Diabetic Foot Ulcer Clinical Research Unit

总结 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）俄亥俄州州立大学韦克斯纳医学中心（OSUWMC）综合 伤口中心（CWC）成立于2005年，其使命是通过开发 一个跨学科的研究和教育计划，将提供尖端的创新， 竞争性的资助。OSU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，主持最富有成效的伤口愈合研究之一 （2）特殊的机构支持使CWC能够举办相当大的长期活动， 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 通过工程技术，产生了新型非侵入性伤口成像和相关平台;（4） OSU教师在全国伤口愈合护理和研究社区的领导地位;（5）竞争力 NIH/DoD在伤口愈合研究中的资金记录;（6）目前22个基于OSU的伤口愈合 正在进行的试验，积极招募了>2000名患者。我们建议利用我们的本地资源和专业知识 具体目标有三个：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，以开发用于鉴定/验证靶向DFU生物标志物的证据标准。 §1.1 CRU领导人在伤口愈合的基础/临床/翻译研究方面具有良好的记录。§1.2患者 糖尿病足溃疡人群及其在机构中的伤口护理§1.3以DFU为中心的挑战 特定于DFU生物标志物试验和潜在解决方案§1.4制定和实施新的监测策略 并解决与生物标志物研究结果相关的混杂因素。§目标2.识别、登记和保留 DFU患者§2.1临床研究的实施。§2.2使用以患者为中心的策略招募和 在整个卫生系统企业中保留目标DFU人群。§2.3确保有效的研究启动， 行为和监测§2.4。收集、储存和运输DFU样品§2.5确保所有试验的安全和权利 参与者通过有效的时间安排和完成所有研究程序和临床中心访视。§目标 3.建立CRU管理并实现糖尿病足联盟（DFC）准备§3.1建立 领导计划和职责领域。3.2沟通和促进互动。§3.3 差旅§3.4继任计划、交叉培训和后备人员。

SUMMARY 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 Ohio State University Wexner Medical Center (OSUWMC) Comprehensive Wound Center (CWC) was founded in 2005 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. OSU 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 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 OSU 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 OSU-based wound healing trials ongoing with >2000 patients actively 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.