Diabetic Foot Ulcer Clinical Research Unit

糖尿病足溃疡临床研究室

基本信息

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
项目类别：
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

项目摘要

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（提交时的原始内容）我们建议成立临床研究单位（CRU）来参与计划中的糖尿病足研究联盟（DFC）的总体目标是参与多中心临床研究以验证生物标志物。印第安纳大学健康中心 (IUH) 综合伤口中心 (CWC) 负责治疗糖尿病足溃疡 (DFU)。成立于 2018 年，其使命是通过发展跨学科研究来改变伤口护理服务和教育计划，将提供尖端创新并获得印第安纳大学的有竞争力的校外资助。非常适合成为拟议的 CRU 联盟，因为：(1) CWC 临床容量大主办世界上最有成效的伤口愈合研究项目之一的企业国家；(2) 非凡的机构支持使 CWC 调查人员能够主持规模相当大的慢性病伤口（活检和液体）组织库；(3) 跨学科合作伙伴关系的长期记录，包括工程技术已产生新型非侵入性伤口成像和相关技术 (4) 印第安纳大学教员在伤口愈合护理和研究领域的领导力全国范围内；(5) NIH/DoD 在伤口愈合研究方面的资金竞争记录；以及 (6) 目前 22 我们正在进行伤口愈合试验，招募了超过 2000 名患者。旨在实现以下三个具体目标的专业知识： §目标 1. 提供伤口愈合专业知识和高效的临床和科学基础设施，以制定资格/验证目标的证据标准 DFU 生物标志物。§1.1 具有良好伤口基础/临床/转化研究记录的 CRU 领导者。 §1.2 糖尿病足溃疡患者群体及其在机构的伤口护理 §1.3 DFU- DFU 生物标志物试验和潜在解决方案特有的中心挑战 §1.4 开发和实施新颖的监测和解决与生物标志物研究结果相关的混杂因素的策略§目标 2。 §2.1 实施临床研究 §2.2 使用患者。 §2.3 在整个卫生系统企业中招募和留住目标 DFU 人群的集中战略。确保有效的研究启动、实施和监测 §2.4. 收集、储存和运输 DFU 样本 §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 §目标 3. 建立 CRU 管理并建立糖尿病足联盟 (DFC)。准备 §3.1 建立领导计划和职能职责范围 §3.2 沟通和 §3.3 旅行 §3.4 继任计划、交叉培训和后备人员。