Diabetic Foot UlcerNCT07300163
FeetSee Thermal Images Collection Protocol in Diabetes Patients
An observational study of Diabetic Foot Ulcer, run by Diabetis JSC at 4 sites in 2 countries.
Trial summary
Diabetic foot ulcers (DFUs) are a major cause of morbidity, lower-extremity amputation and healthcare costs in people with diabetes. DFUs often develop without pain or warning symptoms because of diabetic peripheral neuropathy, so patients may not recognise early signs of tissue damage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- FeetSee thermal camera
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 100 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 16 Dec 2025to 30 May 2027
- 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: Adults (≥18 years) with type 1 or type 2 diabetes, a history of plantar diabetic foot ulcer(s) that have been fully healed for at least 6 weeks, clinical evidence of diabetic peripheral neuropathy, and at least one palpable foot pulse. This is a high-risk population for recurrent plantar diabetic foot ulceration, without active ulceration, active Charcot neuro-osteoarthropathy, severe peripheral arterial disease, or major lower-limb amputation (above metatarsophalangeal disarticulation).
Who may be able to join
- Males/females aged over 18 years.
- Type 1 or type 2 diabetes.
- History of plantar diabetic foot ulcer(s).
- Foot ulcer healed for at least 6 weeks before entry into study, as determined by a specialist healthcare provider.
- Presence of diabetic peripheral neuropathy defined by either of the following:
- Inability to detect the monofilament (10g) applied at two foot sites, including the apex of the Hallux (ADA guidelines 2008 Diabetes Care 31(1)).
- A Vibration Perception Threshold (VPT) >20V, and/or by inability to detect application of the monofilament at the apex of the Hallux.
- Presence of at least one palpable foot pulse.
Who cannot join
- Active foot ulceration.
- Active Charcot neuro-osteoarthropathy.
- Severe vascular disease (complete absence of any foot pulses).
- Lower limb/foot amputation greater than metatarsophalangeal disarticulation.
- Active malignancy, immunosuppressive disease.
- Physical or mental condition(s) that limit the ability to follow instructions for the study, based on clinical judgment by the physician, such as inability to use the device without assistance.
- Current participation in another clinical investigation of a medical device that is contraindicated for either study procedure/outcome.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Rytis Zajančkauskas, MD contact
4 sites in 2 countries
United Kingdom3 sites, 3 recruiting
- Not yet recruiting
Blackpool Teaching Hospitals NHS Trust
Blackpool
Eleanor Kidd, +44 7511 768529, e.r.kidd1@lancaster.ac.uk
Jonathan Lim, Dr, MD, jonathan.lim2@mft.nhs.uk
- Not yet recruiting
Lancashire Teaching Hospitals NHS Foundation Trust
Lancaster
Eleanor SC Kidd, e.r.kidd1@lancaster.ac.uk
- Recruiting
Manchester University NHS Foundation Trust (MFT)
Manchester
Eleanor SC Kidd, e.r.kidd1@lancaster.ac.uk
Jonathan SI Lim, Dr, MD
Lithuania1 site, 1 recruiting
- Recruiting
Vilnius University Hospital Santaros Klinikos
Vilnius
Žydrūnė Visockienė, Prof., MD, zydrune.visockiene@santa.lt
Laura Siauliene, Dr, MD
About this study
Official title: Foot Temperature and Diabetic Foot Ulcer Risk: Using the FeetSee Device to Generate a Unique Foot Temperature Dataset.
Diabetic foot ulcers (DFUs) are a major cause of morbidity, lower-extremity amputation and healthcare costs in people with diabetes. DFUs often develop without pain or warning symptoms because of diabetic peripheral neuropathy, so patients may not recognise early signs of tissue damage. Monitoring plantar foot skin temperature is a promising strategy to detect early "hot-spots" of inflammation that precede ulceration and could trigger timely preventive action.
This prospective, single-group study will enrol adults with type 1 or type 2 diabetes, a history of plantar DFU that has been healed for at least 6 weeks, and evidence of diabetic peripheral neuropathy. Participants will be recruited from hospital clinics in the United Kingdom and Lithuania. After a baseline assessment (including medical history and neuropathy testing), each participant will receive the FeetSee system, consisting of a thermal camera attached to their own smartphone or tablet, a stand, and the FeetSee mobile application.
