Image Guidance Method for Diabetic Foot Surgery

描述（由申请人提供）：本项目的总体目标是改善手术治疗骨髓炎的糖尿病患者的护理。这种改进将通过向足病医生和外科医生提供术中成像的即时反馈来实现，以了解手术边缘是否清晰受累，剩余组织是否健康。通常，患者躺在医院病床上，而组织标本的病理评估尚未完成，这增加了总体护理成本，并使患者暴露于潜在的医院感染。一种快速可靠的术中边缘评估方法可以潜在地减少住院时间。提供额外的信心可能会让外科医生和足病医生在手术时更加保守，从而提高患者的生活质量。糖尿病性骨髓炎护理的商业市场估计每年为100亿美元，非骨伤口护理的金额与之相似。该项目利用了最近在小型化荧光显微镜方面的创新，并应用了肿瘤成像方面的经验教训，以实现快速识别骨髓炎患者的手术边缘的目标。该技术的后续应用将在该项目中开发，包括褥疮清创和其他伤口护理挑战。与先前使用外源性造影剂（例如四环素，标记的放射性示踪剂）的成像方法不同，我们建议在这一重要的临床应用中使用内源性光学活性标记（例如线粒体NADH）来快速评估组织活力。该项目的特点是跨领域的学术和工业合作，包括医学成像、伤口护理、传感器工程和物理学方面的专家。从最初的申请开始，根据审稿人的建议，我们小组进行了初步的实验，验证了项目所基于的基本生理假设。这些试点研究的结果包括在修订后的申请中。

DESCRIPTION (provided by applicant): The overall goal of this project is to improve the care of diabetic patients undergoing surgery for treatment of osteomyelitis. This improvement will be attained by providing immediate intraoperative imaging feedback to podiatrists and surgeons as to whether surgical margins are clear of involvement, and whether remaining tissues are healthy. Often, patients reside in hospital beds while pathological assessment of tissue specimens is pending, adding to overall care costs and exposing patients to potential nosocomial infection. A rapid and reliable method of assessing surgical margins intraoperatively could potentially reduce hospital stays. Providing additional confidence might allow surgeons and podiatrists to be more conservative in their resections, thereby improving patients' quality of life. The commercial market for diabetic osteomyelitis care has been estimated at $10 billion annually, with a similar amount for non- bone wound care. The project takes advantage of recent innovations in miniaturized fluorescence microscopes, and applies lessons learned in oncology imaging, towards the goal of rapid identification of surgical margins for osteomyelitis patients. Follow-on applications for the technology to be developed in this project include decubitus ulcer debridement, and other wound care challenges. Unlike prior imaging approaches that employed exogenous contrast materials (e.g., tetracycline, labeled radiotracers) we propose to use endogenous optically-active markers (e.g., mitochondrial NADH) to rapidly assess tissue viability in this important clinical application. The project is distinguished by a cross-cutting academic-industrial collaboration including experts in medical imaging, wound care, and sensor engineering and physics. Since the original application, and in response to the suggestions of the reviewers, our group has conducted preliminary experiments validating the basic physiological assumptions that the project is based on. The results of these pilot studies are included in the revised application. PUBLIC HEALTH RELEVANCE: The overall goal of this project is to improve the care of diabetes patients undergoing surgery for treatment of osteomyelitis. This improvement will be attained by providing immediate intraoperative imaging feedback to podiatrists and surgeons as to whether surgical margins are clear of involvement, and whether remaining tissues are healthy. Often, patients reside in hospital beds while pathological assessment of tissue specimens is pending, adding to overall care costs and exposing patients to potential hospital-acquired infections. A rapid and reliable intraoperative method of assessing surgical margins could potentially reduce hospital stays. Providing additional confidence might allow surgeons and podiatrists to be more conservative in their resections, thereby improving patients' quality of life.