UCSF Diabetic Foot Clinical Research Unit

项目摘要/摘要 全球糖尿病患病率继续上升，有3700多万人(占总人口的11%) 目前在美国受到影响。其中大约15%-20%的人将经历糖尿病足 溃疡(DFU)在他们生命中的某个阶段，对生活质量、发病率和死亡率有重大影响。DFU 是每年约有15万美国人发生的下肢截肢的先兆。 尽管伤口护理和相关技术取得了进步，但DFU的愈合延迟和复发率高 仍然是当前实践中的主要临床挑战，并给患者和 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得到满足的问题 需要在DFU受试者中进行高质量的多中心研究，重点是生物标记物的开发 和验证。加州大学旧金山分校糖尿病足临床研究中心(CRU)是最初参与的六个项目之一 在DFC的中心。在其成就中，DFC已经执行了两个正在进行的生物标记物验证 试验，启动了生物信息库协议，审查了多项辅助研究提案，目前正在最后敲定一项 登记任何早期DFU患者的主协议。在下一个续订期间，DFC的这些努力将是 扩展到包括新的候选生物标记物，通过新的大师检查护理实践标准 议定书，纳入健康的社会决定因素(SDOH)，执行辅助研究，并加强 通过参与卫星站点招募多样化的人口。 加州大学旧金山分校糖尿病足CRU由两个主要的附属医疗中心组成-加州大学旧金山分校医疗中心和 扎克伯格旧金山综合医院-连接到旧金山湾区的卫星足科诊所，共享 研究伞形组织(临床研究中心；CCR)。在过去的一年里，我们已经能够 通过合并CCR诊所，大幅扩大DFC试验的受试者招募。我们还有 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记物试验(c- MYC和TEWL)。在接下来的5年资助期内，我们的多学科研究团队将进一步 通过激活一项新的公共主协议为DFC做出贡献，该协议包括所有开放的 DFU，纳入SDOH数据的收集并检查其与结果的关联，并扩展 基础设施，通过增加CCR临床表现站点。

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.