DFU Clinical Research Unit

摘要 糖尿病足溃疡（DFU）是一种常见的糖尿病并发症，影响高达25%的患者， 每年约有80，000名美国人接受非创伤性截肢，五年死亡率高达40%。 最近的证据表明，非创伤性下肢截肢正在上升，经过几十年的发展， 下降，尽管有针对性的伤口护理产品的进步，建立跨学科的临床和 手术团队，改善糖尿病医疗护理。鉴于糖尿病在全球范围内的流行， 与DFU相关的成本很高，包括每年90亿至130亿美元的高成本，此外， 发病率和死亡率高。因此，糖尿病足联盟的成立， 经验丰富的DFU临床研究单位（CRU）在可靠的DFU生物标志物发现方面的作用不可低估。 该提案的主要目标是将Michigan Medicine强大的基础设施与我们的高度 熟练的临床和翻译团队，将DFU CRU打造成 DFC网络将以独特的姿态参与所有DFU生物标志物的发现和相关的伤口愈合 由联合体承担的项目。其他目标是：识别、招募和表型 来自目前患有这些疾病的大量患者的广泛DFU参与者 根据联盟的要求，密歇根医学院正在遵循;实施标准化 有效的纵向样本收集和保留的机制和协议;并积极参与 DFC智力和提供所有可用的资源，以制定和支持临床研究方案， 验证DFU生物标志物，包括伤口图像特征的复杂定量;单细胞，遗传， 分子、代谢组学和微生物组学分析;以及评估DFU愈合的附加预测因素， 单独使用多模式方法的临床标志物。 这项工作的预期成果是，密歇根医学DFU临床中心将成为不可分割的一部分， 联盟合作网络，对整个生物标志物发现领域产生了非常积极的影响 和未来的新疗法项目。

Abstract Diabetic foot ulcers (DFUs) are a prevalent diabetes complications affecting up to 25% of patients and leading to ~80,000 Americans having non-traumatic amputations each year, with five-year mortality rates of up to 40%. Recent evidence suggests that non-traumatic lower extremity amputations are on the rise, after decades of decline, in spite of advances in targeted wound care products, establishment of interdisciplinary clinical and surgical teams, and improving diabetes medical care. Given the worldwide epidemic of diabetes, the burden associated with DFU are high, including high costs of $9 billion-$13 billion per year and besides those associated with high morbidity and mortality. Thus, the establishment of a Diabetic Foot Consortium comprised of experienced DFU Clinical Research Units (CRU) for reliable DFU biomarker discovery cannot be understated. The main objective of this proposal is to integrate the robust infrastructure at Michigan Medicine with our highly skilled clinical and translational team to establish a DFU CRU as a strong contender and contributor within the DFC network that will be uniquely poised to participate in all DFU biomarker discovery and related wound healing projects undertaken by the Consortium. Additional aims are to The aims are to : identify, recruit, and phenotype a broad spectrum of DFU participants from the large base of patients with these conditions who are currently being followed at Michigan Medicine, according to the Consortium requirements; implement standardized mechanisms and protocols for effective longitudinal sample collection and retention; and actively participate in the DFC intellectually and provide all available resources to develop and support clinical study protocols to validate DFU biomarkers, including complex quantifications of wound image features; single cell, genetic, molecular, metabolomics, and microbiome analyses; and assessing additive predictors of DFU healing beyond clinical markers alone using multi-modal approaches. The expected outcome of this work is that the Michigan Medicine DFU Clinical Center will be an integral part of the Consortia collaborative network, with a highly positive impact for the entire spectrum of biomarker discovery and future novel therapies projects.