Trials / Completed
CompletedNCT05222490
FeetSee Thermal Images Collection Protocol
Collection of the Thermal Images of Diabetic Patients' Feet for FeetSee Device Performance Evaluation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 112 (actual)
- Sponsor
- Diabetis JSC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2021-07-13
- Primary completion
- 2022-02-28
- Completion
- 2022-02-28
- First posted
- 2022-02-03
- Last updated
- 2024-08-13
Locations
1 site across 1 country: Lithuania
Source: ClinicalTrials.gov record NCT05222490. Inclusion in this directory is not an endorsement.