Diabetic FootNCT05222490
FeetSee Thermal Images Collection Protocol
A study testing Thermal Camera images acquisition - FeetSee and Thermal Camera images acquisition - Reference in people with Diabetic Foot, run by Diabetis JSC at 1 site in Lithuania.
Trial summary
The purpose of this study is to collect thermal images of diabetic patients' feet to evaluate the performance of Feetsee - foot monitoring device for periodic evaluation of the temperature over the soles of the feet for signs of inflammation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- Thermal Camera images acquisition - FeetSee and Thermal Camera images acquisition - Reference
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteLithuania
- Study dates
- 13 Jul 2021to 28 Feb 2022
- 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
- Group 1/2: Diabetic with/without ulcers
- Male/Female, 18 years or older
- Diagnosis of type 1 or type 2 Diabetes Mellitus, confirmed by a family physician or an endocrinologist.
- Patient with or without history of previous foot ulcer, confirmed by a family physician or an endocrinologist
- For Group 1: Patient with diabetic foot and ulceration diagnosed/confirmed by the study physician on the day of enrollment For Group 2: Patient without ulcers diagnosed/confirmed by the study physician on the day of enrollment
- Must be able to read, understand and sign the Informed Consent Form Control: Generally Healthy Non-diabetic
- 1. Male/Female, 18 years or older 2. No diabetes mellitus or other diseases that may have signs of polyneuropathy or impaired blood circulation in the foot. 3.No damage to the skin or the soft tissues of the examined feet. 4. Must be able to read, understand and sign the Informed Consent Form
Who cannot join
- Critical ischemia and/or deep ulceration (grades 4 or 5 according to Texas grading system).
- Active Infection/Gangrene
- Active malignancy
- Immunosuppressive disease
- History of alcohol or drug abuse
- Pregnant women (verbal confirmation or confirmation obtained within current medical records)
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- Cognitive deficit
- End-stage renal disease
- History of amputation proximal to the Trans-metatarsal (TM) joint
- Other issues that, at the discretion of the investigator, renders the subject ineligible for participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Collection of the Thermal Images of Diabetic Patients' Feet for FeetSee Device Performance Evaluation
The purpose of this study is to collect thermal images of diabetic patients' feet to evaluate the performance of Feetsee - foot monitoring device for periodic evaluation of the temperature over the soles of the feet for signs of inflammation.
Read the detailed description
The aim of this study is to collect a database of thermal images of the diabetic persons' feet, and non-diabetic control groups' feet images, which in turn will enable us to build a system based on a mobile thermal camera and a mobile application for possible indication of signs of inflammation in feet. Enrolled participants will undergo a detailed history and physical examination of the foot at the beginning of the procedure day. Then the thermal images of the patient's feet will be taken. Participants will be also asked to take thermal images of their feet according to very well-explained instructions provided by the sponsor. Thermal images using the reference thermal camera will be taken following the Feetsee thermal camera. The images will be unidentified, collected, and stored for the development and performance evaluation of the Feetsee device Algorithm. At the end of the study procedure, participants or their caregivers will receive a short questioner on their experience with using the study device.
- Conditions
- Diabetic Foot
- Being tested
- Thermal Camera images acquisition - FeetSee, Thermal Camera images acquisition - Reference
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal Camera images acquisition - FeetSeeDevice
Thermal images will be collected according to the instructions for use of the Feetsee device.
Thermal Camera images acquisition - ReferenceDevice
After 15 minutes of resting, thermal images from the reference device will be collected according to their manufacturer
| Study group | Role | What they receive |
|---|---|---|
| Diabetic with Ulcers | Experimental | Patient with diabetic foot and ulceration diagnosed/confirmed by the study physician on the day of enrollment Receives: Device: Thermal Camera images acquisition - FeetSee; Device: Thermal Camera images acquisition - Reference |
| Diabetic without Ulcers | Experimental | Patient without ulcers diagnosed/confirmed by the study physician on the day of enrollment Receives: Device: Thermal Camera images acquisition - FeetSee; Device: Thermal Camera images acquisition - Reference |
| Control | Active comparator | Generally Healthy Non-diabetic Subjects Receives: Device: Thermal Camera images acquisition - FeetSee; Device: Thermal Camera images acquisition - Reference |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate of a difference in temperature between two feet per subject
The primary outcome of this study is collecting of adequate thermal images from study groups' individuals using Feetsee device in order to develop and evaluate its performance to detect a temperature difference between two foot as a potential sign of inflammation and compare the camera performance to the reference camera.
