Improving DFU Outcomes: Early Detection of Foot Ulcers Using Novel Technology
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Montefiore Medical Center
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Adherence to use of SmartMat
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Type 1 or Type 2 diabetes mellitus
- •Prior treatment of DFU within 24 months
- •Subject had at least one outpatient follow up with a provider after treatment for DFU
- •No active ulcer at time of enrollment
- •Male or female, aged 18-75 yrs
- •Presence of Neuropathy
- •Provision of signed and dated informed consent form
- •Stated willingness to adhere with all study procedures and availability to participate for the duration of the study
Exclusion Criteria
- •Active diabetic foot ulcer (DFU)
- •Unable to comply with study requirements
- •Prior above-knee amputation (AKA) or below-knee amputation (BKA)
Outcomes
Primary Outcomes
Adherence to use of SmartMat
Time Frame: 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 Outcomes
- Occurrence of Diabetic Foot Ulcer (DFU)(Up to six months)
- Use of health care facilities(Up to six months)