Diabetic Foot Ulcer Clinical Research Unit

糖尿病足溃疡临床研究室

• 批准号: 10201585
• 负责人: Gayle M Gordillo
• 金额: $ 55.13万
• 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 2022-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10201585
• 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; 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 我们建议建立一个临床研究部门（CRU）参加计划中的糖尿病脚 财团（DFC）。总体目标是参与多站点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，其任务是通过开发来改变伤口护理 一个跨学科研究和教育计划，将提供最前沿的创新并成为 竞争性资助外部。 OSU非常适合成为拟议的财团CRU，因为： （1）CWC是一家大量临床企业，它是最有生产力的伤口愈合研究之一 该国计划； （2）非凡的机构支持使CWC能够托管相当大的慢性 伤口（活检和流体）组织库； （3）跨学科合作伙伴关系的长期长期记录 通过工程学导致了新型的非侵入性伤口成像和相关平台； （4） OSU教师在全国范围内的伤口康复和研究社区中的领导； （5）竞争 NIH/DOD资助的记录在伤口愈合研究中； （6）目前22个基于OSU的伤口愈合 > 2000名患者正在进行的试验进行了积极入学。我们建议利用我们的本地资源和专业知识 解决以下三个特定目标：§AIM1。提供伤口愈合专业知识和有效的临床 和科学基础设施，以开发有资格/验证目标DFU生物标志物的证据标准。 §1.1CRU领导者在伤口愈合方面具有良好的基本/临床/翻译研究记录。 §1.2患者 糖尿病足溃疡的人群及其在机构§1.3以DFU为中心的挑战的人口 DFU生物标志物试验和潜在解决方案的特定于第1.4节 并解决与生物标志物研究结果相关的混杂因素。 §AIM2。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招募和 保留卫生系统企业中有针对性的DFU人群。 §2.3确保有效的研究启动， 进行和监视§2.4。收集，存储和运送DFU样品§2.5确保所有审判的安全和权利 通过有效的安排和完成所有研究程序和临床中心访问的参与者。 §目的 3。建立CRU管理并实现糖尿病足联盟（DFC）准备§3.1建立 领导计划和职能领域。 §3.2通信和促进互动。 §3.3 旅行§3.4继任计划，交叉培训和后备人员。