Measured: through study completion, on average within of 1 year
Secondary outcomes (1)
To evaluate the usability of FeeSee device by patient and healthcare providers
The evaluation of Feetsee device usability by patients or their healthcare providers using a a dedicated usability questioner.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start13 Jul 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diabetis JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05222490
- Sponsor's protocol ID
- RD-FS-01
- Status last verified
- Nov 2021
- First submitted
- 25 Nov 2021
- Last updated
- 13 Aug 2024
- 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 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of the Thermal Images of Diabetic Patients' Feet for FeetSee Device Performance Evaluation
- ClinicalTrials.gov ID
- NCT05222490
- Acronym / sponsor ID
- RD-FS-01
- Conditions
- Diabetic Foot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Diabetis JSCIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 3 Feb 2022 (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 purpose of this study is to collect thermal images of diabetic patients' feet to evaluate the performance of Feetsee - foot monitoring device for periodic evaluation of the temperature over the soles of the feet for signs of inflammation.
Detailed description
The aim of this study is to collect a database of thermal images of the diabetic persons' feet, and non-diabetic control groups' feet images, which in turn will enable us to build a system based on a mobile thermal camera and a mobile application for possible indication of signs of inflammation in feet. Enrolled participants will undergo a detailed history and physical examination of the foot at the beginning of the procedure day. Then the thermal images of the patient's feet will be taken. Participants will be also asked to take thermal images of their feet according to very well-explained instructions provided by the sponsor. Thermal images using the reference thermal camera will be taken following the Feetsee thermal camera. The images will be unidentified, collected, and stored for the development and performance evaluation of the Feetsee device Algorithm. At the end of the study procedure, participants or their caregivers will receive a short questioner on their experience with using the study device.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diabetic with Ulcers | Experimental | Device: Thermal Camera images acquisition - FeetSee, Device: Thermal Camera images acquisition - ReferencePatient with diabetic foot and ulceration diagnosed/confirmed by the study physician on the day of enrollment |
| Diabetic without Ulcers | Experimental | Device: Thermal Camera images acquisition - FeetSee, Device: Thermal Camera images acquisition - ReferencePatient without ulcers diagnosed/confirmed by the study physician on the day of enrollment |
| Control | Active comparator | Device: Thermal Camera images acquisition - FeetSee, Device: Thermal Camera images acquisition - ReferenceGenerally Healthy Non-diabetic Subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Group 1/2: Diabetic with/without ulcers
- Male/Female, 18 years or older
- Diagnosis of type 1 or type 2 Diabetes Mellitus, confirmed by a family physician or an endocrinologist.
- Patient with or without history of previous foot ulcer, confirmed by a family physician or an endocrinologist
- For Group 1: Patient with diabetic foot and ulceration diagnosed/confirmed by the study physician on the day of enrollment For Group 2: Patient without ulcers diagnosed/confirmed by the study physician on the day of enrollment
Key exclusion criteria (10 listed)
- Critical ischemia and/or deep ulceration (grades 4 or 5 according to Texas grading system).
- Active Infection/Gangrene
- Active malignancy
- Immunosuppressive disease
- History of alcohol or drug abuse
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 |
|---|---|---|
| Thermal Camera images acquisition - FeetSeeThermal images will be collected according to the instructions for use of the Feetsee device. | Device | Control, Diabetic with Ulcers, Diabetic without Ulcers |
| Thermal Camera images acquisition - ReferenceAfter 15 minutes of resting, thermal images from the reference device will be collected according to their manufacturer | Device | Control, Diabetic with Ulcers, Diabetic without Ulcers |
Primary outcome
Estimate of a difference in temperature between two feet per subject
Time frame: through study completion, on average within of 1 year
The primary outcome of this study is collecting of adequate thermal images from study groups' individuals using Feetsee device in order to develop and evaluate its performance to detect a temperature difference between two foot as a potential sign of inflammation and compare the camera performance to the reference camera.
1 secondary outcome
To evaluate the usability of FeeSee device by patient and healthcare providers
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- 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 Thermal Camera images acquisition - FeetSee and Thermal Camera images acquisition - Reference in people with Diabetic Foot, run by Diabetis JSC at 1 site in Lithuania.
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 7 inclusion and 10 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: finished, as of the sponsor's last update on 13 Aug 2024. 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 Lithuania. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Estimate of a difference in temperature between two feet per subject (time frame: through study completion, on average within of 1 year). 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 13 Aug 2024.