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

Part of paid clinical trials in The Bronx, New York.

Sponsor
Montefiore Medical Center
Study ID
NCT05968924
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Podimetrics SmartMat — DEVICE
    Participants receive training for stepping on SmartMat each day for 6 months. Monthly phone calls will be conducted to assess foot health and mat.

Study Details

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.

Key Dates

Start date
Jul 3, 2024
Status verified
Apr 2026
Primary completion
Apr 3, 2025
Completion
Apr 3, 2025

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Experimental: High risk Diabetic Foot Ulcer (DFU)
    Podimetrics smart map

Primary Outcome Measure

Adherence to Use of SmartMat [ Time Frame: Up to six months following intervention ]

Locations (1)

FacilityCityStateZIPSite coordinators
Montefiore Medical CenterThe BronxNew York10461-

Find similar trials in The Bronx, NY

By research site
Montefiore Medical Center· The Bronx, NY

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