FeetSee Thermal Images Collection Protocol in Diabetes Patients
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Helena Grinberg Rashi, Phd
- Phone Number: +31615636666
- Email: helena@diabetis.lt
Study Contact Backup
- Name: Rytis Zajančkauskas, MD
- Email: rytis@diabetis.lt
Study Locations
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Vilnius, Lithuania
- Recruiting
- Vilnius University Hospital Santaros Klinikos
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Contact:
- Laura Siauliene, Dr, MD
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Contact:
- Žydrūnė Visockienė, Prof., MD
- Email: zydrune.visockiene@santa.lt
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Blackpool, United Kingdom
- Not yet recruiting
- Blackpool Teaching Hospitals NHS Trust
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Contact:
- Eleanor Kidd
- Phone Number: +44 7511 768529
- Email: e.r.kidd1@lancaster.ac.uk
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Contact:
- Jonathan Lim, Dr, MD
- Email: jonathan.lim2@mft.nhs.uk
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Lancaster, United Kingdom
- Not yet recruiting
- Lancashire Teaching Hospitals NHS Foundation Trust
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Contact:
- Eleanor SC Kidd
- Email: e.r.kidd1@lancaster.ac.uk
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Manchester, United Kingdom
- Recruiting
- Manchester University NHS Foundation Trust (MFT)
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Contact:
- Eleanor SC Kidd
- Email: e.r.kidd1@lancaster.ac.uk
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Contact:
- Jonathan SI Lim, Dr, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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Proportion of enrolled participants who develop at least one new plantar diabetic foot ulcer (DFU) during the study follow-up.
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From baseline (enrolment) until study completion or development of a new DFU, up to 9 months per participant.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Neil Reeves, Prof, Phd, Manchester University NHS Foundation Trust (MFT)
- Principal Investigator: Loretta Vileikyte, Prof, MD, Lancashire Teaching Hospitals NHS Foundation Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FS-HRA_01-PR
- RAS ID [345382] (Other Identifier: The Integrated Research Application System (IRAS) , UK)
- 10-036-T-0004 (Other Grant/Funding Number: European Horizon Programme)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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