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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Diabetic Foot Ulcer
Intervention / Treatment

-

Contacts and Locations

Bronx

Montefiore Medical Center, Bronx, New York, United States, 10461

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Type 1 or Type 2 diabetes mellitus
  • 2. Prior treatment of DFU within 24 months
  • 3. Subject had at least one outpatient follow up with a provider after treatment for DFU
  • 4. No active ulcer at time of enrollment
  • 5. Male or female, aged 18-75 yrs
  • 6. Presence of Neuropathy
  • 7. Ambulatory
  • 8. Provision of signed and dated informed consent form
  • 9. Stated willingness to adhere with all study procedures and availability to participate for the duration of the study
  • 1. Active diabetic foot ulcer (DFU)
  • 2. Unable to comply with study requirements
  • 3. Prior above-knee amputation (AKA) or below-knee amputation (BKA)

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Montefiore Medical Center,

Johanna Daily, MD, PRINCIPAL_INVESTIGATOR, Montefiore Medical Center

Study Record Dates

2025-05