025
- Study completion6 Feb 2025
Why it stopped: Delays in device modifications. Unable to complete within MHRA timescale
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot Ulcer, DiabeticStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The purpose of the study is to determine if the Thermidas camera with telemedicine app is a feasible device in the 2 patient cohorts (15 patients who have had previous diabetes foot ulceration and 15 patients who are deemed to be high risk of foot ulceration)
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- Robertson Centre for Biostatistics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032221
- Sponsor's protocol ID
- INGN21DI185
- Status last verified
- Feb 2025
- First submitted
- 22 Aug 2023
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study Assessing the Impact of At-home Infrared Temperature Monitoring (AITM) With Telemedicine Support in the Management of Patients With Potential for Diabetes Foot Ulceration
- ClinicalTrials.gov ID
- NCT06032221
- Acronym / sponsor ID
- INGN21DI185
- Conditions
- Foot Ulcer, Diabetic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Delays in device modifications. Unable to complete within MHRA timescale
- Enrolment
- 15 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- Robertson Centre for Biostatistics
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- 6 Feb 2025 (actual)
- Study completion
- 6 Feb 2025 (actual)
- First posted
- 11 Sep 2023 (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.
This is a feasibility study, designed to assess the acceptability of At Home Temperature Monitoring (AITM) by patients at high risk of diabetes foot ulceration. The investigation hopes to identify any problems with the study design before progressing to a full-scale evaluation, and will assess the ease of use of the technology and if there are any barriers to using this.
Participants will be provided with an infrared camera and SMART phone and trained in how to use them. The participants will then be expected to capture images of both the plantar and dorsal aspects of their feet that will be sent to the research team for review. The two images will be captured once per day. The Intervention period will be 12 weeks.
If a raised temperature is identified, the participant will be offered a face to face review appointment where they will receive podiatry treatment (if required), ulcer prevention advice and more detailed thermal imaging. Patient and health care professional (HCP) questionnaires will be used at the start and end of the study period to assess quality of life impact and device ease of use.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The purpose of the study is to determine if the Thermidas camera with telemedicine app is a feasible device in the 2 patient cohorts (15 patients who have had previous diabetes foot ulceration and 15 patients who are deemed to be high risk of foot ulceration)
| Arm | Type | Receives |
|---|---|---|
| device feasibility | Other | Device: Thermidas Vista Telehealth AppAll participants issued with Thermidas device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent
- Male or Female >/ = 18 years of age
- Diabetes Mellitus type 1 or 2 according to WHO criteria
- independently ambulatory
- deemed high risk/ in remission via SCI diabetes foot risk stratification tool
Key exclusion criteria (7 listed)
- active foot ulcer or open amputation site
- active Charcot Neuro-osteoarthropathy
- active foot infection based on PEDIS classification criteria
- amputation proximal to the Chopart joint in one or both feet
- critical limb ischaemia (according to PEDIS classification)
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 |
|---|---|---|
| Thermidas Vista Telehealth AppThermal camera with telemedicine app | Device | device feasibility |
Primary outcome
Device Feasibility - Completion
Time frame: 12 weeks
Participants successful completion of 12 weeks (percentage of all subjects who were enrolled in the study with ≥70% considered successful target (21 patients). This will assess if usage of the device on a daily basis over a specific period of time is practical
Device Feasibility - Withdrawal
Time frame: 12 weeks
Participants withdrawal (Percentage of all subjects who were enrolled in the study ≤30% considered successful target). A low withdrawal rate will demonstrate that usage of the device is practical over the time period
Device Feasibility - Compliance
Time frame: 12 weeks
No submission of images - i.e. no image submissions for 7-consecutive days on 2-occasions, generating 2-alerts over 12 weeks (absolute number of 'no submission' alerts). A lack of compliance with the study protocol will demonstrate low feasibility for regular device usage
Device Feasibility - Safety
Time frame: 12 weeks
Incidence of Serious adverse events (SAEs) and Adverse device reactions (ADRs)
Device Feasibility - Quality of life (QoL) utilising EQ-5D-5L instrument
Time frame: 12 weeks
Patient completion of EQ-5D-5L health utility score to obtain a health utility score at Baseline and at Week 12 (target 80% completion). (The EQ-5D-5L descriptive system comprises the same five dimensions as the EQ-5D-3L (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION), but each dimension now has five response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. The respondent is asked to indicate his/her health state by checking the box next to the most appropriate response level for each)
Device Feasibility - Health Economics
Time frame: 12 weeks
Health care utilisation and costs. The podiatrists will keep a log of time spent checking images and additional appointments generated in response to alerts. Costs will be calculated using staff time x staff payment costs
Device Feasibility - Staff feedback on device use
Time frame: 12 weeks
A focus group meeting with podiatrists will be scheduled at the end of the participant data collection period to obtain qualitative data relating to device use.
Device Feasibility - Patient feedback on device use
Time frame: 12 weeks
Patient completion of User Questionnaire Form (Week 12) (target 80% completion)
Results and safety
The study was stopped early (reason given: Delays in device modifications. Unable to complete within MHRA timescale). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermidas Vista Telehealth App in people with Foot Ulcer, Diabetic, run by NHS Greater Glasgow and Clyde 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 7 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: stopped early, as of the sponsor's last update on 5 Aug 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?
The study was stopped early (reason given: Delays in device modifications. Unable to complete within MHRA timescale). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Feasibility - Completion (time frame: 12 weeks). The study lists 8 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 5 Aug 2025.