Non-contact Diffuse Optical Assessment of Pressure Ulcer and Therapy

描述(由申请人提供)：压疮影响100-300万美国成年人。长时间的压力会导致外周循环不良和组织缺氧，并可能导致严重的组织损伤。电刺激(ES)作为一种辅助治疗方法，与传统的溃疡治疗方法相比，具有劳动强度小、成本低等优点。然而，ES参数通常是随意选择的，治疗结果是通过对组织质量和/或伤口体积变化的可见估计来评估的，而不是通过溃疡组织的内在血流动力学变化来评估的。早期发现压疮是有效的溃疡管理和降低后续治疗成本的关键。由于压疮通常起源于附着在骨骼上的深层组织(例如，臀部肌肉围绕着骶骨)，因此测量深层组织的血流动力学对于溃疡的早期诊断和ES治疗的优化至关重要。然而，目前还没有简单的方法能够检测深层组织中溃疡发展的早期阶段。一种新的先进技术，近红外漫反射光学，可以使用光纤探头轻轻接触皮肤表面，非侵入性地监测深层组织(长达几厘米)的血液流动和氧合，最近在我们的初步研究中得到了证明。然而，使用接触式探头测量组织血流动力学并不适用于容易感染的溃疡组织。这项拟议的项目是开发和验证一种新的非接触式漫反射光学系统(AIM 1)，用于早期评估深部组织溃疡的血流动力学。这种非接触式系统将完全避免探头-组织接触引起的组织变形和潜在的感染。这项研究还将把非接触式系统与ES刺激器相结合，用于压疮的治疗和治疗监测。集成的非接触式系统在健康肌肉中得到验证，并且ES治疗参数经过优化以最大限度地提高组织血流动力学对ES的响应后(目标2)，该非接触式光学系统将被用于检测有或无压疮(I-IV期)患者在ES治疗前、中及之后4周(目标3)臀部肌肉中的血流和组织氧合情况。预计影响组织损伤/愈合的深部组织血流动力学的测量将为溃疡的早期诊断、ES参数的客观优化和ES治疗效果的纵向评估提供独特的价值。我们的长期目标是对来自多个康复中心的具有统计意义的人群进行广泛的研究，以转化这一创新的集成系统并将其商业化，以有效地进行压疮的临床管理。考虑到长期护理压疮的健康负担，这一转化性技术项目有可能显著提高我们对压疮发展和治疗的理解，最终显著改善人类健康并节省大量成本。

DESCRIPTION (provided by applicant): Pressure ulcers affect 1-3 million American adults. Prolonged pressure results in poor peripheral circulation and tissue hypoxia, and may cause significant tissue damage. As one of the adjunctive therapies, electrical stimulation (ES) is less labor intensive with lower costs compared to conventional therapies for ulcer treatment. However, ES parameters are often selected arbitrarily and treatment outcomes are evaluated by visible estimates of tissue mass and/or wound volume changes rather than intrinsic hemodynamic changes in ulcerous tissues. Early detection of pressure ulcers is the key for effective ulcer management and for reducing subsequent treatment costs. Since pressure ulcers usually originate from deep tissues attached to the bone (e.g., gluteal muscles surrounding the sacrum), measurement of deep tissue hemodynamics is essential for early diagnosis of ulcers and for optimization of ES treatment. However, no easy methods exist yet that are able to detect the early stages of ulcer development in deep tissues. A new advanced technology, near- infrared diffuse optics, can noninvasively monitor blood flow and oxygenation in deep tissues (up to several centimeters) with fiber-optic probes that gently contact the skin surface, and has recently been demonstrated in our preliminary studies. However, measurements of tissue hemodynamics using contact probes are not appropriate for ulcerous tissues that are prone to infection. This proposed project is to develop and validate a novel non-contact diffuse optical system (Aim 1) for early hemodynamic assessment of ulcer development in deep tissues. This non-contact system will completely avoid tissue deformation and potential infections induced by probe-tissue contact. This study will also integrate the non-contact system with an ES stimulator for treatment and therapeutic monitoring of pressure ulcers. After the integrated non-contact system is validated in healthy muscles and ES treatment parameters are optimized to maximize tissue hemodynamic responses to ES (Aim 2), the non-contact optical system will be used to detect blood flow and tissue oxygenation in gluteal muscles surrounding the sacrum in patients with or without pressure ulcers (stages I-IV) before, during and after ES treatments over 4 weeks (Aim 3). It is expected that measurement of deep tissue hemodynamics that affect tissue damage/healing will provide unique value for the early diagnosis of ulcer development, the objective optimization of ES parameters, and the longitudinal evaluation of ES treatment effects. Our long-term goal is to conduct extensive studies on statistically significant populations from multiple rehabilitation centers to translate and commercialize this innovative integrated system for the effective clinical management of pressure ulcers. Given the health burden of long-term care for pressure ulcers, this translational technology project has the potential to significantly advance our understanding of pressure ulcer development and treatment, ultimately leading to significant improvements in human health and substantial cost savings.