UCSF Diabetic Foot Clinical Research Unit

项目概要/摘要 全球糖尿病患病率持续上升，超过3700万人（占人口的11%） 目前在美国受到影响。这些人中大约有15-20%会经历糖尿病足 溃疡（DFU）在他们生活中的某个时候，对生活质量，发病率和死亡率有重大影响。DFU 是下肢截肢的先兆，每年约有15万美国人发生下肢截肢。 尽管在伤口护理和相关技术方面取得了进展，但DFU的延迟愈合和高复发率 仍然是当前实践中的主要临床挑战，并对患者和患者造成巨大负担。 医疗保健系统。2018年，NIDDK成立了糖尿病足联盟，以解决这一巨大的未满足问题。 需要在DFU受试者中开展高质量、多中心研究，重点是生物标志物开发 和验证。加州大学旧金山分校糖尿病足临床研究单位（CRU）是六个最初参与 在DFC的中心。在其成就中，DFC已经执行了两项正在进行的生物标志物验证 试验，启动了生物储存方案，审查了多项辅助研究提案，目前正在最后确定一项 入组任何早期DFU患者的主方案。在下一个更新期，这些DFC工作将 扩展到包括新的候选生物标志物，通过新的主程序检查护理实践标准 协议，纳入健康的社会决定因素（SDOH），执行辅助研究，并增加 通过卫星站点的参与招募不同人群。 UCSF糖尿病足CRU由两个主要的附属医疗中心组成- UCSF医疗中心和 Zuckerberg San弗朗西斯科综合医院-与湾区的卫星足科诊所相连， 临床研究中心（Center for Clinical Research; CCR）在过去的一年里，我们能够 通过纳入CCR诊所，显著扩大DFC试验的受试者招募。我们还 启动试点可行性研究，将SDOH收集纳入目前正在进行的生物标志物试验（c- Myc和TEWL）。在未来5年的资助期内，我们的跨学科研究团队将进一步 通过激活新的通用主方案（包括所有开放患者），为DFC做出贡献 DFU，纳入SDOH数据的收集，并检查其与结果的关联， 通过增加CCR临床性能研究中心，改善基础设施。

PROJECT SUMMARY/ABSTRACT Diabetes prevalence continues to rise globally, with more than 37 million individuals (11% of the population) currently affected in the United States. Approximately 15-20% of these people will experience a diabetic foot ulcer (DFU) at some point in their lives, with significant impact on quality of life, morbidity, and mortality. DFU are a harbinger of lower extremity amputation which occurs in approximately 150,000 Americans annually. Despite advances in wound care and related technologies, delayed healing and high recurrence rates of DFU remain major clinical challenges in current practice and create an enormous burden on patients and the healthcare system. In 2018 the NIDDK established the Diabetic Foot Consortium to address this large unmet need by execution of high quality, multi-center studies in DFU subjects with a focus on biomarker development and validation. The UCSF Diabetic Foot Clinical Research Unit (CRU) is one of the six initial participating centers in the DFC. Among its accomplishments, the DFC has executed two ongoing biomarker validation trials, initiated a biorepository protocol, reviewed multiple ancillary study proposals, and is currently finalizing a master protocol to enroll any patient with an incipient DFU. In its next renewal period, these DFC efforts will be expanded to include new candidate biomarkers, examine standard of care practices through a new master protocol, incorporate social determinants of health (SDOH), execute ancillary studies, and augment the recruitment of a diverse population by engagement of satellite sites. The UCSF Diabetic Foot CRU consists of two major affiliated medical centers- UCSF Medical Center and Zuckerberg San Francisco General Hospital- linked to satellite podiatry clinics in the Bay Area that share a research umbrella organization (Center for Clinical Research; CCR). Over the last year we have been able to expand subject recruitment for DFC trials dramatically by the incorporation of CCR clinics. We have also initiated pilot feasibility studies to incorporate SDOH collection within the currently ongoing biomarker trials (c- Myc and TEWL). During the next 5 year funding period, our multi-disciplinary research team will further contribute to the DFC by activation of a new common Master Protocol inclusive of all patients with an open DFU, incorporate the collection of SDOH data and examine its associations with outcomes, and expand the infrastructure through the addition of CCR clinical performance sites.