The clinical and translational research team at the University of Miami (UM) Miller School of Medicine’s Department of Dermatology and Cutaneous Surgery received a 4-year, $1.7 million grant to become 1 of 6 Clinical Research Units (CRU) in the US to help improve outcomes for patients with diabetic foot ulcers. This team approach to research is part of the National Institute of Diabetes and Digestive and Kidney Diseases’ Diabetic Foot Consortium (DFC) for future clinical study of selected biomarkers.
The objective of the DFC is to establish an organizational framework and infrastructure that will serve as a platform for integrated multidisciplinary experimental clinical and translational research. 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. In addition, UM-CRU and DFC 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. It will also establish and maintain a clinical database that will allow overall data analyses of the DFC.