N/A
Completed N=20
Improving DFU Outcomes: Early Detection of Foot Ulcers Using Novel Technology
Source: ClinicalTrials.gov NCT05968924 ↗Enrolled (actual)
20
Serious AEs
30.0%
Results posted
Apr 2026
Primary outcomePrimary: Adherence to Use of SmartMat — 6.4 number of foot scans/week
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.
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 | — |
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. Informational only — not medical advice.