Diabetes-related foot ulcers (DFUs) are prevalent and devastating complications of diabetes, with few FDA-approved technologies and therapies to promote successful healing or prevention. The Diabetic Foot Consortium (DFC) represents the first-of-its-kind multi-site clinical research effort in the US to elucidate biomarkers that promote DFU healing and prevent recurrence. Given the multiplicity and complexity of known factors contributing to non-healing (including biomarkers, disease state, health care delivery, interventions, behavioral and psychosocial factors), the breadth and diversity of experience and expertise of the six clinical sites chosen as DFC clinical research units (CRUs) are essential to achieve the objectives of the consortium. Rigorous design, accompanied by thoughtful statistical analyses, of biomarker validation studies are also critical to accomplish DFC goals. With more than 20 years of experience, the University of Michigan data coordinating center (DCC) brings together an exemplary research group. DCC investigators have relevant experience in diabetes complications and co-morbidity modeling, design and analysis of chronic diseases, biomarker discovery and validation, and FDA collaborations. Strong statistical leadership complements the clinical and laboratory expertise of the DFC, leading to enhanced understanding of the pathophysiology of DFU healing, dissemination of clinically relevant results, and preparation for translational clinical studies. The overarching goal of the DCC is to assist and collaborate with clinical research and biomarker analysis unit investigators, the DFC steering committee, and NIDDK program staff to enable successful implementation and completion of the clinical study protocols approved by the DFC, and advise and execute biomarker validation analyses. We will accomplish these goals through by 1) providing infrastructure and services to the DFC, tailored for their goals. This will ensure seamless study administration and operations for all DFC studies, and promote effective communication among DFC stakeholders. 2) We will ensure the collection of timely, accurate and reproducible data and maximize adherence to study protocols by providing expert statistical design, efficient database architecture, and effective study coordination. 3) We will conduct statistical data analyses and disseminate research findings with scientific rigor for biomarker qualification using the most up-to-date statistical methods. Completion of these aims by a highly experienced and accomplished UM DCC will result in translation of the validated biomarkers from bench to bedside, and maximization of the clinical impact of the consortium in this complex and challenging therapeutic area.
The Diabetic Foot Consortium aims to understand biomarkers that promote healing and prevent recurrence of diabetes-related foot ulcers, a common and devastating complication of diabetes with few treatment options. Proper design and analyses of biomarker validation studies are critical to accomplish these goals. With more than 20 years of experience, the University of Michigan data coordinating center will ensure cutting-edge statistical and operational methods are used in these studies, helping to translate biomarkers from bench to bedside and maximize the clinical impact of the consortium in this complex and challenging therapeutic area.