Reducing time to heal chronic leg wounds through monitoring, engagement and intelligent intervention via WoundAlert system

通过 WoundAlert 系统进行监控、参与和智能干预，减少慢性腿部伤口的愈合时间

• 批准号: 10325512
• 负责人: Jonathan M Engel
• 金额: $ 30万
• 依托单位: SURAMEDICAL, LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-05 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10325512
• 关键词: Address; Adverse reactions; Aging; Appointment; Area; Automobile Driving; Back; Behavioral; Caregivers; Chronic; Clinical; Clinical Research; Compression Bandage; Computer software; Counseling; Data; Databases; Development; Diabetic Foot Ulcer; Enrollment; Exhibits; Feedback; Focus Groups; Goals; Health; Health Care Costs; Health Expenditures; Health Professional; Healthcare; Healthcare Systems; Home; Intelligence; Intervention; Lead; Learning; Leg; Life; Life Style; Medicine; Metric System; Monitor; Nurses; Pain; Patient Monitoring; Patient-Focused Outcomes; Patients; Persons; Phase; Physicians; Positioning Attribute; Preparation; Provider; Quality of life; Recommendation; Research; Safety; Side; Specialist; Sterile coverings; Surveys; Swelling; System; Technology; Telephone; Testing; Therapeutic; Time; Time Study; Training; Treatment Protocols; Venous; Visit; Visiting Nurse; Walkers; Walking; Wireless Technology; Work; arm; base; bone; care providers; chronic wound; clinical efficacy; clinically significant; cohort; compliance behavior; cost; cost outcomes; dashboard; decubitus ulcer; design; diabetic ulcer; efficacy clinical trial; efficacy study; efficacy trial; experience; follow-up; healing; healthy volunteer; human subject; improved; innovation; manufacturability; mobile application; older patient; patient engagement; pedometer; performance tests; phase II trial; premature; pressure; prevent; product development; prototype; provider intervention; real time monitoring; remote monitoring; sedentary; sensor; smartphone Application; social engagement; standard care; success; treatment arm; trend; usability; wearable sensor technology; wound; wound care; wound dressing; wound healing; wound treatment

Project Summary/ Abstract Significance: There is a clear unmet need to reduce the treatment time and cost of the more than 3 million patients with chronic leg wounds draining 3% of annual healthcare expenditure in the US alone. Standard care is to manage wound moisture through dressing changes, swelling through multilayer compression wraps for venous wounds and offloading via removable cast walker for diabetic wounds, and to prescribe daily ambulation and elevation on the part of both types of patient. Wound dressings are changed once or twice a week based on guesswork by specialists at a wound care center or in the home by a visiting nurse for the 3-6 months (or longer) that is required to heal. While standard care has been demonstrated to effectively heal chronic leg wounds, unfortunately in more than 50% of visits, wound dressings are changed too early or too late, leading to lost healing days. Compression wraps lose therapeutic pressure or removable cast walkers are not worn and patients often fail to ambulate more than 10 minutes per day or to elevate their wounded leg while sedentary leading to further delays in healing. Innovation: SuraMedical’s proposed Phase I research seeks to demonstrate the clinical efficacy of our innovative prototype WoundAlert treatment monitoring system in reducing the time to heal chronic leg wounds. WoundAlert enables real-time monitoring and optimization of critical standard care treatment parameters such as dressing moisture and wrap pressure as well as patient engagement and compliance through ambulation and leg elevation tracking. This is accomplished via a wireless wearable sensor tag paired to a mobile app for patient data and engagement and overseen by a clinician cloud dashboard interface. Preliminary Data: Research to date has involved development of prototype hardware and software, lab and human subject performance testing, as well as exploring the commercial opportunity with potential partners and investors. Study of the prototype system with healthy volunteers has led to system improvements to be undertaken in Aim 1 of the proposed work in preparation for clinical study in Aim 2. Specific Aims: Development of a minimum viable clinical prototype is the goal of Aim 1 based on preliminary data and testing. Milestones are a clinical prototype system with 6-month battery life and manufacturable design with <$20 cost at >10k quantity, validated by focus group testing with 10 wound care providers. Aim 2 focuses on demonstrating WoundAlert system clinical efficacy in increasing the rate of healing in venous leg wounds through a clinical study with real time monitoring of a 15 patient intervention arm compared to a 15 patient control arm. The metric for success will be a statistically significant (p<0.05) increase of greater than 10% in wound healing rate. Follow up work in Phase II will close the loop on improvements illuminated by the proposed Phase I work and lead to definitive efficacy studies, FDA submission for clearance and a commercial product with the potential to impact patient outcomes and system-wide healthcare costs.

项目摘要/摘要 意义：明显的未满足需要减少超过300万的治疗时间和成本 仅在美国，慢性腿部伤口的患者就会耗尽3％的年度医疗支出。标准护理 是通过更换穿衣来管理风湿，通过多层压缩膜膨胀 静脉风和通过可移动的铸造助行器进行糖尿病风，并每天准备 两种类型的患者部分的行动和抬高。伤口敷料一次或两次 一周根据胜利护理中心的专家的猜测，或者是在家中的3-6的访客护士 几个月（或更长的时间）才能治愈。虽然已证明标准护理有效地治愈 慢性腿获胜，不幸的是，在50％以上的访问中，赢得敷料的变化太早或也是如此 迟到，导致失去治愈的日子。压缩包裹会失去治疗压力或可移动的步行者 不磨损，患者通常每天无法行动超过10分钟或抬高受伤的腿 而久坐的导致进一步延迟了康复。创新：Suramedical提议的第一阶段研究 试图证明我们创新的原型伤口治疗监测系统的临床效率 减少治愈慢性腿伤的时间。伤口剂实现实时监控和优化 关键标准护理治疗参数，例如敷料水分和包裹压力以及患者 通过救护车和腿部抬高跟踪的参与和合规性。这是通过 无线可穿戴传感器标签与移动应用程序配对，以用于患者数据，参与度以及海外 临床云仪表板接口。初步数据：迄今为止的研究涉及开发 原型硬件和软件，实验室和人类主题绩效测试以及探索 与潜在合作伙伴和投资者的商业机会。健康的原型系统 志愿者已导致在拟议工作的目标1中进行系统的改进，以准备 AIM 2中的临床研究。具体目的：开发最低可行临床原型的目的是 基于初步数据和测试的目标1。里程碑是带有6个月电池的临床原型系统 寿命和制造的设计，<20美元的成本> 10K数量，通过焦点小组测试，有10个伤口验证 护理提供者。 AIM 2专注于展示伤口系统的临床效率 通过临床研究，对15例患者进行实时监测，静脉腿伤口的愈合率 干预臂与15个患者对照组相比。成功的指标将是一个统计学意义的 （p <0.05）增加了伤口愈合率大于10％。第二阶段的后续工作将关闭循环 提议的I期工作阐明了改进，并导致确定的效率研究，FDA 提交清算和商业产品，有可能影响患者的结果和 全系统的医疗保健费用。