Determination of physiological mechanisms for electrical wound therapy

描述(由申请人提供)： 无法正常愈合的伤口是许多身体受损和/或残疾的人的主要问题。这些慢性伤口会导致严重的疼痛和残疾，在高危患者群体中发生的频率高得令人震惊。电疗是使用电刺激(ES)治疗慢性创面的方法，人们很早就知道了，但效果并不可靠。这项拟议的研究将确定有效的电疗以提供缺血伤口完全愈合的生理机制，并使用临床前研究的结果来指导患有慢性不可愈合伤口的退伍军人的快速实施。一种无绳索电子绷带，将表面刺激系统的所有组件安装在柔性基板上，已为本研究定制使用。这种设备被称为模块化刺激系统(MSS)，将在整个研究中使用。一个多学科的研究团队将共同努力，以确保这种慢性伤口治疗的新方法将被临床用户高度接受。在用于临床前动物模型之前，设备将使用先进平台技术中心设计控制-质量系统计划定义的程序进行测试。MSS将用于大鼠缺血创伤模型，以评估提供最佳伤口愈合的电刺激变量和治疗持续时间。这将由几个标准定义，包括低炎症、血管生成增加、伤口快速闭合和正常瘢痕形成。对慢性伤口的有效治疗是为退伍军人提供最高标准的医疗保健不可或缺的一部分。使用有效的动物模型对用于慢性创面电疗的MSS进行系统的临床前评估，将为有效地将MSS从台面转移到床边提供坚实的基础，为患有慢性创面的退伍军人提供临床益处，并改善整体护理。 公共卫生相关性： 卓越的护理是退伍军人管理局的重要使命。慢性伤口，如缺血性伤口和压疮，是许多退伍军人再次住院的主要原因，而且往往与长期住院有关。这一主要的继发性并发症也是退伍军人管理局护理的患者群体中最常见的发病率原因之一。有效和可靠的治疗慢性伤口的技术对于为退伍军人提供最高标准的护理的目标是不可或缺的。电刺激被推荐作为严重慢性创面的一种治疗方式，但其潜在的生理机制尚不完全清楚。这限制了广泛的临床应用。使用有效的动物模型系统地评估电疗的效果，将为有效地将电疗从台面转移到床边提供基础，并改善对患有慢性伤口的退伍军人的整体护理。

DESCRIPTION (provided by applicant): Wounds that fail to heal normally are a major problem for many people with physical impairment and/or disability. These chronic wounds cause significant pain and disability and occur at an alarmingly high frequency in at-risk patient populations. Electrotherapy is the use of electrical stimulation (ES) for treatment of chronic wounds and has long been known but is not reliably effective. The proposed study will determine the physiological mechanisms for effective electrotherapy to provide complete healing of ischemic wounds and use the results of pre-clinical studies to direct rapid implementation in veterans with chronic non-healing wounds. An untethered electronic bandage with all the components of a surface stimulation system mounted on a flexible substrate has been customized for use in this study. This device, known as the Modular Stimulation System (MSS), will be used in throughout the study. A multidisciplinary team of researchers will work together to ensure that this new approach to chronic wound therapy will be highly acceptable to clinical users. Devices will be tested using procedures defined by the Advanced Platform Technology Center Design Control-Quality Systems program, prior to use in a pre-clinical animal model. The MSS will be used in a rat ischemic wound model to evaluate the electrical stimulation variables and treatment durations that will provide the best wound healing This will be defined by several criteria including low inflammation, increased angiogenesis, rapid wound closure and normal scar formation. The effective treatment of chronic wounds is integral to providing the highest standards of health care for veterans. Systematic pre-clinical evaluation of the MSS for electrotherapy of chronic wounds using a valid animal model will provide a strong foundation for effective translation from the benchtop to the bedside to provide clinical benefit for veterans with chronic wound and improve overall care. PUBLIC HEALTH RELEVANCE: Excellence in care is an important mission of the VA. Chronic wounds, such as ischemic wounds and pressure ulcers, are a leading cause of re-hospitalization for many veterans and are often associated with prolonged periods of hospitalization. This major secondary complication is also among the most common cause of morbidity in the patient populations cared for by the VA. Effective and reliable techniques to treat chronic wounds are integral to the goal of providing the highest standards of care for veterans. Electrical stimulation is recommended as a treatment modality for severe chronic wounds, but the underlying physiological mechanisms are not fully understood. This has limited widespread clinical implementation. Systematic evaluation of the effects of electrotherapy using a valid animal model will provide a basis for effective translation from the benchtop to the bedside and improve overall care for veterans with chronic wounds.