Status:
COMPLETED
Improving DFU Outcomes: Early Detection of Foot Ulcers Using Novel Technology
Lead Sponsor:
Montefiore Medical Center
Collaborating Sponsors:
Podimetrics, Inc.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The investigator team will study the adherence of the participant cohort to a non significant risk device over a six month period. The device is a foot mat, which can detect changes in foot temperatur...
Detailed Description
Innovations toward the prevention of diabetic foot ulcer (DFU) are needed. Early detection of changes in the foot that predict the development of DFU could allow timely intervention to prevent the lim...
Eligibility Criteria
Inclusion
- Type 1 or Type 2 diabetes mellitus
- Prior treatment of DFU within 24 months
- Subject had at least one outpatient follow up with a provider after treatment for DFU
- No active ulcer at time of enrollment
- Male or female, aged 18-75 yrs
- Presence of Neuropathy
- Ambulatory
- Provision of signed and dated informed consent form
- Stated willingness to adhere with all study procedures and availability to participate for the duration of the study
Exclusion
- Active diabetic foot ulcer (DFU)
- Unable to comply with study requirements
- Prior above-knee amputation (AKA) or below-knee amputation (BKA)
Key Trial Info
Start Date :
July 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05968924
Start Date
July 3 2024
End Date
April 3 2025
Last Update
September 25 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Montefiore Medical Center
The Bronx, New York, United States, 10461