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Home thermal camera images of the feet in people with diabetic foot ulcer history

Collects daily foot temperature images at home from people with healed diabetic foot ulcers.

Key facts

Who runs it
Diabetis JSC
Where
Lithuania and United Kingdom4 sites in 2 countriesChoose a country to see its sites
Trial code
Registry title
FeetSee Thermal Images Collection Protocol in Diabetes Patients
Status
Recruiting
People taking part
100 people, planned
Started
16 Dec 2025
Expected to end
30 May 2027
Type of study
Observational
Treatments tested
  • FeetSee thermal camera
Record updated
22 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with type 1 or type 2 diabetes and nerve damage in the feet who had a foot ulcer on the sole that has healed. They will take daily heat (thermal) pictures of their feet at home.

Age
Over 18 years.
Sex
Men and women can join.
Disease stage
A past ulcer on the sole of the foot, healed for at least 6 weeks, as confirmed by a specialist. Nerve damage from diabetes (diabetic peripheral neuropathy) must be present. At least one foot pulse must be felt.
Biomarker or test result
Nerve damage shown by not feeling a 10g monofilament at two foot sites, including the tip of the big toe. Or a Vibration Perception Threshold (VPT) >20V, and/or not feeling the monofilament at the tip of the big toe.

Main reasons for not taking part

  • An open foot ulcer now, or active Charcot foot (a nerve-related bone and joint disease).
  • Severe blood vessel disease, with no foot pulse felt at all.
  • Leg or foot amputation larger than removal of a toe at its base joint.
  • Active cancer or a disease that weakens the immune system.
  • Being unable to follow study instructions or use the device without help.

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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 take part

  • Severe vascular disease (complete absence of any foot pulses)
  • 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
  • Active foot ulceration
  • Active Charcot neuro-osteoarthropathy
  • Lower limb/foot amputation greater than metatarsophalangeal disarticulation
  • Current participation in another clinical investigation of a medical device that is contraindicated for either study procedure/outcome

This trial has no sites in United States.

It has sites in 2 countries. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The group in the trial

  • 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.

    Treatment: FeetSee thermal camera

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Foot Temperature and Diabetic Foot Ulcer Risk: Using the FeetSee Device to Generate a Unique Foot Temperature Dataset.
Plain-language title
Home thermal camera images of the feet in people with diabetic foot ulcer historyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Record updated
22 June 2026