University of Michigan Data Coordinating Center for the Diabetic Foot Consortium

密歇根大学糖尿病足联盟数据协调中心

• 批准号: 10614917
• 负责人: Catherine A Spino
• 金额: $ 55.66万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-01 至 2023-03-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10614917
• 关键词: Accounting; Adherence; Adverse event; Architecture; Area; Behavioral; Biological Markers; Budgets; Chronic Disease; Clinical; Clinical Research; Cohort Studies; Collaborations; Collection; Communication; Complement; Complex; Complications of Diabetes Mellitus; Custom; Data; Data Analyses; Data Analytics; Data Collection; Data Coordinating Center; Databases; Diabetes Mellitus; Diabetic Foot; Diagnostic; Disease; Ensure; Esapent; FDA approved; Foot Ulcer; Functional disorder; Goals; Heterogeneity; Infrastructure; Institutional Review Boards; Intervention; Laboratories; Leadership; Learning; Manuals; Methods; Michigan; Modeling; Monitor; National Institute of Diabetes and Digestive and Kidney Diseases; Observational Study; Online Systems; Patients; Preparation; Prevention; Procedures; Protocols documentation; Psychosocial Factor; Recurrence; Reporting; Reproducibility; Research; Research Design; Research Personnel; Risk; Sampling Biases; Science; Secure; Services; Statistical Data Interpretation; Statistical Methods; Subgroup; Support System; System; Techniques; Technology; Teleconferences; Therapeutic; Time; TimeLine; Translating; Translations; Universities; base; bench to bedside; biomarker discovery; biomarker validation; clinical biomarkers; clinical research site; clinically relevant; comorbidity; data management; data standards; design; experience; healing; health care delivery; meetings; member; model design; operation; prevent; programs; recruit; safety study; success; tool; validation studies; web site; webinar

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.

糖尿病相关性足部溃疡（DFUs）是糖尿病的一种普遍且具有破坏性的并发症