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

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

Tracking Information

• First Submitted Date: July 20, 2023
• First Posted Date: August 1, 2023
• Last Update Posted Date: April 3, 2024
• Estimated Study Start Date: May 2024
• Estimated Primary Completion Date: March 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 28, 2023)

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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 28, 2023)

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)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Improving DFU Outcomes: Early Detection of Foot Ulcers Using Novel Technology
• Official Title: Improving DFU Outcomes: Early Detection of Foot Ulcers Using Novel Technology
• 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.

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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Screening
• Condition: Diabetic Foot Ulcer

Intervention

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.

Study Arms

Experimental: High risk Diabetic Foot Ulcer (DFU)

Podimetrics smart map

Intervention: Device: Podimetrics SmartMat

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: July 28, 2023): 25
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2025
• Estimated Primary Completion Date: March 2025 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05968924
• Other Study ID Numbers: 2023-14915
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Montefiore Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Montefiore Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Podimetrics, Inc.

Investigators

• Principal Investigator: Johanna Daily, MD; Montefiore Medical Center

• PRS Account: Montefiore Medical Center
• Verification Date: April 2024