Diabetic Foot Ulcer Clinical Research Unit

摘要 我们建议建立一个临床研究单位(CRU)来参与糖尿病足的规划 财团(DFC)。总体目标是参与多点临床研究，以验证生物标志物 用于糖尿病足部溃疡(DFU)。俄亥俄州立大学韦克斯纳医学中心(OSUWMC)综合 创伤中心(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，将提供尖端创新和 竞争激烈的外部资金。OSU非常适合成为拟议的联合体CRU，因为： (1)CWC是一家高产量的临床企业，拥有最有成效的伤口愈合研究之一 该国的方案；(2)非凡的机构支持使化学武器公约能够主办相当规模的慢性 伤口(活检和液体)组织库；(3)已证明的跨学科合作的长期记录，包括 已产生新的非侵入性创伤成像和相关平台的工程；(4) 俄亥俄州立大学教职员工在全国创伤愈合护理和研究领域的领导地位；(5)竞争性 美国国立卫生研究院/国防部在伤口愈合研究方面的资助记录；以及(6)目前有22个基于OSU的伤口愈合 正在进行的试验有2000名积极参加的患者参加。我们建议利用我们当地的资源和专业知识 解决以下三个具体目标：§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，为合格/验证目标DFU生物标记物制定证据标准。 §1.1 CRU领导在伤口愈合方面具有良好的基础/临床/翻译研究记录。§1.2患者 机构中患有糖尿病足溃疡的人群及其伤口护理§1.3以DFU为中心的挑战 特定于DFU生物标记物试验和潜在的解决方案§1.4开发和实施新的策略以监测 并解决与生物标记物研究结果相关的混杂因素。§目标2.确定、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聘和 在整个医疗系统企业中留住目标DFU人群。§2.3确保高效的研究启动， 实施和监督第2.4节。收集、储存和运输DFU样品§2.5确保所有试验的安全和权利 通过高效地安排和完成所有研究程序和临床中心访问。§目标 3.建立CRU管理机构，实现糖尿病足联盟(DFC)的准备工作？3.1建立 领导计划和职责范围。§3.2交流和促进互动。§3.3 旅行§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.