FeetSee Thermal Images Collection Protocol

Diabetic Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05222490
• Other study ID #: RD-FS-01
• Status: Recruiting
• Phase: N/A
• Start date: July 13, 2021
• Est. completion date: February 2022

Study information

• Verified date: November 2021
• Source: Diabetis JSC
• Contact: Helena Grinberg, PhD
• Phone: +31615636666
• Email: lenagrin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: February 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot

Intervention

Device:
• Thermal Camera images acquisition - FeetSee
Thermal images will be collected according to the instructions for use of the Feetsee device.
• Thermal Camera images acquisition - Reference
After 15 minutes of resting, thermal images from the reference device will be collected according to their manufacturer

Locations

Country	Name	City	State
Lithuania	Inlita Santara CTC	Vilnius

Sponsors (1)

Lead Sponsor	Collaborator
Diabetis JSC

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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