University of Miami Clinical Research Unit of the Diabetic Foot Consortium

摘要 作为对RFA-DK-17-014的回应，我们建议迈阿密大学临床研究中心（UM-CRU）作为 NIH糖尿病足联盟（DFC）的网站，用于选定生物标志物的未来临床研究。客观 的UM-CRU是建立组织框架和基础设施，将作为一个平台， 综合多学科实验临床和转化研究，重点关注糖尿病患者 足部溃疡（DFU）。UM-CRU将与DFC一起制定研究设计和研究方案， 并建立参与者招募和随访、数据收集、质量控制、中期数据 和安全性监测、最终数据分析和解释以及结果公布。此外，UM-CRU 将有助于生物材料（组织样品，拭子，伤口液， 血液、血清和/或尿液）作为未来生物标志物研究的一部分。此外，UM-CRU将建立和 维护临床数据库，以便对DFC进行总体数据分析。创伤愈合临床 迈阿密大学的一个研究小组已经建立了一个成功的，长达数十年的跟踪记录， 针对DFU和其他类型的慢性伤口进行单中心和多中心临床和转化试验。 因此，UM-CRU提供独特的专业知识和基础设施，可以为多中心数据提供平台 （临床和生物学）分析。UM-CRU的总体结构包括建立一个行政 协调UM-CRU活动、监管临床团队、临床研究者团队和 翻译研究单位。UM-CRU的长期目标是为创新领导提供平台 关注DFU患者的新治疗方法和发现。的组合 建立了杰出的临床医生和科学家团队，研究工具，现有资源，能力， UM的支持性环境和协作性专业知识代表了一个独特的环境， 推进DFU相关研究领域。UM-CRU将为所有人提供卓越的临床研究基地 DFC的建议活动。

Abstract In response to RFA-DK-17-014, we propose the University of Miami Clinical Research Unit (UM-CRU) as a site for the NIH Diabetic Foot Consortium (DFC) for future clinical study of selected biomarkers. The objective of UM-CRU is to establish the organizational framework and infrastructure that will serve as a platform for integrated multidisciplinary experimental clinical and translational research focusing on patients with diabetic foot ulcers (DFU). The UM-CRU will, in conjunction with DFC develop the research design and study protocol, and establish protocols for participant recruitment and follow-up, data collection, quality control, interim data and safety monitoring, final data analysis and interpretation, and publication of results. Furthermore, UM-CRU will facilitate procurement, storage and shipment of the biomaterials (tissue samples, swabs, wound fluid, blood, serum and/or urine) as a part of the future biomarker studies. In addition, UM-CRU will establish and maintain clinical data base that will allow overall data analyses of the DFC. The wound healing clinical research team at the University of Miami has established a successful, decades-long track record of conducting single- and multi-center clinical and translational trials for DFU and other types of chronic wounds. Thus, UM-CRU provides unique expertise and infrastructure that can provide a platform for multi-center data (clinical and biological) analyses. The overall structure of UM-CRU includes establishing an Administrative Core to coordinate all aspects of the UM-CRU activities, regulatory clinical team, clinical investigator team and translational research unit. The long-term goal of the UM-CRU is to provide a platform for innovation leading to new therapeutic approaches and discoveries focusing on patients with DFU. The combination of established outstanding group of clinicians and scientists, research tools, existing resources, capabilities, supportive environment and collaborative expertise at UM represents a unique environment to greatly advance the field of DFU related research. UM-CRU will provide outstanding clinical research base for all proposed activities of the DFC.