FeetSee Thermal Images Collection Protocol

Status Recruiting

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Diabetic Foot

Clinical Trial Details

NCT number	NCT05222490
Study type	Interventional
Source	Diabetis JSC
Contact	Helena Grinberg, PhD
Phone	+31615636666
Email	lenagrin@gmail.com
Status	Recruiting
Phase	N/A
Start date	July 13, 2021
Completion date	February 2022

View Details

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