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

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ClinicalTrials.gov Identifier: NCT05968924
Recruitment Status : Not yet recruiting
First Posted : August 1, 2023
Last Update Posted : April 3, 2024
Sponsor:
Collaborator:
Podimetrics, Inc.
Information provided by (Responsible Party):
Montefiore Medical Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Device: Podimetrics SmartMat Not Applicable

Detailed Description:

Innovations toward the prevention of diabetic foot ulcer (DFU) are needed. Early detection of changes in the foot that predict the development of DFU could allow timely intervention to prevent the limb damage that occurs with advanced DFU.

Studies have demonstrated that increased temperature in the foot presage the development of DFU. Temperature changes can accurately be detected by home monitoring devices and predict impending ulceration. Here the study team will test the uptake of novel foot temperature monitoring technology for a future intervention study to determine if a home monitoring device could prevent the occurrence of severe DFU for patients at Montefiore Medical Center (MMC).

The investigator team will conduct a longitudinal study to determine the adherence to an FDA cleared device, Podimetrics, which has been tested in other populations and shown to 1) decrease the risk of severe DFU, and 2) decrease the utilization of health care resources in high risk patients with a history of DFU.

For this study, the study team will identify and enroll patients who are at high risk for DFU. These participants will be identified from the electronic medical record (EMR).

After providing informed consent, study participants will receive the foot mat and obtain training remotely from Podimetrics, which provides a standardized training program.

Participants briefly stand on the mat daily (20 seconds), and the temperature data is automatically sent for analysis to Podimetrics to interpret the information. The participants will be evaluated over a six-month period to measure:

  1. daily use of the technology
  2. Secondary outcomes: occurrence of DFU and use of health care resources.

Study participants will be contacted every month by the Einstein investigators to assess foot health. Study participants will be instructed to contact the study team during the study period to inquire if development of any changes in the foot such as the diagnosis of DFU, or if a foot cast is required for offloading, or if participants have any concerns about their feet.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Improving DFU Outcomes: Early Detection of Foot Ulcers Using Novel Technology
Estimated Study Start Date : May 2024
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: High risk Diabetic Foot Ulcer (DFU)
Podimetrics smart map
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Adherence to use of SmartMat [ Time Frame: Six months ]
    Enumerate daily use of stepping on SmartMat (automated data collection) (% of daily use over 6 months)


Secondary Outcome Measures :
  1. Use of health care facilities [ Time Frame: Six months ]
    Enumerate total number of health care visits (ER, podiatrist, internist, walk in clinic, etc.) (number of visits over total study time) (subject self report)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05968924


Contacts
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Contact: Johanna Daily, MD 718-678-1176 jdaily@montefiore.org

Locations
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United States, New York
Montefiore.Medical Center
Bronx, New York, United States, 10461
Contact: Johanna P Daily, MD    617-680-5112    johanna.daily@einsteinmed.edu   
Contact: Alyson Myers, MD    866-633-8255      
Sponsors and Collaborators
Montefiore Medical Center
Podimetrics, Inc.
Investigators
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Principal Investigator: Johanna Daily, MD Montefiore Medical Center
More Information
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Responsible Party: Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT05968924    
Other Study ID Numbers: 2023-14915
First Posted: August 1, 2023    Key Record Dates
Last Update Posted: April 3, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Montefiore Medical Center:
Diabetes
Foot Ulcer
Prevention
Innovation
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
 Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases