Toward smart personalized electrotherapy for enhanced healing of ischemic wounds

走向智能个性化电疗以促进缺血性伤口的愈合

• 批准号: 10371014
• 负责人: KATH BOGIE
• 金额: --
• 依托单位: LOUIS STOKES CLEVELAND VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-03-01 至 2022-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10371014
• 关键词: 3-Dimensional; Acute; Animal Model; Animals; Bacterial Infections; Bandage; Biomedical Technology; Blood gas; Caring; Chronic; Clinic; Clinical; Clinical Practice Guideline; Collaborations; Communication; Computer software; Curettage procedure; Custom; Data; Development; Devices; Digital Photography; Electric Stimulation; Electric Stimulation Therapy; Electronics; Ensure; Face; Family suidae; Feedback; Foundations; Frequencies; Genes; Granulation Tissue; Healthcare; Histology; Immunohistochemistry; Impairment; Infection; Instruction; International; Intervention; Ischemia; Legal patent; Life; Liquid substance; Long-Term Care; Methodology; Microbial Biofilms; Modification; Monitor; Outcome; Pain; Patients; Power Sources; Pre-Clinical Model; Process; Protocols documentation; Rattus; Recommendation; Recording of previous events; Risk; Running; Secure; Sterile coverings; Surface; Swab; System; Systems Development; Technology; Temperature; Testing; Time; Tissues; Translations; Update; Veterans; Wireless Technology; Work; Wound Infection; Wound models; base; biomaterial compatibility; chronic wound; clinical care; clinically relevant; cost; cost outcomes; decubitus ulcer; design; disability; effective therapy; electric impedance; encryption; flexibility; healing; high standard; improved; improved outcome; in vivo; innovation; microbial community; military veteran; multidisciplinary; novel strategies; patient safety; personalized care; personalized therapeutic; porcine model; pre-clinical; preclinical development; preclinical evaluation; pressure; programs; prototype; real time monitoring; remote monitoring; research clinical testing; safety testing; software development; theranostics; trend; user-friendly; wireless communication; wound; wound bed; wound care; wound dressing; wound healing; wound treatment

Non-healing ischemic wounds are a major problem for Veterans with physical impairment and/or disability. These chronic wounds cause significant pain and disability and occur at an alarmingly high frequency in at-risk Veteran populations cared for by the Veterans Healthcare Administration (VHA). The use of electrical stimulation (ES) for ischemic wound therapy has long been known but the outcomes have been variable. In previous work we developed an untethered electronic bandage with all the components of a surface stimulation system mounted on a flexible substrate. We systematically investigated the effects of a range of clinically relevant ES and found two paradigms that significantly enhanced healing in a rat ischemic wound model. One of these paradigms was also found to significantly reduce wound infection in an acute preclinical model of clinically relevant large wounds. The project will provide translational development and testing in a relevant large animal model of the Smart Modular Adaptive Electrotherapy Delivery System (SmartMAEDS) to provide both treatment and remote monitoring of chronic ischemic wounds. The patented SmartMAEDS system is an innovative approach incorporating both ES and real-time wound monitoring. SmartMAEDS will reduce cost and improve healing efficacy by providing therapeutic ES in a bandage that does not need to be repositioned for each treatment session thus improving uniformity of ES therapy. SmartMAEDS also provides innovative remote monitoring capabilities to reduce unnecessary dressing changes. By assessing wound bed impedance, SmartMAEDS will monitor progress towards healing. SmartMAEDS will also check for early indications of infection by monitoring wound bed temperature. Development of the Smart MAEDS system will include refinement of the disposable flexible substrate and the reusable stimulation/control module. Our collaborators at Koronis Biomedical Technologies will develop two software applications to manage SmartMAEDS wireless communication. StimCheck will run in the background providing instant feedback on connection status. StimMANAGE will provide a clinical user interface for real time monitoring of wound status including graphical history and trends, enabling the clinician to control and modify therapy as needed. We will evaluate SmartMAEDS in a pig model of ischemic wounds of a clinically relevant size. ES paradigms shown to enhance healing and reduce infection in our preliminary work will be assessed. Quantitative non-destructive in vivo assessment methodologies will include monitoring of tissue ischemia and progressive wound healing using transcutaneous blood gas levels and serial 3D digital photography. Wound status at fixed timepoints will be evaluated using histology, histomorphometry, immunohistochemistry and rt-PCR to determine the expression of over 80 genes involved in all stages of wound healing. Planktonic bacterial infection status, biofilm formation and microbial community profiling will also be evaluated following protocols developed in our previous work. Prototype SmartMAEDS devices have been developed under the Advanced Platform Technology Center Quality Systems/Design Control-program. A multidisciplinary clinical expert review panel will ensure that this new approach to chronic wound therapy will be highly acceptable to clinical users. The effective treatment of chronic wounds is integral to providing the highest standards of health care for Veterans. Translational pre- clinical evaluation of SmartMAEDS using a valid animal model will provide a strong foundation for effective translation to clinical care. Our collaboration with Koronis Biomedical Technologies will support pre-market development of a user-friendly bandage that can be worn for up to five days, concurrently delivering treatment and monitoring wound status. SmartMAEDS will be a disruptive value-driven technology in the wound care market at lower cost to VHA providing increased clinical benefit for Veterans with chronic wounds.

无法愈合的缺血性伤口是身体损伤和/或残疾的退伍军人面临的主要问题。 这些慢性伤口会导致严重的疼痛和残疾，并且在高危人群中发生的频率高得惊人。 由退伍军人医疗保健管理局 (VHA) 照顾的退伍军人群体。电气的使用 刺激（ES）用于缺血性伤口治疗早已为人所知，但结果却各不相同。在 在之前的工作中，我们开发了一种不受束缚的电子绷带，其中包含表面刺激的所有组件 系统安装在柔性基板上。我们系统地研究了一系列临床效果 相关的 ES 并发现了两种显着增强大鼠缺血性伤口模型愈合的范例。一 在急性临床前模型中，还发现这些范例可以显着减少伤口感染 临床相关的大伤口。 该项目将在 Smart 的相关大型动物模型中进行转化开发和测试 模块化自适应电疗传输系统 (SmartMAEDS) 可提供治疗和远程治疗 监测慢性缺血性伤口。获得专利的 SmartMAEDS 系统是一种创新方法 结合 ES 和实时伤口监测。 SmartMAEDS 将降低成本并改善愈合 通过在绷带中提供治疗性 ES 来提高疗效，无需每次治疗都重新定位 从而提高 ES 治疗的均匀性。 SmartMAEDS 还提供创新的远程监控 减少不必要的敷料更换的能力。通过评估伤口床阻抗，SmartMAEDS 将 监测愈合进展。 SmartMAEDS 还将通过监测来检查感染的早期迹象 伤口床温度。 Smart MAEDS 系统的开发将包括一次性柔性基材的改进和 可重复使用的刺激/控制模块。我们在 Koronis Biomedical Technologies 的合作者将开发两种 用于管理 SmartMAEDS 无线通信的软件应用程序。 StimCheck 将在后台运行 提供有关连接状态的即时反馈。 StimMANAGE 将提供真实的临床用户界面 时间监控伤口状态，包括图形历史和趋势，使临床医生能够控制和 根据需要修改治疗。我们将在临床猪缺血性伤口模型中评估 SmartMAEDS 相关尺寸。在我们的初步工作中，ES 范式被证明可以增强愈合并减少感染 评估。定量无损体内评估方法将包括组织监测 使用经皮血气水平和连续 3D 数字测量缺血和渐进性伤口愈合 摄影。将使用组织学、组织形态计量学、 免疫组织化学和 rt-PCR 测定涉及各个阶段的 80 多个基因的表达 伤口愈合。浮游细菌感染状态、生物膜形成和微生物群落分析将 也可以按照我们之前工作中制定的协议进行评估。 SmartMAEDS 原型设备已在先进平台技术中心下开发 质量体系/设计控制程序。多学科临床专家评审小组将确保这一点 慢性伤口治疗的新方法将被临床用户高度接受。有效治疗 慢性伤口是为退伍军人提供最高标准医疗保健不可或缺的一部分。翻译前 使用有效的动物模型对 SmartMAEDS 进行临床评估将为有效的 转化为临床护理。我们与 Koronis Biomedical Technologies 的合作将为上市前提供支持 开发出一种用户友好的绷带，可以佩戴长达五天，同时进行治疗 并监测伤口状态。 SmartMAEDS 将成为伤口护理领域的颠覆性价值驱动技术 以比 VHA 更低的成本进入市场，为患有慢性伤口的退伍军人提供更多的临床益处。