Read more
Participants will be instructed to acquire thermal and optical images of both feet at home at least once per day for 6-9 months, or until a new DFU develops. Images will be uploaded securely to cloud storage, where the FeetSee algorithm will analyse temperature patterns, comparing mirrored regions of both feet to identify potential inflammatory "hot-spots" associated with DFU risk. Participants will continue to receive standard clinical care throughout the study.
The primary objective is to generate a longitudinal foot temperature dataset in this high-risk population and use it to retrospectively test and refine the FeetSee algorithm for predicting DFU occurrence. The primary outcome is the incidence of new DFUs during follow-up. Secondary objectives are to assess the feasibility and acceptability of daily device use (recruitment, retention, adherence, user and healthcare-provider questionnaires) and to document any device-related or system-related safety issues.
Read the detailed description
This is a prospective observational study with a single cohort of approximately 100 adults with type 1 or type 2 diabetes and a recently healed plantar DFU, conducted at hospital sites in the United Kingdom and at Vilnius University Hospital Santaros Klinikos in Lithuania. Eligibility requires peripheral neuropathy (defined by abnormal 10 g monofilament and/or vibration perception threshold testing) and at least one palpable foot pulse. Key exclusions include active DFU, active Charcot neuro-osteoarthropathy, severe peripheral arterial disease (no palpable foot pulses), major lower-limb amputation above the metatarsophalangeal joints, and medical or cognitive conditions that would prevent safe use of the device.
After informed consent and baseline assessments, participants are trained to use the FeetSee thermal camera, stand, and smartphone/tablet app at home. They are asked to remove footwear and socks and keep their feet non-weight-bearing for about 10 minutes before each measurement, then acquire at least one bilateral plantar image per day. Study staff provide intensive technical support during the first week and then schedule telephone check-ins approximately every three weeks, with additional troubleshooting as needed. Adherence is monitored via device-logged usage; failure to use the device for 21 consecutive days is considered loss to follow-up.
Thermal images are pseudo-anonymised and transferred securely to cloud infrastructure, where the FeetSee algorithm uses an active-shape model to detect foot contours and compares mirrored plantar regions for temperature differences above a predefined threshold (e.g.,>2.2 °C), indicative of local inflammation. The analyses performed by the device manufacturer (Diabetis JSC) will use the resulting temperature maps and clinical outcomes to estimate the sensitivity and specificity of the current algorithm for predicting incident DFUs and to develop refined algorithms. All other clinical and questionnaire data are analysed by the academic research team.
Feasibility outcomes include recruitment rate, retention, frequency of device use, and the number and nature of technical support contacts. Acceptance of the technology by both patients and healthcare professionals is assessed with questionnaires based on the Unified Theory of Acceptance and Use of Technology (UTAUT), covering performance expectancy, effort expectancy, social influence, facilitating conditions, self-efficacy, attitudes toward FeetSee, technology anxiety, and perceptions of personal DFU risk. Safety outcomes include the collection and classification of any adverse events and the identification of any device-related problems.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- FeetSee thermal camera
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FeetSee thermal cameraDevice
The FeetSee Device consists of: (1) a smartphone/tablet-connected thermal imaging camera, (2) a mobile application installed on the participant's own mobile device, and (3) a stand to hold the device in a fixed position for imaging. Participants are instructed to take at least one bilateral plantar thermal and optical image of their feet per day at home over 6-9 months. Images are securely uploaded to cloud storage. The device is used for thermal image collection and is not a replacement for standard diabetic foot self-examination and routine clinical foot care; no treatment decisions are mandated by the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| FeetSee Foot Monitoring Cohort | Adults with type 1 or type 2 diabetes, peripheral neuropathy, and a recently healed plantar diabetic foot ulcer will use the FeetSee System at home in addition to their usual diabetic foot care. After baseline clinical assessment and training, participants will be asked to acquire at least one thermal (and accompanying optical) image of the plantar surface of both feet per day using the FeetSee thermal camera, stand, and smartphone/tablet application over the follow-up period (approximately 6-9 months) or until a new diabetic foot ulcer develops. Images are uploaded securely for later analysis of plantar temperature patterns. No experimental drug or change in standard clinical management is mandated by the protocol; the device is used for image collection only. Receives: Device: FeetSee thermal camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFU occurrence over the six to nine-month follow-up period.
Proportion of enrolled participants who develop at least one new plantar diabetic foot ulcer (DFU) during the study follow-up.
