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FeetSee Thermal Images Collection Protocol

D

Diabetis JSC

Status

Completed

Conditions

Diabetic Foot

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT05222490
RD-FS-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

112 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Inclusion Criteria

Group 1/2: Diabetic with/without ulcers

  1. Male/Female, 18 years or older

  2. Diagnosis of type 1 or type 2 Diabetes Mellitus, confirmed by a family physician or an endocrinologist.

  3. Patient with or without history of previous foot ulcer, confirmed by a family physician or an endocrinologist

  4. 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

  5. Must be able to read, understand and sign the Informed Consent Form Control: Generally Healthy Non-diabetic

  6. 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

  1. Critical ischemia and/or deep ulceration (grades 4 or 5 according to Texas grading system).
  2. Active Infection/Gangrene
  3. Active malignancy
  4. Immunosuppressive disease
  5. History of alcohol or drug abuse
  6. Pregnant women (verbal confirmation or confirmation obtained within current medical records)
  7. Cognitive deficit
  8. End-stage renal disease
  9. History of amputation proximal to the Trans-metatarsal (TM) joint
  10. Other issues that, at the discretion of the investigator, renders the subject ineligible for participation.

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

112 participants in 3 patient groups

Diabetic with Ulcers
Experimental group
Description:
Patient with diabetic foot and ulceration diagnosed/confirmed by the study physician on the day of enrollment
Treatment:
Device: Thermal Camera images acquisition - Reference
Device: Thermal Camera images acquisition - FeetSee
Diabetic without Ulcers
Experimental group
Description:
Patient without ulcers diagnosed/confirmed by the study physician on the day of enrollment
Treatment:
Device: Thermal Camera images acquisition - Reference
Device: Thermal Camera images acquisition - FeetSee
Control
Active Comparator group
Description:
Generally Healthy Non-diabetic Subjects
Treatment:
Device: Thermal Camera images acquisition - Reference
Device: Thermal Camera images acquisition - FeetSee

Trial contacts and locations

1

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Central trial contact

Helena Grinberg, PhD; Linas Liekis, M.D.

Data sourced from clinicaltrials.gov

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