Improving DFU Outcomes: Early Detection of Foot Ulcers Using Novel Technology
- Conditions
- Diabetic Foot Ulcer
- Registration Number
- NCT05968924
- Lead Sponsor
- Montefiore Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria:<br><br> 1. Type 1 or Type 2 diabetes mellitus<br><br> 2. Prior treatment of DFU within 24 months<br><br> 3. Subject had at least one outpatient follow up with a provider after treatment for<br> DFU<br><br> 4. No active ulcer at time of enrollment<br><br> 5. Male or female, aged 18-75 yrs<br><br> 6. Presence of Neuropathy<br><br> 7. Ambulatory<br><br> 8. Provision of signed and dated informed consent form<br><br> 9. Stated willingness to adhere with all study procedures and availability to<br> participate for the duration of the study<br><br>Exclusion Criteria:<br><br> 1. Active diabetic foot ulcer (DFU)<br><br> 2. Unable to comply with study requirements<br><br> 3. Prior above-knee amputation (AKA) or below-knee amputation (BKA)
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adherence to use of SmartMat
- Secondary Outcome Measures
Name Time Method Use of health care facilities;Occurrence of Diabetic Foot Ulcer (DFU)