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

Sponsor

Montefiore Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05968924

Collaborator

Podimetrics, Inc. (Industry)

Enrollment

Location

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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 PodimetricsSmart Mat, is FDA cleared.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Foot Ulcer	Device: PodimetricsSmart Mat

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:

daily use of the technology
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

Study Type:

Observational

Anticipated Enrollment :

25 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
High risk DFU Type 1 or Type 2 diabetes mellitus Prior history of a healed DFU within 12 months Subject had at least one outpatient follow up with a provider after diagnosis with a DFU No active ulcer at the time of enrollment Male or female, aged <18-75 yrs> Ambulatory Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Amputation (not TMA or BKA) allowed	Device: PodimetricsSmart Mat receive training on stepping on SmartMat each day for 6 months; and step on the mat every day for 6 months; monthly phone calls will be conducted to assess foot health and mat.

Arm

Intervention/Treatment

High risk DFU

Type 1 or Type 2 diabetes mellitus Prior history of a healed DFU within 12 months Subject had at least one outpatient follow up with a provider after diagnosis with a DFU No active ulcer at the time of enrollment Male or female, aged <18-75 yrs> Ambulatory Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Amputation (not TMA or BKA) allowed

Device: PodimetricsSmart Mat

receive training on stepping on SmartMat each day for 6 months; and step on the mat every day for 6 months; monthly phone calls will be conducted to assess foot health and mat.

Outcome Measures

Primary Outcome Measures

Adherence to use of SmartMat [Six months]
Enumerate daily use of stepping on SmartMat (automated data collection) (% of daily use over 6 months)

Secondary Outcome Measures

Use of health care facilities [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

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Type 1 or Type 2 diabetes mellitus
Prior history of a DFU within 12 months
Subject had at least one outpatient follow up with a provider after diagnosis with DFU
No active ulcer at time of enrollment
Male or female, aged <18-75 yrs>
Ambulatory
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Amputation (not TMA or AKA/BKA) allowed (transmetatarsal, amputation, or above or below knee)

Exclusion Criteria:

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)