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

RECRUITING

I'm interested ...!!

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

🗓️ Study Start (Actual) July 2024

🗓️ Primary Completion (Estimated) May 2025

✅ Study Completion (Estimated) May 2025

👥 Enrollment (Estimated) 25

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 Bronx, New York, United States

📋 Eligibility Criteria

Description

Inclusion Criteria:

1. Type 1 or Type 2 diabetes mellitus
2. Prior history of a DFU within 12 months
3. Subject had at least one outpatient follow up with a provider after diagnosis with DFU
4. No active ulcer at time of enrollment
5. Male or female, aged \<18-75 yrs\>
6. Ambulatory
7. Provision of signed and dated informed consent form
8. Stated willingness to comply with all study procedures and availability for the duration of the study
9. Amputation (not TMA or AKA/BKA) allowed (transmetatarsal, amputation, or above or below knee)

Exclusion Criteria:

1. Active diabetic foot ulcer (DFU)
2. Unable to comply with study requirements
3. Prior TMA or AKA/BKA (transmetatarsal, amputation, or above or below knee) amputation

Ages Eligible for Study: 18 Years to 75 Years (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 20 July 2023
First Submitted that Met QC Criteria 28 July 2023
First Posted 1 August 2023

Study Record Updates

Last Update Submitted that Met QC Criteria 27 June 2024
Last Update Posted 28 June 2024
Last Verified June 2024