FeetSee Thermal Images Collection Protocol

Not Applicable

Completed

• Conditions: Diabetic Foot
• Interventions: Device: Thermal Camera images acquisition - FeetSee; Device: Thermal Camera images acquisition - Reference

• Registration Number: NCT05222490
• Lead Sponsor: Diabetis JSC

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.

Study Timeline

• Study Start: 2021-07-13
• Status Verified: 2021-11
• Study First Submitted: 2021-11-25
• Study First Submitted QC: 2022-01-22
• Study First Posted: 2022-02-03
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diabetic with Ulcers	Thermal Camera images acquisition - Reference	Patient with diabetic foot and ulceration diagnosed/confirmed by the study physician on the day of enrollment
Diabetic without Ulcers	Thermal Camera images acquisition - Reference	Patient without ulcers diagnosed/confirmed by the study physician on the day of enrollment
Control	Thermal Camera images acquisition - FeetSee	Generally Healthy Non-diabetic Subjects
Control	Thermal Camera images acquisition - Reference	Generally Healthy Non-diabetic Subjects
Diabetic with Ulcers	Thermal Camera images acquisition - FeetSee	Patient with diabetic foot and ulceration diagnosed/confirmed by the study physician on the day of enrollment
Diabetic without Ulcers	Thermal Camera images acquisition - FeetSee	Patient without ulcers diagnosed/confirmed by the study physician on the day of enrollment

Primary Outcome Measures

Name	Time	Method
Estimate of a difference in temperature between two feet per subject	through study completion, on average within of 1 year	The primary outcome of this study is collecting of adequate thermal images from study groups' individuals using Feetsee device in order to develop and evaluate its performance to detect a temperature difference between two foot as a potential sign of inflammation and compare the camera performance to the reference camera.

Secondary Outcome Measures

Name	Time	Method
To evaluate the usability of FeeSee device by patient and healthcare providers	through study completion, an average of 1 year	The evaluation of Feetsee device usability by patients or their healthcare providers using a a dedicated usability questioner.

Trial Locations

Locations (1)

Inlita Santara CTC; 🇱🇹 Vilnius, Lithuania