Measured: From baseline (enrolment) until study completion or development of a new DFU, up to 9 months per participant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start16 Dec 2025
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diabetis JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Horizon 2020 - European Commission, Manchester University NHS Foundation Trust, Lancashire Teaching Hospitals NHS Foundation Trust, Vilnius University Hospital Santaros Klinikos
- Responsible party
- Sponsor
- Investigators
- Neil Reeves, Prof, Phd, Principal investigator, Manchester University NHS Foundation Trust (MFT)Loretta Vileikyte, Prof, MD, Principal investigator, Lancashire Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300163
- Sponsor's protocol ID
- FS-HRA_01-PR
- Other IDs
- RAS ID [345382], 10-036-T-0004
- Status last verified
- Dec 2025
- First submitted
- 10 Dec 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foot Temperature and Diabetic Foot Ulcer Risk: Using the FeetSee Device to Generate a Unique Foot Temperature Dataset.
- ClinicalTrials.gov ID
- NCT07300163
- Acronym / sponsor ID
- FS-HRA_01-PR
- Conditions
- Diabetic Foot Ulcer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Diabetis JSCIndustry (pharma, biotech, devices)
- Collaborators
- Horizon 2020 - European Commission, Manchester University NHS Foundation Trust, Lancashire Teaching Hospitals NHS Foundation Trust, Vilnius University Hospital Santaros Klinikos
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 23 Dec 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.
Diabetic foot ulcers (DFUs) are a major cause of morbidity, lower-extremity amputation and healthcare costs in people with diabetes. DFUs often develop without pain or warning symptoms because of diabetic peripheral neuropathy, so patients may not recognise early signs of tissue damage. Monitoring plantar foot skin temperature is a promising strategy to detect early "hot-spots" of inflammation that precede ulceration and could trigger timely preventive action.
This prospective, single-group study will enrol adults with type 1 or type 2 diabetes, a history of plantar DFU that has been healed for at least 6 weeks, and evidence of diabetic peripheral neuropathy. Participants will be recruited from hospital clinics in the United Kingdom and Lithuania. After a baseline assessment (including medical history and neuropathy testing), each participant will receive the FeetSee system, consisting of a thermal camera attached to their own smartphone or tablet, a stand, and the FeetSee mobile application.
Participants will be instructed to acquire thermal and optical images of both feet at home at least once per day for 6-9 months, or until a new DFU develops. Images will be uploaded securely to cloud storage, where the FeetSee algorithm will analyse temperature patterns, comparing mirrored regions of both feet to identify potential inflammatory "hot-spots" associated with DFU risk. Participants will continue to receive standard clinical care throughout the study.
The primary objective is to generate a longitudinal foot temperature dataset in this high-risk population and use it to retrospectively test and refine the FeetSee algorithm for predicting DFU occurrence. The primary outcome is the incidence of new DFUs during follow-up. Secondary objectives are to assess the feasibility and acceptability of daily device use (recruitment, retention, adherence, user and healthcare-provider questionnaires) and to document any device-related or system-related safety issues.
Detailed description
This is a prospective observational study with a single cohort of approximately 100 adults with type 1 or type 2 diabetes and a recently healed plantar DFU, conducted at hospital sites in the United Kingdom and at Vilnius University Hospital Santaros Klinikos in Lithuania. Eligibility requires peripheral neuropathy (defined by abnormal 10 g monofilament and/or vibration perception threshold testing) and at least one palpable foot pulse. Key exclusions include active DFU, active Charcot neuro-osteoarthropathy, severe peripheral arterial disease (no palpable foot pulses), major lower-limb amputation above the metatarsophalangeal joints, and medical or cognitive conditions that would prevent safe use of the device.
After informed consent and baseline assessments, participants are trained to use the FeetSee thermal camera, stand, and smartphone/tablet app at home. They are asked to remove footwear and socks and keep their feet non-weight-bearing for about 10 minutes before each measurement, then acquire at least one bilateral plantar image per day. Study staff provide intensive technical support during the first week and then schedule telephone check-ins approximately every three weeks, with additional troubleshooting as needed. Adherence is monitored via device-logged usage; failure to use the device for 21 consecutive days is considered loss to follow-up.
