CompletedNot Applicable

Improving DFU Outcomes: Early Detection of Foot Ulcers Using Novel Technology

United States20 participantsStarted 2024-07-03

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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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

Exclusion criteria

✕. Active diabetic foot ulcer (DFU)
✕. Unable to comply with study requirements
✕. Prior above-knee amputation (AKA) or below-knee amputation (BKA)

What they're measuring

Adherence to Use of SmartMat

Timeframe: Up to six months following intervention

Trial details

NCT IDNCT05968924

SponsorMontefiore Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-03

Results submitted2026-04-03

View on ClinicalTrials.gov More Diabetic Foot Ulcer trials