FeetSee Thermal Images Collection Protocol

Collection of the Thermal Images of Diabetic Patients' Feet for FeetSee Device Performance Evaluation

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot
• Intervention / Treatment: Device: Thermal Camera images acquisition - FeetSee; Device: Thermal Camera images acquisition - Reference

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 Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lithuania
  • Vilnius, Lithuania
    • Inlita Santara CTC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diabetic with Ulcers; Patient with diabetic foot and ulceration diagnosed/confirmed by the study physician on the day of enrollment	Device: Thermal Camera images acquisition - FeetSee; Thermal images will be collected according to the instructions for use of the Feetsee device.; Device: Thermal Camera images acquisition - Reference; After 15 minutes of resting, thermal images from the reference device will be collected according to their manufacturer
Experimental: Diabetic without Ulcers; Patient without ulcers diagnosed/confirmed by the study physician on the day of enrollment	Device: Thermal Camera images acquisition - FeetSee; Thermal images will be collected according to the instructions for use of the Feetsee device.; Device: Thermal Camera images acquisition - Reference; After 15 minutes of resting, thermal images from the reference device will be collected according to their manufacturer
Active Comparator: Control; Generally Healthy Non-diabetic Subjects	Device: Thermal Camera images acquisition - FeetSee; Thermal images will be collected according to the instructions for use of the Feetsee device.; Device: Thermal Camera images acquisition - Reference; After 15 minutes of resting, thermal images from the reference device will be collected according to their manufacturer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimate of a difference in temperature between two feet per subject	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.	through study completion, on average within of 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Diabetis JSC

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2021
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: November 25, 2021
• First Submitted That Met QC Criteria: January 22, 2022
• First Posted (Actual): February 3, 2022

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 12, 2024
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Ulcer; Diabetic Foot
• Other Study ID Numbers: RD-FS-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No