FeetSee Thermal Images Collection Protocol in Diabetes Patients

NCT07300163 | Not Yet Recruiting DMC FDA Device

• 3 other identifiers: FS-HRA_01-PRRAS ID [345382]10-036-T-0004
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 3

Brief 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. 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.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline (enrolment) until study completion or development of a new DFU, up to 9 months per participant.

Study Arms (1)

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.

Device: FeetSee thermal camera

Interventions

FeetSee thermal camera DEVICE

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.

FeetSee Foot Monitoring Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Diabetis JSC: lead
• Horizon 2020 - European Commission: collaborator
• Manchester University NHS Foundation Trust: collaborator
• Vilnius University Hospital Santaros Klinikos: collaborator
• Lancashire Teaching Hospitals NHS Foundation Trust: collaborator

Study Sites (3)

Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania

Location

Lancashire Teaching Hospitals NHS Foundation Trust

Lancaster, United Kingdom

Location

Manchester University NHS Foundation Trust (MFT)

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Neil Reeves, Prof, Phd

  Manchester University NHS Foundation Trust (MFT)

  PRINCIPAL INVESTIGATOR

• Loretta Vileikyte, Prof, MD

  Lancashire Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helena Grinberg Rashi, Phd

CONTACT

+31615636666; helena@diabetis.lt

Rytis Zajančkauskas, MD

CONTACT

rytis@diabetis.lt

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 23, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

GB (2); LI (1)