UCSF Diabetic Foot Clinical Research Unit

加州大学旧金山分校糖尿病足临床研究中心

基本信息

批准号：
10685740
负责人：
Michael S Conte
金额：
$ 55.29万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-09-15 至 2027-12-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10685740
关键词：
Address Affect American Amputation Ancillary Study Area Biological Markers CCR Caring Clinic Clinical Clinical Research Collection Communities Data Data Collection Diabetes Mellitus Diabetic Foot Diabetic Foot Ulcer Education Enrollment Feasibility Studies Funding General Hospitals Goals Healthcare Systems Hospitals Impaired healing Individual Infrastructure Interdisciplinary Study Link Lower Extremity Medical center Minority Groups Morbidity - disease rate Multicenter Studies National Institute of Diabetes and Digestive and Kidney Diseases Observational Study Outcome Parents Patient-Focused Outcomes Patients Persons Podiatry Population Population Heterogeneity Prevalence Protocols documentation Provider Public Health Quality of life Recurrence Research Research Personnel Risk Factors San Francisco Site Specimen Technology United States Vascular Diseases biobank biomarker development biomarker validation c-myc Genes candidate marker clinical care clinical center experience health data health equity improved mortality multidisciplinary performance site recruit social health determinants socioeconomics standard of care wound care

项目摘要

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.

项目概要/摘要全球糖尿病患病率持续上升，超过 3700 万人（占总人口的 11%）目前在美国受到影响。这些人中大约 15-20% 会出现糖尿病足溃疡（DFU）在他们生命中的某个时刻发生，对生活质量、发病率和死亡率产生重大影响。糖尿病足这是下肢截肢的先兆，每年约有 150,000 名美国人发生这种情况。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很高仍然是当前实践中的主要临床挑战，并给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 受试者中执行高质量、多中心研究，重点关注生物标志物的开发和验证。加州大学旧金山分校糖尿病足临床研究中心 (CRU) 是最初参与的六个研究中心之一 DFC 的中心。 DFC 取得的成就包括两项正在进行的生物标志物验证试验，启动了生物样本库方案，审查了多项辅助研究提案，目前正在最终确定用于招募任何早期 DFU 患者的主方案。在下一个更新期间，DFC 的这些努力将扩大到包括新的候选生物标志物，通过新的大师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，并增强通过卫星站点的参与来招募不同的人群。 UCSF 糖尿病足 CRU 由两个主要附属医疗中心组成 - UCSF 医疗中心和扎克伯格旧金山综合医院 - 与湾区的卫星足病诊所相连，共享一个研究伞组织（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。我们还有启动了试点可行性研究，将 SDOH 收集纳入当前正在进行的生物标志物试验中（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个新的通用主协议，包括所有具有开放性的患者，为 DFC 做出贡献 DFU，整合 SDOH 数据的收集并检查其与结果的关联，并扩展通过增加 CCR 临床表现站点来建立基础设施。