Admin Supplement Request for U01 DK119100-04

U01 DK119100-04 的管理员补充请求

• 批准号: 10641437
• 负责人: Michael S Conte
• 金额: $ 19.05万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2022-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10641437
• 关键词: Address; Area; Biocompatible Materials; Biological Markers; Biosensor; California; Caring; Clinical Research; Clinical Sciences; Clinical Trials; Clinical Trials Design; Collaborations; Data Collection; Development; Diabetes Mellitus; Diabetic Foot; Diabetic Foot Ulcer; Diagnosis; Funding; General Hospitals; Goals; Individual; Institutes; Institution; Limb structure; Longitudinal cohort study; Measurement; Measures; Medical center; Medicine; Molecular Medicine; Morbidity - disease rate; National Institute of Diabetes and Digestive and Kidney Diseases; Neuropathy; Non-Insulin-Dependent Diabetes Mellitus; Operative Surgical Procedures; Participant; Patients; Podiatry; Population; Population Heterogeneity; Prevalence; Prevention; Prognosis; Protocols documentation; Public Health; Recurrence; Research; Research Personnel; Resources; San Francisco; Staging; Standardization; Surrogate Markers; Technology; Time; Translational Research; Universities; Vascular Diseases; Vulnerable Populations; biomarker validation; clinical center; cost; effective therapy; ethnic diversity; experience; healing; improved; innovation; limb amputation; limb loss; mortality; multidisciplinary; novel strategies; patient population; performance site; preservation; recruit; research study; sample collection; socioeconomics; trial design; validation studies; wound healing

PROJECT ABSTRACT Diabetic foot ulcers (DFU) are a common, disabling, and costly condition. They result from a confluence of neuropathy, immunopathy, and vasculopathy that afflict the diabetic foot. Between 15-25% of individuals with diabetes will get a DFU at some point during their lifetime, and up to 20% of these DFUs will lead to a major limb amputation. DFUs require considerable time and resources to heal, and up to 80% of those that heal may develop recurrence. As the global prevalence of diabetes continues to grow, the burden of DFU mandates more effective prevention and treatment approaches. Evolving technologies in areas such as molecular medicine, biomaterials, and biosensors offer opportunities to improve prevention and prognosis, accelerate healing, and reduce recurrence. However, the development of effective treatments for DFU has been hampered by challenges in clinical trials, including the need for better staging, validated surrogate biomarkers, and standardized endpoints. The Diabetic Foot Consortium (DFC) is being established by NIDDK to address this unmet need via a network of Clinical Research Units (CRUs), initially focused on biomarker studies. In this application, the investigators propose the UCSF Diabetic Foot Clinical Research Unit, which leverages a very diverse patient population, world-class institutions for clinical and translational science, and an experienced, multi-disciplinary team of investigators and staff. The UCSF Diabetic Foot CRU includes the University of California, San Francisco (UCSF) Medical Center and Zuckerberg San Francisco General (ZSFG) Hospital as integrated performance sites. It builds upon existing centers of clinical and research expertise, including the UCSF Center for Limb Preservation; the UCSF Diabetes Center; the UCSF Center for Vulnerable Populations; the UCSF Clinical and Translational Science Institute (CTSI); and an NIDDK-funded Center for Type 2 Diabetes Translational Research (CDTR). The investigators bring a broad range of expertise in diabetes, vascular disease, podiatric medicine/surgery, clinical trials, research measurements in ethnically/socio-economically diverse patients, and biomarker and wound healing studies of direct relevance to the goals of the DFC. They propose a Diabetic Foot CRU that will utilize coordinated management and innovative clinical research strategies to address three Specific Aims: i) recruitment of a socio-economically and ethnically diverse and representative population for biomarker studies in DFU; ii) retention of subjects for longitudinal cohort studies with repeated measures; and iii) efficient, quality-controlled, sample and data collection to enable biomarker validation studies. In addition, the investigators will contribute to the DFC by suggesting relevant biomarkers, technologies, and study protocols and trial designs to advance the clinical science of DFU care.

项目摘要 糖尿病足溃疡（DFU）是一种常见的，致残的，昂贵的条件。它们源于 神经病、免疫病和血管病。15-25%的人 糖尿病患者将在其一生中的某个时候获得DFU，这些DFU中高达20%将导致主要的 截肢DFU需要相当多的时间和资源来愈合，高达80%的愈合者可能 发展复发。随着全球糖尿病患病率的持续增长，DFU的负担要求 更有效的预防和治疗方法。在分子生物学等领域不断发展的技术 医学、生物材料和生物传感器为改善预防和预后、加速 治愈，减少复发。然而，DFU的有效治疗方法的发展一直是 受到临床试验挑战的阻碍，包括需要更好的分期，验证的替代生物标志物， 和标准化终点。NIDDK正在建立糖尿病足联盟（DFC），以解决 通过临床研究单位（CRU）网络来满足这一未满足的需求，最初专注于生物标志物研究。在这 应用程序，研究人员建议UCSF糖尿病足临床研究单位，它利用了 非常多样化的患者群体，世界一流的临床和转化科学机构，以及 由经验丰富的多学科调查员和工作人员组成的团队。UCSF糖尿病足CRU包括 加州大学弗朗西斯科分校（UCSF）医学中心和扎克伯格旧金山综合医院（Zuckerberg San弗朗西斯科General） 医院作为综合绩效场所。它建立在现有的临床和研究专业知识中心的基础上， 包括UCSF肢体保护中心; UCSF糖尿病中心; UCSF弱势群体中心 人口; UCSF临床和转化科学研究所（CTSI）;和NIDDK资助的中心， 2型糖尿病转化研究（CDTR）。调查人员带来了广泛的专业知识， 糖尿病、血管疾病、足病医学/外科、临床试验、研究测量 种族/社会经济多样化的患者，以及与以下直接相关的生物标志物和伤口愈合研究 DFC的目标。他们提出了一个糖尿病足CRU，将利用协调管理， 创新的临床研究策略，以解决三个具体目标：i）招募社会经济 DFU中生物标志物研究的种族多样性和代表性人群; ii）保留受试者， 重复测量的纵向队列研究;以及iii）有效的、质量受控的样本和数据 收集以进行生物标志物验证研究。此外，研究人员将通过以下方式为DFC做出贡献： 提出相关的生物标志物、技术、研究方案和试验设计，以推进临床 DFU护理科学