N/A
N=20
Improving DFU Outcomes: Early Detection of Foot Ulcers Using Novel Technology
Diabetic Foot Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT05968924 ↗Enrolled (actual)
20
Serious AEs
30.0%
Results posted
Apr 2026
Primary outcome: Primary: Adherence to Use of SmartMat — 6.4 number of foot scans/week
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Podimetrics SmartMat (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Apr 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adherence to Use of SmartMat |
6.4 | — |
| SECONDARY Use of Health Care Facilities |
6 | — |
| SECONDARY Occurrence of Diabetic Foot Ulcer (DFU) |
5 | — |
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 temperature that may predict foot ulceration in patients with diabetes mellitus. This mat, the Podimetrics Smart Mat, is FDA cleared.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- Active diabetic foot ulcer (DFU)
- Unable to comply with study requirements
- Prior above-knee amputation (AKA) or below-knee amputation (BKA)
Data sourced from ClinicalTrials.gov (NCT05968924). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.