Feasibility of Remote Wound Care: Implementing a Patient-Centered Remote Wound Monitoring Solution Using a Smartphone Application
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Proportion of participants who successfully complete a weekly wound scan
研究概览
简要总结
The feasibility phase of the study was conducted to assess the feasibility of a novel, patient-centered, remote wound management system. The investigators will enroll 25 patients with an active diabetic foot ulcer (DFU) who present to the multidisciplinary diabetic foot clinic in Baltimore, Maryland.
The RCT is being done to compare two different methods of wound monitoring for chronic wounds: remote wound monitoring using a smartphone app and in-person wound monitoring in a clinic setting. This will be a pilot non-blinded randomized controlled feasibility trial. The investigators will enroll 120 patients with an active diabetic foot ulcer (DFU) who present to the multidisciplinary diabetic foot clinic in Baltimore, Maryland. Patients will be computer randomized 1:1 to receive wound care monitoring using remote DFU monitoring technology or standard in-person monitoring for 12 weeks.
详细描述
The purpose of this research is to determine if a smartphone mobile application, also referred to as a mobile app or simply an app, designed to capture wound measurements and analyze wound tissue distribution in real-time, can be a practical patient-centered solution for regular wound management and assessment. The app will be compared to traditional in-person wound monitoring. One of the major limitations of most literature describing remote monitoring technologies is the lack of a control group. By randomizing half of the enrolled patients in the RCT to remote monitoring via standard of care, the investigators will be able to compare patient and provider satisfaction with remote vs. in-person monitoring, as well as the wound healing outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged ≥ 18 years old
- •In treatment for lower extremity wound related to diabetic foot ulcer
- •Able and willing to use a smartphone to assess the wound for the duration of the study
- •English language proficiency
排除标准
- •Patients with less than 1 dressing change per week
- •Patients with wound size that cannot be covered with a single app scan (out of boundary conditions include wounds that wrap around patient's entire leg)
- •Patients with wounds in an inaccessible location who live without a caregiver to assist in taking wound scans
研究组 & 干预措施
Standard care
Patients randomized to receive standard of care will be provided with a wound care plan at the time of enrollment, and then follow-up in clinic on a biweekly basis (week 2, 4, 6, 8, 10, 12) for a wound check and care plan update as needed.
Remote wound monitoring technology
Enrolled patients (and their caregivers, if applicable) are given an in-person training on how to use the smartphone app to self-assess their wound during regular dressing changes. Wound assessments are electronically transmitted to a secure, dedicated portal up to once a week for remote review by the study doctors. In-person follow-up is monthly (at the time of enrollment, week 4, week 8, and week 12).
干预措施: Remote wound monitoring technology (Other)
结局指标
主要结局
Proportion of participants who successfully complete a weekly wound scan
时间窗: 12 weeks
Overall weekly scan rate
Part A Feasibility - Number of Participants With Wound Scan Completion
时间窗: 8 weeks
Participants were instructed on how to use the digital management system and were asked to perform one at-home wound scan per week for a total of 8 weeks.
Participants Who Successfully Complete Weekly Wound Scan
时间窗: 12 weeks
Successful weekly scan rate out of 12 weeks defined as total number of participants who successfully complete a weekly wound scan
次要结局
未报告次要终点