Clinical trial NCT05222490: FeetSee Thermal Images Collection Protocol
Official title: Collection of the Thermal Images of Diabetic Patients' Feet for FeetSee Device Performance Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot
Lead sponsor: Diabetis JSC
Sponsor class: INDUSTRY
First posted: 2022-02-03
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to collect thermal images of diabetic patients' feet to evaluate the performance of Feetsee - foot monitoring device for periodic evaluation of the temperature over the soles of the feet for signs of inflammation.

Detailed description: The aim of this study is to collect a database of thermal images of the diabetic persons' feet, and non-diabetic control groups' feet images, which in turn will enable us to build a system based on a mobile thermal camera and a mobile application for possible indication of signs of inflammation in feet. Enrolled participants will undergo a detailed history and physical examination of the foot at the beginning of the procedure day. Then the thermal images of the patient's feet will be taken. Participants will be also asked to take thermal images of their feet according to very well-explained instructions provided by the sponsor. Thermal images using the reference thermal camera will be taken following the Feetsee thermal camera. The images will be unidentified, collected, and stored for the development and performance evaluation of the Feetsee device Algorithm. At the end of the study procedure, participants or their caregivers will receive a short questioner on their experience with using the study device.

Eligibility criteria: Inclusion Criteria:

Inclusion Criteria

Group 1/2: Diabetic with/without ulcers

1. Male/Female, 18 years or older
2. Diagnosis of type 1 or type 2 Diabetes Mellitus, confirmed by a family physician or an endocrinologist.
3. Patient with or without history of previous foot ulcer, confirmed by a family physician or an endocrinologist
4. For Group 1: Patient with diabetic foot and ulceration diagnosed/confirmed by the study physician on the day of enrollment For Group 2: Patient without ulcers diagnosed/confirmed by the study physician on the day of enrollment
5. Must be able to read, understand and sign the Informed Consent Form Control: Generally Healthy Non-diabetic

1. Male/Female, 18 years or older 2. No diabetes mellitus or other diseases that may have signs of polyneuropathy or impaired blood circulation in the foot. 3.No damage to the skin or the soft tissues of the examined feet. 4. Must be able to read, understand and sign the Informed Consent Form

Exclusion Criteria:

1. Critical ischemia and/or deep ulceration (grades 4 or 5 according to Texas grading system).
2. Active Infection/Gangrene
3. Active malignancy
4. Immunosuppressive disease
5. History of alcohol or drug abuse
6. Pregnant women (verbal confirmation or confirmation obtained within current medical records)
7. Cognitive deficit
8. End-stage renal disease
9. History of amputation proximal to the Trans-metatarsal (TM) joint
10. Other issues that, at the discretion of the investigator, renders the subject ineligible for participation.

Primary outcomes:
measure: Estimate of a difference in temperature between two feet per subject
timeFrame: through study completion, on average within of 1 year
Secondary outcomes:
measure: To evaluate the usability of FeeSee device by patient and healthcare providers
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Inlita Santara CTC
Study officials:
References: