COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-07-03
Study Completion:2025-04-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05968924

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.

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

Contacts and Locations

Principal Investigator

Johanna Daily, MD
PRINCIPAL_INVESTIGATOR
Montefiore Medical Center

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Montefiore Medical Center

  • Johanna Daily, MD, PRINCIPAL_INVESTIGATOR, Montefiore Medical Center

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

Study Start Date2024-07-03
Study Completion Date2025-04-03

Study Record Updates

Study Start Date2024-07-03
Study Completion Date2025-04-03

Terms related to this study

Keywords Provided by Researchers

  • Diabetes
  • Foot Ulcer
  • Prevention
  • Innovation

Additional Relevant MeSH Terms

  • Diabetic Foot Ulcer