Diabetic Foot Ulcer Clinical Research Unit

糖尿病足溃疡临床研究室

• 批准号: 10450904
• 负责人: Gayle M Gordillo
• 金额: $ 17.9万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-23 至 2022-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10450904
• 关键词: Address; Area; Back; Biological Markers; Biopsy; Caring; Clinical; Clinical Research; Communication; Communities; Country; Diabetic Foot; Diabetic Foot Ulcer; Engineering; Enrollment; Ensure; Extramural Activities; Faculty; Fostering; Funding; Health; Health system; Human Resources; Image; Indiana; Infrastructure; Institution; Interdisciplinary Education; Interdisciplinary Study; Leadership; Liquid substance; Mission; Monitor; Outcome Study; Participant; Patients; Population; Procedures; Qualifying; Readiness; Research; Research Personnel; Resources; Rights; Safety; Sampling; Schedule; Ships; Tissue Banks; Training; Translational Research; Travel; United States National Institutes of Health; Universities; Visit; care delivery; chronic wound; clinical center; clinical implementation; clinical research site; clinical translation; innovation; novel; novel strategies; parent grant; patient oriented; patient population; programs; recruit; wound; wound care; wound healing

ABSTRACT (original as submitted) We propose the establishment of a Clinical Research Unit (CRU) to participate in the planned Diabetic Foot Consortium (DFC). The overall objective is to participate in multi-site clinical research to validate biomarkers for diabetic foot ulcers (DFU). The Indiana University Health (IUH) Comprehensive Wound Center (CWC) is founded in 2018 with the mission to transform wound care delivery by developing an interdisciplinary research and education program that would deliver cutting edge innovation and be competitively funded extramurally. IU is ideally suited to become the proposed consortium CRU because: (1) the CWC is a high volume clinical enterprise that hosts one of the most productive wound healing research programs in the country; (2) extraordinary institutional support has enabled CWC investigators to host a sizeable chronic wound (biopsy & fluid) tissue bank; (3) proven long-term track record of interdisciplinary partnership including that with engineering that has resulted in novel non-invasive wound imaging and related platforms; (4) leadership of IU faculty in the community of wound healing care and research nationally; (5) competitive track record in NIH/DoD funding in wound healing research; and (6) at present 22 wound healing trials ongoing with >2000 patients enrolled. We propose to leverage our local resources and expertise to address the following three specific aims: §Aim 1. Provide wound healing expertise and an efficient clinical and scientific infrastructure to develop evidentiary criteria for qualifying/validating the targeted DFU biomarker. §1.1 CRU leaders with strong record of basic/clinical/translation research in wound healing. §1.2 Patient populations with diabetic foot ulcers and their wound care at the institution §1.3 DFU- centric challenges specific to DFU biomarker trial and potential solutions §1.4 Develop and implement novel strategies to monitor and address the confounding factors relevant to biomarker study outcomes. §Aim 2. Identify, enroll and retain patients with DFU. §2.1 Implementation of clinical research. §2.2 Use patient- centered strategies to recruit and retain targeted DFU population across the health system enterprise. §2.3 Ensure efficient study start-up, conduct and monitoring §2.4. Collect, store and ship DFU samples §2.5 Ensure the safety and rights of all trial participants through efficient scheduling and completion of all study procedures and clinical center visits. §Aim 3. Establish CRU administration and achieve Diabetic Foot Consortium (DFC) readiness §3.1 Establish leadership plan and functional areas of responsibilities. §3.2 Communications and fostering interactions. §3.3 Travel §3.4 Succession plan, cross-training and back-up personnel.

摘要(提交原件) 我们建议建立一个临床研究单位(CRU)来参与糖尿病足的规划 财团(DFC)。总体目标是参与多点临床研究，以验证生物标志物 用于糖尿病足部溃疡(DFU)。印第安纳大学健康(IUH)综合创伤中心(CWC)是 成立于2018年，使命是通过发展跨学科研究来改变伤口护理交付 以及将提供尖端创新并获得具有竞争力的外部资金的教育项目。IU 非常适合成为拟议的CRU联盟，因为：(1)CWC是一种大容量临床 企业托管着世界上最有成效的伤口愈合研究项目之一 国家；(2)非同寻常的机构支持使《化学武器公约》调查员能够主持一个相当大的慢性 伤口(活检和液体)组织库；(3)已证明的跨学科合作的长期记录，包括 产生了新的非侵入性创伤成像和相关的工程技术 平台；(4)印第安纳大学教职员工在创伤愈合护理和研究社区的领导 国家；(5)美国国立卫生研究院/国防部在伤口愈合研究方面的竞争记录；(6)目前22 伤口愈合试验正在进行中，有2000名患者参加。我们建议利用我们的本地资源和 解决以下三个具体目标的专门知识：§目标1.提供伤口愈合专门知识和 高效的临床和科学基础设施，为确定/验证目标对象制定证据标准 DFU生物标志物。§1.1 CRU领导，在创伤基础/临床/翻译研究方面有良好记录 治愈。？1.2糖尿病足部溃疡患者群体及其在该机构的伤口护理？1.3 DFU- DFU生物标记物试验的中心挑战和潜在的解决方案§1.4开发和实施新的 监测和解决与生物标记物研究结果相关的混杂因素的战略。§目标2. 识别、登记和保留DFU患者。§2.1临床研究的实施。§2.2使用患者- 以战略为中心，在整个卫生系统企业中招募和留住目标DFU人群。§2.3 确保高效的研究启动、实施和监测第2.4节。收集、储存和运输DFU样品§2.5确保 通过有效安排和完成所有研究程序，确保所有试验参与者的安全和权利 和临床中心的访问。§目标3.建立CRU管理，实现糖尿病足联盟(DFC) 准备情况§3.1建立领导计划和职责的职能领域。§3.2通信和 促进互动。？3.3差旅？？3.4继任计划、交叉培训和后备人员。