Thermal images are pseudo-anonymised and transferred securely to cloud infrastructure, where the FeetSee algorithm uses an active-shape model to detect foot contours and compares mirrored plantar regions for temperature differences above a predefined threshold (e.g.,>2.2 °C), indicative of local inflammation. The analyses performed by the device manufacturer (Diabetis JSC) will use the resulting temperature maps and clinical outcomes to estimate the sensitivity and specificity of the current algorithm for predicting incident DFUs and to develop refined algorithms. All other clinical and questionnaire data are analysed by the academic research team.
Feasibility outcomes include recruitment rate, retention, frequency of device use, and the number and nature of technical support contacts. Acceptance of the technology by both patients and healthcare professionals is assessed with questionnaires based on the Unified Theory of Acceptance and Use of Technology (UTAUT), covering performance expectancy, effort expectancy, social influence, facilitating conditions, self-efficacy, attitudes toward FeetSee, technology anxiety, and perceptions of personal DFU risk. Safety outcomes include the collection and classification of any adverse events and the identification of any device-related problems.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FeetSee Foot Monitoring Cohort | – | Device: FeetSee thermal cameraAdults with type 1 or type 2 diabetes, peripheral neuropathy, and a recently healed plantar diabetic foot ulcer will use the FeetSee System at home in addition to their usual diabetic foot care. After baseline clinical assessment and training, participants will be asked to acquire at least one thermal (and accompanying optical) image of the plantar surface of both feet per day using the FeetSee thermal camera, stand, and smartphone/tablet application over the follow-up period (approximately 6-9 months) or until a new diabetic foot ulcer develops. Images are uploaded securely for later analysis of plantar temperature patterns. No experimental drug or change in standard clinical management is mandated by the protocol; the device is used for image collection only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (≥18 years) with type 1 or type 2 diabetes, a history of plantar diabetic foot ulcer(s) that have been fully healed for at least 6 weeks, clinical evidence of diabetic peripheral neuropathy, and at least one palpable foot pulse. This is a high-risk population for recurrent plantar diabetic foot ulceration, without active ulceration, active Charcot neuro-osteoarthropathy, severe peripheral arterial disease, or major lower-limb amputation (above metatarsophalangeal disarticulation).
Key inclusion criteria (8 listed)
- Males/females aged over 18 years.
- Type 1 or type 2 diabetes.
- History of plantar diabetic foot ulcer(s).
- Foot ulcer healed for at least 6 weeks before entry into study, as determined by a specialist healthcare provider.
- Presence of diabetic peripheral neuropathy defined by either of the following:
Key exclusion criteria (7 listed)
- Active foot ulceration.
- Active Charcot neuro-osteoarthropathy.
- Severe vascular disease (complete absence of any foot pulses).
- Lower limb/foot amputation greater than metatarsophalangeal disarticulation.
- Active malignancy, immunosuppressive disease.
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 |
|---|---|---|
| FeetSee thermal cameraThe FeetSee Device consists of: (1) a smartphone/tablet-connected thermal imaging camera, (2) a mobile application installed on the participant's own mobile device, and (3) a stand to hold the device in a fixed position for imaging. Participants are instructed to take at least one bilateral plantar thermal and optical image of their feet per day at home over 6-9 months. Images are securely uploaded to cloud storage. The device is used for thermal image collection and is not a replacement for standard diabetic foot self-examination and routine clinical foot care; no treatment decisions are mandated by the study protocol. | Device | FeetSee Foot Monitoring Cohort |
Primary outcome
DFU occurrence over the six to nine-month follow-up period.
Time frame: From baseline (enrolment) until study completion or development of a new DFU, up to 9 months per participant.
Proportion of enrolled participants who develop at least one new plantar diabetic foot ulcer (DFU) during the study follow-up.
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 22 Jun 2026.
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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.
Rytis Zajančkauskas, MD contact
Neil Reeves, Prof, Phd principal investigator
Manchester University NHS Foundation Trust (MFT)
Loretta Vileikyte, Prof, MD principal investigator
Lancashire Teaching Hospitals NHS Foundation Trust
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Ulcer, run by Diabetis JSC at 4 sites in 2 countries.
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 8 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: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom, 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?
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 Helena Grinberg Rashi, Phd (+31615636666, helena@diabetis.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFU occurrence over the six to nine-month follow-up period. (time frame: From baseline (enrolment) until study completion or development of a new DFU, up to 9 months per participant.). 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 22 Jun 2026.