University of Michigan Data Coordinating Center for the Diabetic Foot Consortium

糖尿病相关足部溃疡(DFU)是糖尿病的常见和破坏性并发症，很少见 FDA批准的技术和疗法，以促进成功的治愈或预防。糖尿病足 联合会(DFC)代表了美国首个此类多地点临床研究努力，以阐明 促进DFU愈合和防止复发的生物标志物。鉴于已知的多样性和复杂性 导致无法愈合的因素(包括生物标志物、疾病状态、医疗保健提供、干预、 行为和心理社会因素)，六个临床医生的经验和专长的广度和多样性 被选为DFC临床研究单位(CRU)的地点对于实现该联盟的目标至关重要。 严格的设计，伴随着深思熟虑的统计分析，生物标记物验证研究是 对于实现DFC目标也至关重要。拥有20多年经验的密歇根大学数据 协调中心(DCC)汇聚了一个模范的研究小组。DCC调查人员有相关 在糖尿病并发症和慢性疾病的共病建模、设计和分析方面有经验， 生物标记物的发现和验证，以及FDA的合作。强大的统计领导力补充了 DFC的临床和实验室专业知识，加深了对DFU病理生理学的了解 治疗，临床相关结果的传播，以及转化性临床研究的准备。这个 DCC的首要目标是协助和合作临床研究和生物标记物分析单位 调查人员、DFC指导委员会和NIDDK计划工作人员，以使成功实施和 完成DFC批准的临床研究方案，并建议和执行生物标志物验证 分析。 我们将通过以下方式实现这些目标：1)为DFC提供量身定制的基础设施和服务 为了他们的目标。这将确保所有DFC研究的无缝管理和操作，并促进 DFC利益相关方之间的有效沟通。2)我们将确保收集及时、准确和 通过提供高效的专家统计设计，提供可重现的数据并最大限度地遵守研究方案 数据库架构，以及有效的研究协调。3)开展统计数据分析和 使用最新的生物标志物资格，以科学严谨的方式传播研究成果 统计方法。由经验丰富且成就卓著的UM DCC完成这些目标将导致 将已验证的生物标志物从工作台转换到床边，并最大限度地提高 在这一复杂和具有挑战性的治疗领域的联盟。

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.