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

项目摘要/摘要 意义：有一个明显未得到满足的需求，即减少300多万人的治疗时间和成本 仅在美国，腿部慢性伤口的患者就消耗了每年医疗支出的3%。标准护理 是通过换药来管理伤口的水分，通过多层压缩包扎来管理伤口的肿胀 糖尿病创面的静脉创面和通过可拆卸管型步行器卸载，并每日给药。 两种类型的患者的部分行走和抬高。伤口敷料一次换一次或两次 根据伤口护理中心的专家或3-6岁的家庭来访护士的猜测而确定的一周 需要几个月(或更长)才能痊愈。虽然标准护理已经被证明可以有效地治愈 慢性腿部创伤，不幸的是，在超过50%的就诊中，伤口敷料更换得太早或太早 太晚了，导致失去了治愈的日子。压缩包裹物失去治疗压力或可拆卸石膏步行器 患者经常不能每天行走超过10分钟，也不能抬起他们受伤的腿 而久坐导致愈合的进一步延迟。创新：SuraMedical拟议的第一阶段研究 旨在展示我们创新的原型WoundAlert治疗监测系统的临床疗效 减少治愈慢性腿部伤口的时间。WoundAlert支持实时监控和优化 关键标准护理治疗参数，如敷料水分和包扎压力以及患者 通过行走和腿部抬高跟踪实现参与度和遵从性。这是通过一个 无线可穿戴传感器标签与用于存储患者数据和参与度的移动应用程序配对，并由 临床医生云仪表板界面。初步数据：到目前为止的研究涉及到 原型硬件和软件，实验室和人类主体性能测试，以及探索 与潜在合作伙伴和投资者的商业机会。面向健康人群的原型系统研究 志愿人员已导致在拟议工作的目标1中进行系统改进，以准备 目标2.具体目标：开发最低限度可行的临床原型是 目的1基于初步数据和测试。Milestones是一个拥有6个月电池的临床原型系统 生命和可制造设计，价值20美元，10000个数量，通过10个伤口的焦点小组测试进行验证 照顾者。目的2重点展示WoundAlert系统在提高 通过实时监测15例患者的临床研究，小腿静脉创面的愈合率 干预组与15名患者对照组比较。成功的衡量标准将在统计上具有重要意义 (P&lt；0.05)伤口愈合率提高10%以上。第二阶段的后续工作将于 FDA提出的第一阶段工作说明的改进并导致了最终的疗效研究 提交许可和可能影响患者预后的商业产品，以及 全系统的医疗保健成本。

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.