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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetic with Ulcers | Experimental | Patient with diabetic foot and ulceration diagnosed/confirmed by the study physician on the day of enrollment |
|
| Diabetic without Ulcers | Experimental | Patient without ulcers diagnosed/confirmed by the study physician on the day of enrollment |
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| Control | Active Comparator | Generally Healthy Non-diabetic Subjects |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermal Camera images acquisition - FeetSee | Device | Thermal images will be collected according to the instructions for use of the Feetsee device. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Inclusion Criteria
Group 1/2: Diabetic with/without ulcers
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inlita Santara CTC | Vilnius | Lithuania |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| Thermal Camera images acquisition - Reference | Device | After 15 minutes of resting, thermal images from the reference device will be collected according to their manufacturer |
|
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |