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、致残且昂贵的疾病。它们是由以下因素汇合而成的 影响糖尿病足的神经病变、免疫病变和血管病变。 15-25% 的人患有 糖尿病患者在一生中的某个时刻会出现 DFU，其中高达 20% 的 DFU 会导致严重的疾病 肢体截肢。 DFU 需要大量时间和资源才能治愈，治愈的患者中高达 80% 可能会 发展复发。随着全球糖尿病患病率持续增长，DFU 的负担要求 更有效的预防和治疗方法。分子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，针对 DFU 的有效治疗方法的开发一直在进展。 受到临床试验挑战的阻碍，包括需要更好的分期、经过验证的替代生物标志物， 和标准化终点。 NIDDK 正在成立糖尿病足联盟 (DFC)，以解决糖尿病足问题 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。在这个 在申请中，研究人员提议成立 UCSF 糖尿病足临床研究单位，该单位利用 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 经验丰富的多学科研究人员和工作人员团队。 UCSF 糖尿病足 CRU 包括 加州大学旧金山分校 (UCSF) 医学中心和扎克伯格旧金山综合医院 (ZSFG) 医院作为综合演出场所。它建立在现有的临床和研究专业中心的基础上， 包括加州大学旧金山分校肢体保护中心；加州大学旧金山分校糖尿病中心；加州大学旧金山分校弱势群体中心 人口；加州大学旧金山分校临床与转化科学研究所 (CTSI)；以及 NIDDK 资助的中心 2 型糖尿病转化研究 (CDTR)。研究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，将利用协调管理和 创新的临床研究策略，以实现三个具体目标：i) 招募具有社会经济意义的研究人员 DFU 生物标志物研究的种族多样化和代表性人群； ii) 保留科目 重复测量的纵向队列研究； iii) 高效、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，调查人员还将通过以下方式向 DFC 做出贡献： 建议相关的生物标志物、技术、研究方案和试验设计，以推进临床 DFU 护理科学。