Determination of physiological mechanisms for electrical wound therapy

描述（由申请人提供）： 对于许多身体受损和/或残疾的人来说，无法正常愈合的伤口是一个主要问题。这些慢性伤口会导致严重的疼痛和残疾，并且在高危患者群体中发生的频率高得惊人。电疗法是使用电刺激（ES）来治疗慢性伤口，并且早已为人所知，但并不可靠有效。拟议的研究将确定有效电疗的生理机制，以提供缺血性伤口的完全愈合，并使用临床前研究的结果来指导慢性不愈合伤口的退伍军人的快速实施。在这项研究中使用的一个不受约束的电子绷带与安装在一个灵活的基板上的表面刺激系统的所有组件已被定制。该器械称为模块化刺激系统（MSS），将在整个研究中使用。一个多学科的研究小组将共同努力，以确保这种新的方法，慢性伤口治疗将高度接受临床用户。在用于临床前动物模型之前，将使用高级平台技术中心设计控制-质量体系项目规定的程序对器械进行试验。MSS将用于大鼠缺血性伤口模型中，以评价将提供最佳伤口愈合的电刺激变量和治疗持续时间。这将通过几个标准来定义，包括低炎症、增加的血管生成、快速伤口闭合和正常瘢痕形成。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。使用有效的动物模型对MSS进行慢性伤口电疗的系统临床前评价将为从台式到床边的有效转化提供坚实的基础，为患有慢性伤口的退伍军人提供临床受益并改善整体护理。

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.