FeetSee Thermal Images Collection Protocol

NCT05222490 | Completed

• 1 other identifier: RD-FS-01
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• To evaluate the usability of FeeSee device by patient and healthcare providers

  through study completion, an average of 1 year

Study Arms (3)

Diabetic with Ulcers

EXPERIMENTAL

Patient with diabetic foot and ulceration diagnosed/confirmed by the study physician on the day of enrollment

Device: Thermal Camera images acquisition - FeetSee; Device: Thermal Camera images acquisition - Reference

Diabetic without Ulcers

EXPERIMENTAL

Patient without ulcers diagnosed/confirmed by the study physician on the day of enrollment

Device: Thermal Camera images acquisition - FeetSee; Device: Thermal Camera images acquisition - Reference

Control

ACTIVE COMPARATOR

Generally Healthy Non-diabetic Subjects

Device: Thermal Camera images acquisition - FeetSee; Device: Thermal Camera images acquisition - Reference

Interventions

Thermal Camera images acquisition - FeetSee DEVICE

Thermal images will be collected according to the instructions for use of the Feetsee device.

Control; Diabetic with Ulcers; Diabetic without Ulcers

Thermal Camera images acquisition - Reference DEVICE

After 15 minutes of resting, thermal images from the reference device will be collected according to their manufacturer

Control; Diabetic with Ulcers; Diabetic without Ulcers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \. 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Diabetis JSC: lead

Study Sites (1)

Inlita Santara CTC

Vilnius, Lithuania

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: February 3, 2022
• Study Start: July 13, 2021
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: August 13, 2024

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)