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

Diabetic Foot Ulcer Clinical Trial

— DFUMAT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05968924
• Other study ID #: 2023-14915
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Montefiore Medical Center
• Contact: Johanna Daily, MD
• Phone: 718-678-1176
• Email: jdaily[@]montefiore.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• 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.

Locations

Country	Name	City	State
United States	Montefiore.Medical Center	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Montefiore Medical Center	Podimetrics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to use of SmartMat	Enumerate daily use of stepping on SmartMat (automated data collection) (% of daily use over 6 months)	Six months
Secondary	Use of health care facilities	Enumerate total number of health care visits (ER, podiatrist, internist, walk in clinic, etc.) (number of visits over total study time) (subject self report)	Six months