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

NCT05968924 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-04-30

Study results available
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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.

Conditions

  • Diabetic Foot Ulcer

Interventions

DEVICE

Podimetrics SmartMat

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

Sponsors & Collaborators

  • Podimetrics, Inc.

    collaborator INDUSTRY

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • American Diabetes Association

    collaborator OTHER

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Johanna Daily, MD · Montefiore Medical Center

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-03
Primary Completion
2025-04-03
Completion
2025-04-03
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05968924 on ClinicalTrials.gov