Status:
COMPLETED
FeetSee Thermal Images Collection Protocol
Lead Sponsor:
Diabetis JSC
Conditions:
Diabetic Foot
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 so...
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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Group 1/2: Diabetic with/without ulcers
- Male/Female, 18 years or older
- Diagnosis of type 1 or type 2 Diabetes Mellitus, confirmed by a family physician or an endocrinologist.
- Patient with or without history of previous foot ulcer, confirmed by a family physician or an endocrinologist
- 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
- 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
- Critical ischemia and/or deep ulceration (grades 4 or 5 according to Texas grading system).
- Active Infection/Gangrene
- Active malignancy
- Immunosuppressive disease
- History of alcohol or drug abuse
- Pregnant women (verbal confirmation or confirmation obtained within current medical records)
- Cognitive deficit
- End-stage renal disease
- History of amputation proximal to the Trans-metatarsal (TM) joint
- Other issues that, at the discretion of the investigator, renders the subject ineligible for participation.
Key Trial Info
Start Date :
July 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT05222490
Start Date
July 13 2021
End Date
February 28 2022
Last Update
August 13 2024
Active Locations (1)
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1
Inlita Santara CTC
Vilnius, Lithuania