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

Not Applicable

Recruiting

• Conditions: Diabetic Foot Ulcer
• Interventions: Device: Podimetrics SmartMat

• Registration Number: NCT05968924
• Lead Sponsor: Montefiore Medical Center

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) and have case report form filled out.

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 Timeline

• Study First Submitted: 2023-07-20
• Study First Submitted QC: 2023-07-28
• Study First Posted: 2023-08-01
• Study Start: 2024-07-03
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Type 1 or Type 2 diabetes mellitus
2. Prior treatment of DFU within 24 months
3. Subject had at least one outpatient follow up with a provider after treatment for DFU
4. No active ulcer at time of enrollment
5. Male or female, aged 18-75 yrs
6. Presence of Neuropathy
7. Ambulatory
8. Provision of signed and dated informed consent form
9. Stated willingness to adhere with all study procedures and availability to participate for the duration of the study

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
High risk Diabetic Foot Ulcer (DFU)	Podimetrics SmartMat	Podimetrics smart map

Primary Outcome Measures

Name	Time	Method
Adherence to use of SmartMat	Six months	Participant adherence to use of SmartMat will be quantified by automated data collection. % of daily use over 6 months will be summarized and reported.

Secondary Outcome Measures

Name	Time	Method
Occurrence of Diabetic Foot Ulcer (DFU)	Up to six months	The number of participants who develop DFU during the course of the study will be summarized and reported.
Use of health care facilities	Up to six months	Enumerate total number of health care visits over the course of the study. This will include patient visits to the Emergency Room (ER), podiatrist, internist, walk in clinic, and other health care facilities and will be be based on subject self-reporting of visits.

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States