FeetSee Thermal Images Collection Protocol in Diabetes Patients

NCT ID: NCT07300163

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-10
• Study Completion Date: 2027-05-30

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

FeetSee thermal camera

Intervention Type: 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.

Interventions

FeetSee thermal camera

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Horizon 2020 - European Commission

OTHER

Sponsor Role: collaborator

Manchester University NHS Foundation Trust

OTHER_GOV

Sponsor Role: collaborator

Lancashire Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Vilnius University Hospital Santaros Klinikos

OTHER

Sponsor Role: collaborator

Diabetis JSC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neil Reeves, Prof, Phd

Role: PRINCIPAL_INVESTIGATOR

Manchester University NHS Foundation Trust (MFT)

Loretta Vileikyte, Prof, MD

Role: PRINCIPAL_INVESTIGATOR

Lancashire Teaching Hospitals NHS Foundation Trust

Locations

Vilnius University Hospital Santaros Klinikos

Vilnius, , Lithuania

Lancashire Teaching Hospitals NHS Foundation Trust

Lancaster, , United Kingdom

Manchester University NHS Foundation Trust (MFT)

Manchester, , United Kingdom

Countries

Lithuania; United Kingdom

Central Contacts

Helena Grinberg Rashi, Phd

Role: CONTACT

Phone: +31615636666

Email: helena@diabetis.lt

Rytis Zajančkauskas, MD

Role: CONTACT

Email: rytis@diabetis.lt

Facility Contacts

Žydrūnė Visockienė, Prof., MD

Role: primary

Laura Siauliene, Dr, MD

Role: backup

Eleanor SC Kidd

Role: primary

Eleanor SC Kidd

Role: primary

Jonathan SI Lim, Dr, MD

Role: backup

Other Identifiers

RAS ID [345382]

Identifier Type: OTHER

Identifier Source: secondary_id

10-036-T-0004

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

FS-HRA_01-PR

Identifier Type: -

Identifier Source: org_study_id