Diabetic Foot Ulcer Clinical Research Unit

摘要（原文提交） 我们建议成立一个临床研究单位（CRU），参与计划中的糖尿病足 财团（DFC）。总体目标是参与多中心临床研究，以验证生物标志物 糖尿病足溃疡（DFU）印第安纳州大学健康（IUH）综合伤口中心（CWC）是 成立于2018年，其使命是通过开发跨学科研究来改变伤口护理服务 和教育计划，将提供尖端的创新，并有竞争力的资助校外。IU 非常适合成为拟议的联合体CRU，因为：（1）CWC是一个高容量的临床 企业主办的最富有成效的伤口愈合研究计划之一，在 （2）特殊的机构支持使《化学武器公约》调查人员能够主持一个相当大的长期 伤口（活检和液体）组织库;（3）跨学科合作伙伴关系的长期记录，包括 随着工程技术的发展， 平台;（4）IU教师在伤口愈合护理和研究社区的领导地位 （5）在伤口愈合研究中NIH/DoD资金的竞争记录;（6）目前22 伤口愈合试验正在进行，招募了>2000名患者。我们建议利用本地资源， 我们的目标是实现以下三个具体目标：目标1。提供伤口愈合专业知识和 有效的临床和科学基础设施，以制定合格/验证目标的证据标准 DFU生物标志物。§1.1 CRU领导人在伤口基础/临床/翻译研究方面有着良好的记录 治愈§1.2糖尿病足溃疡患者人群及其在机构的伤口护理§1.3 DFU- DFU生物标志物试验特有的中心挑战和潜在解决方案§1.4开发和实施新的 监测和解决与生物标志物研究结果相关的混杂因素的策略。§目标2. 识别、入组和保留DFU患者。§2.1临床研究的实施。§2.2使用患者- 以战略为中心，在整个卫生系统企业中招募和留住目标DFU人群。第2.3节 确保有效的研究启动、实施和监查§2.4。收集、储存和运输DFU样品§2.5确保 通过有效安排和完成所有研究程序，确保所有试验参与者的安全和权利 和临床中心访问。§目标3.建立CRU管理并实现糖尿病足联盟（DFC） 准备就绪§3.1建立领导计划和职责职能领域。§3.2通信和 促进互动。§ 3.4继任计划、交叉培训和后备人员。

ABSTRACT (original as submitted) We propose the establishment of a Clinical Research Unit (CRU) to participate in the planned Diabetic Foot Consortium (DFC). The overall objective is to participate in multi-site clinical research to validate biomarkers for diabetic foot ulcers (DFU). The Indiana University Health (IUH) Comprehensive Wound Center (CWC) is founded in 2018 with the mission to transform wound care delivery by developing an interdisciplinary research and education program that would deliver cutting edge innovation and be competitively funded extramurally. IU is ideally suited to become the proposed consortium CRU because: (1) the CWC is a high volume clinical enterprise that hosts one of the most productive wound healing research programs in the country; (2) extraordinary institutional support has enabled CWC investigators to host a sizeable chronic wound (biopsy & fluid) tissue bank; (3) proven long-term track record of interdisciplinary partnership including that with engineering that has resulted in novel non-invasive wound imaging and related platforms; (4) leadership of IU faculty in the community of wound healing care and research nationally; (5) competitive track record in NIH/DoD funding in wound healing research; and (6) at present 22 wound healing trials ongoing with >2000 patients enrolled. We propose to leverage our local resources and expertise to address the following three specific aims: §Aim 1. Provide wound healing expertise and an efficient clinical and scientific infrastructure to develop evidentiary criteria for qualifying/validating the targeted DFU biomarker. §1.1 CRU leaders with strong record of basic/clinical/translation research in wound healing. §1.2 Patient populations with diabetic foot ulcers and their wound care at the institution §1.3 DFU- centric challenges specific to DFU biomarker trial and potential solutions §1.4 Develop and implement novel strategies to monitor and address the confounding factors relevant to biomarker study outcomes. §Aim 2. Identify, enroll and retain patients with DFU. §2.1 Implementation of clinical research. §2.2 Use patient- centered strategies to recruit and retain targeted DFU population across the health system enterprise. §2.3 Ensure efficient study start-up, conduct and monitoring §2.4. Collect, store and ship DFU samples §2.5 Ensure the safety and rights of all trial participants through efficient scheduling and completion of all study procedures and clinical center visits. §Aim 3. Establish CRU administration and achieve Diabetic Foot Consortium (DFC) readiness §3.1 Establish leadership plan and functional areas of responsibilities. §3.2 Communications and fostering interactions. §3.3 Travel §3.4 Succession plan, cross-training and back-up personnel.