NIDDK Diabetic Foot Consortium 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35%的糖尿病患者。 考虑到糖尿病患病率和发病率在全球范围内不断上升， 医疗保健和社会经济影响令人震惊，约有8万美国人没有遭受创伤 每年截肢，五年死亡率高达40%。仅糖尿病足溃疡(DFU)的费用就有 据估计，每年在管理糖尿病的其余成本上增加90亿至130亿美元。此外，几十年后， 在持续下降的情况下，最新的证据表明，糖尿病患者的非创伤性下肢截肢 现在，尽管糖尿病护理标准有所进步，但对跨学科必要性的认识仍在上升 护理团队，以及针对伤口护理产品的研究。因此，继续这项工作，扩大我们的 糖尿病足联盟(DFC)临床研究单位第一周期内的成就验证 并在护理时实施敏感的DFU生物标志物，这一点不能低估。 密歇根大学DFU临床研究部(CRU)的主要目标是扩大 通过集成我们在密歇根建立的强大的DFC基础设施，在第一个周期内启动了工作和活动 与高技能的临床和翻译研究团队：敲定正在进行的DFU生物标记物方案； 执行DFC主协议及其各个子研究；继续我们的高招聘业绩 所有正在进行的和新的生物标记物研究；招募、培训和监督卫星子站；开发新的 刺激参与者参与和坚持的方法；改进大型和标准化的生物、成像、 和临床样本收集，包括患者报告的结果和健康的社会决定因素；分析 如何将DFU建议的护理标准落实到日常护理中；积极和有效地参与 DFC自治委员会。此外，将参与生物标记物验证分析并应用新技术 发现工具和分析，包括通过多学科方法实现的机器学习技术 从所有DFUS生物样本和创伤中识别新的表型、基因组、分子和微生物组生物标志物 要在护理点实施的图像。我们还将利用庞大而多样化的人才库 在整个密歇根大学健康系统接受护理的糖尿病足并发症，使我们能够 招募任何正在进行的和更新中建议的新的DFU研究。我们作为DFC的持续参与 CRU，将使我们能够建立在最先进的基础设施和高记录的成功和 我们在过去四年中建立了领导，以继续影响DFU各方面的进展，从 研究，到个性化治疗的实施和预防，最终促成了巨大的成功 整个DFC网络。

ABSTRACT Diabetic foot ulcers (DFUs) are a prevalent diabetes complications affecting up to 35% of people with diabetes. Considering the continuous increase in diabetes prevalence and incidence reaching pandemic rates worldwide, the healthcare and socioeconomic impact are staggering, with ~80,000 Americans sustaining non-traumatic amputations each year, and five-year mortality rates of up to 40%. Diabetic foot ulcers (DFUs) costs alone are estimated to add $9 billion-$13 billion per year to the rest of costs to manage diabetes. Additionally, after decades of sustained decline, most recent evidence show that non-traumatic lower extremity amputations in diabetes are now on the rise, despite advances in the standards of diabetes care, recognition for the need of interdisciplinary care teams, and research to target wound care products. Thus, continuing the work and expanding our accomplishments during the first cycle of the Diabetic Foot Consortium (DFC) Clinical Research Unit to validate and implement sensitive DFUs biomarkers at the point of care cannot be understated. The main objectives of the DFU Clinical Research Unit (CRU) at the University of Michigan are to expand the work and activities initiated during the first cycle by integrating the robust DFC infrastructure we built at Michigan with the highly skilled clinical and translational research team to: finalize the ongoing DFU biomarkers protocols; implement the DFC master protocol and its various substudies; continue our high recruitment performance across all ongoing and new biomarker studies; recruit, train and supervise satellite sub sites; develop new methods to stimulate participants engagement and adherence; refine large and standardized biological, imaging, and clinical samples collections, including patient reported outcomes and social determinants of health; analyze how DFU recommended standards of care are implemented into usual care; active and effective participation in DFC self-governing committees. Additionally, will participate in biomarker validation analyses and apply novel discovery tools and analyses including machine learning techniques through a multidisciplinary approach to identify new phenotyping, genomic, molecular and microbiome biomarkers from all DFUs biosamples and wound images to be implemented at point of care. We will also leverage the large and diverse pool of people with diabetes foot complications that receive care at the entire University of Michigan Health System, enabling us to recruit for any ongoing and new DFU studies proposed in the renewal. Our continuous participation as a DFC CRU, will enable us to build upon the state-of -the-art infrastructure, and the high record of success and leadership we established over the past four years to continue to impact progress in all facets of DFUs from research, to personalized treatment implementation and prevention, ultimately contributing to the great success of the entire DFC network.