Diabetic Foot Ulcer Clinical Research Unit

糖尿病足溃疡临床研究室

• 批准号: 10615582
• 负责人: Gayle M Gordillo
• 金额: $ 27.74万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-21 至 2023-03-06
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10615582
• 关键词: Address; Amputation; Area; Back; Basic Science; Biological Markers; Biopsy; Caring; Center for Translational Science Activities; Clinical; Clinical Research; Clinical Sciences; Collaborations; Communication; Communities; Country; Dentistry; Diabetes Mellitus; Diabetic Foot; Diabetic Foot Ulcer; Discipline of Nursing; Electronic Health Record; Engineering; Enrollment; Ensure; Extramural Activities; Faculty; Foot Ulcer; Fostering; Funding; Grant; Health system; Heart; Hospitals; Human Resources; Image; Individual; Infrastructure; Institution; Interdisciplinary Education; Interdisciplinary Study; Laboratory Research; Leadership; Licensing; Limb structure; Liquid substance; Location; Lung; Medical center; Medicine; Metabolism; Mission; Monitor; National Center for Advancing Translational Sciences; Nitrogen; Ohio; Operative Surgical Procedures; Outcome Study; Participant; Patient Care; Patients; Physician Executives; Plastic Surgeon; Population; Procedures; Qualifying; Readiness; Research; Research Institute; Research Personnel; Resources; Rights; Safety; Sampling; Schedule; Science; Ships; Site; Societies; Study Section; Tissue Banks; Training; Translating; Translational Research; Trauma; Travel; United States National Institutes of Health; Universities; Visit; base; care delivery; chronic wound; clinical center; clinical implementation; clinical research site; clinical translation; college; diabetic ulcer; innovation; novel; novel strategies; patient oriented; patient population; preservation; programs; recruit; response; wound; wound care; wound healing

SUMMARY 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 Ohio State University Wexner Medical Center (OSUWMC) Comprehensive Wound Center (CWC) was founded in 2005 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. OSU 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 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 OSU 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 OSU-based wound healing trials ongoing with >2000 patients actively 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.

概括 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 财团（DFC）。总体目标是参与多中心临床研究以验证生物标志物 用于糖尿病足溃疡（DFU）。俄亥俄州立大学韦克斯纳医学中心 (OSUWMC) 综合 伤口中心 (CWC) 成立于 2005 年，其使命是通过开发变革伤口护理服务 跨学科研究和教育计划，将提供尖端创新并成为 竞争性的校外资助。 OSU 非常适合成为拟议的 CRU 联盟，因为： (1) CWC 是一家大批量临床企业，拥有最富有成效的伤口愈合研究之一 国内的计划； (2) 非凡的机构支持使CWC能够举办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良好记录，包括 通过工程开发出新型非侵入性伤口成像和相关平台； (4) 俄勒冈州立大学教师在全国伤口愈合护理和研究领域的领导地位； (5)竞争性 NIH/DoD 在伤口愈合研究方面的资助记录； (6) 目前有 22 个基于 OSU 的伤口愈合 试验正在进行中，超过 2000 名患者积极入组。我们建议利用我们当地的资源和专业知识 实现以下三个具体目标： §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，以制定鉴定/验证目标 DFU 生物标志物的证据标准。 §1.1 CRU 领导者在伤口愈合基础/临床/转化研究方面拥有丰富的记录。 §1.2 患者 患有糖尿病足溃疡的人群及其机构的伤口护理 §1.3 以 DFU 为中心的挑战 针对 DFU 生物标志物试验和潜在解决方案 §1.4 制定和实施新的监测策略 并解决与生物标志物研究结果相关的混杂因素。 §目标 2. 识别、注册和保留 DFU 患者。 §2.1 临床研究的实施。 §2.2 使用以患者为中心的策略来招募和 在整个卫生系统企业中保留目标 DFU 人群。 §2.3 确保高效的研究启动， 行为和监控§2.4。收集、储存和运输 DFU 样本§2.5 确保所有试验的安全和权利 参与者通过有效安排和完成所有研究程序和临床中心访问。 §目的 3. 建立 CRU 管理并为糖尿病足联盟 (DFC) 做好准备 §3.1 建立 领导计划和职能职责范围。 §3.2 沟通和促进互动。 §3.3 旅行 §3.4 继任计划、交叉培训和后备人员。