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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Device: PodimetricsSmart Mat


Participation Criteria
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Eligibility Criteria
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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: 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) -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High risk DFU<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to use of SmartMat | Enumerate daily use of stepping on SmartMat (automated data collection) (% of daily use over 6 months) | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Foot Ulcer, Prevention, Innovation