University of Miami Clinical Research Unit of the Diabetic Foot Consortium

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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.