Improving DFU Outcomes: Early Detection of Foot Ulcers Using Novel Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Adherence to Use of SmartMat
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Active diabetic foot ulcer (DFU)
- •Unable to comply with study requirements
- •Prior above-knee amputation (AKA) or below-knee amputation (BKA)
研究组 & 干预措施
High risk Diabetic Foot Ulcer (DFU)
Podimetrics smart map
干预措施: Podimetrics SmartMat (Device)
结局指标
主要结局
Adherence to Use of SmartMat
时间窗: Up to six months following intervention
Participant adherence to use of SmartMat will be quantified by automated data collection. Adherence is defined as having conducted \>3 days foot scans per week (foot scans/week) over the six-month period. The median number of scans/week over a six-month period is reported.
次要结局
- Use of Health Care Facilities(Up to six months following intervention)
- Occurrence of Diabetic Foot Ulcer (DFU)(Up to six months following intervention)
