Back to resultsFeetSee Thermal Images Collection Protocol
Primary Purpose
Diabetic Foot
Status
Recruiting
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Thermal Camera images acquisition - FeetSee
Thermal Camera images acquisition - Reference
Sponsored by
About this trial
This is an interventional other trial for Diabetic Foot
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
- 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.
Sites / Locations
- Inlita Santara CTCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Diabetic with Ulcers
Diabetic without Ulcers
Control
Arm Description
Patient with diabetic foot and ulceration diagnosed/confirmed by the study physician on the day of enrollment
Patient without ulcers diagnosed/confirmed by the study physician on the day of enrollment
Generally Healthy Non-diabetic Subjects
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05222490
Brief Title
FeetSee Thermal Images Collection Protocol
Official Title
Collection of the Thermal Images of Diabetic Patients' Feet for FeetSee Device Performance Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2021 (Actual)
Primary Completion Date
February 2022 (Anticipated)
Study Completion Date
February 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Diabetis JSC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diabetic with Ulcers
Arm Type
Experimental
Arm Description
Patient with diabetic foot and ulceration diagnosed/confirmed by the study physician on the day of enrollment
Arm Title
Diabetic without Ulcers
Arm Type
Experimental
Arm Description
Patient without ulcers diagnosed/confirmed by the study physician on the day of enrollment
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Generally Healthy Non-diabetic Subjects
Intervention Type
Device
Intervention Name(s)
Thermal Camera images acquisition - FeetSee
Intervention Description
Thermal images will be collected according to the instructions for use of the Feetsee device.
Intervention Type
Device
Intervention Name(s)
Thermal Camera images acquisition - Reference
Intervention Description
After 15 minutes of resting, thermal images from the reference device will be collected according to their manufacturer
Primary Outcome Measure Information:
Title
Estimate of a difference in temperature between two feet per subject
Description
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.
Time Frame
through study completion, on average within of 1 year
Secondary Outcome Measure Information:
Title
To evaluate the usability of FeeSee device by patient and healthcare providers
Description
The evaluation of Feetsee device usability by patients or their healthcare providers using a a dedicated usability questioner.
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Helena Grinberg, PhD
Phone
+31615636666
Email
lenagrin@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Linas Liekis, M.D.
Phone
+37061225255
Email
linas.liekis@inlita.lt
Facility Information:
Facility Name
Inlita Santara CTC
City
Vilnius
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linas Leikis, MD
Phone
+37061225255
Email
linas.liekis@inlita.lt
First Name & Middle Initial & Last Name & Degree
Neringa Burokiene, M.D. PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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FeetSee Thermal Images Collection Protocol
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