University of Michigan Data Coordinating Center for the Diabetic Foot Consortium

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Diabetes-related foot ulcers (DFUs) are prevalent and devastating complications of diabetes, with few FDA-approved therapies. The Diabetic Foot Consortium (DFC) was established in 2018 as the first multi-site US clinical research effort to elucidate biomarkers that promote DFU healing and prevent recurrence. The multiplicity and complexity of known factors contributing to poor outcomes require the diversity of experience and expertise of the four DFC clinical research units (CRUs), the biomarker analysis units (BAUs), and the University of Michigan (UM) data coordinating center (DCC) to achieve the scientific objectives of the DFC. The DCC brings over 23 years of experience in statistical and operational leadership of complex studies and networks, leveraging specific experience in diabetes complications and co-morbidity modeling, design and analysis of chronic diseases, biomarker discovery and validation, and FDA collaborations. The DCC’s leadership in these areas complements the clinical and laboratory expertise of the DFC. Together we will identify important and reliable biomarkers that predict DFU healing and recurrence and study the association of patient and physician characteristics with good DFU outcomes. In our first 3 years, the DCC has built successful and durable partnerships with CRU and BAU investigators and NIDDK scientists to implement two biomarker validation studies and a biorepository study that collects biospecimens for future research. We will continue this partnership to complete these complex studies and finalize a platform study in patients with open DFUs that will support future biomarker studies, as well further our knowledge of the impact of standard of care therapies and social determinants of health on DFU outcomes. These activities will lay the foundation for future trials leading to better care and health outcomes for patients with DFUs. We will accomplish these goals by: 1) providing tailored infrastructure and services to ensure seamless administration and operations for all DFC studies and facilitate effective communication among DFC stakeholders; 2) ensuring the collection of timely, accurate and reproducible data and high-quality biospecimens and maximizing adherence to study protocols by providing expert statistical design, efficient database architecture, and effective study coordination; 3) applying state-of-the-art bioinformatics and statistical methods to analyze biomarker qualification, to detect important patient characteristics associated with good clinical outcomes, and to identify testable hypotheses to guide care for subpopulations of patients with DFUs. 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 improvements in standard of care based on comprehensive patient, foot ulcer and treatment data. Collaboration among the CRUs, BAUs, satellite sites, ancillary study investigators, NIDDK and DCC will maximize the scientific and clinical impact of the Consortium in this complex and challenging therapeutic area.