Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
112 participants
INTERVENTIONAL
2021-07-13
2022-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Use of Thermography for the Prevention and Diagnosis of Diabetic Foot
NCT06485362
Effectiveness of Remote Foot Temperature Monitoring
NCT05728411
Impact of Remote Foot Temperature Monitoring
NCT04345016
Thermographic Examination of Skin Temperatures in Individuals With Focal Onset Epilepsy
NCT01373190
Assessment of Safety Distance of Far-Infrared Therapeutic Device to Human Skin
NCT05191511
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Diabetic with Ulcers
Patient with diabetic foot and ulceration diagnosed/confirmed by the study physician on the day of enrollment
Thermal Camera images acquisition - FeetSee
Thermal images will be collected according to the instructions for use of the Feetsee device.
Thermal Camera images acquisition - Reference
After 15 minutes of resting, thermal images from the reference device will be collected according to their manufacturer
Diabetic without Ulcers
Patient without ulcers diagnosed/confirmed by the study physician on the day of enrollment
Thermal Camera images acquisition - FeetSee
Thermal images will be collected according to the instructions for use of the Feetsee device.
Thermal Camera images acquisition - Reference
After 15 minutes of resting, thermal images from the reference device will be collected according to their manufacturer
Control
Generally Healthy Non-diabetic Subjects
Thermal Camera images acquisition - FeetSee
Thermal images will be collected according to the instructions for use of the Feetsee device.
Thermal Camera images acquisition - Reference
After 15 minutes of resting, thermal images from the reference device will be collected according to their manufacturer
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Thermal Camera images acquisition - FeetSee
Thermal images will be collected according to the instructions for use of the Feetsee device.
Thermal Camera images acquisition - Reference
After 15 minutes of resting, thermal images from the reference device will be collected according to their manufacturer
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
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.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Diabetis JSC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Inlita Santara CTC
Vilnius, , Lithuania
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RD-FS-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.