FeetSee Thermal Images Collection Protocol

Diabetis JSC

Status: Completed

Conditions: Diabetic Foot

Treatments: Device: Thermal Camera images acquisition - FeetSee; Device: Thermal Camera images acquisition - Reference

Study type: Interventional

Funder types: Industry

Identifiers

NCT05222490

RD-FS-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

6. 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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 3 patient groups

Diabetic with Ulcers

Experimental group

Description:

Patient with diabetic foot and ulceration diagnosed/confirmed by the study physician on the day of enrollment

Treatment:

Device: Thermal Camera images acquisition - Reference

Device: Thermal Camera images acquisition - FeetSee

Diabetic without Ulcers

Experimental group

Description:

Patient without ulcers diagnosed/confirmed by the study physician on the day of enrollment

Treatment:

Device: Thermal Camera images acquisition - Reference

Device: Thermal Camera images acquisition - FeetSee

Control

Active Comparator group

Description:

Generally Healthy Non-diabetic Subjects

Treatment:

Device: Thermal Camera images acquisition - Reference

Device: Thermal Camera images acquisition - FeetSee