Diabetic Foot Ulcer Clinical Research Unit

糖尿病足溃疡临床研究室

基本信息

批准号：
9980414
负责人：
Gayle M Gordillo
金额：
$ 43.31万
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：
2018
资助国家：
美国
起止时间：
2018-09-21 至 2022-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9980414
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

项目摘要

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。糖尿病足溃疡 (DFU) 俄亥俄州立大学韦克斯纳医学中心 (OSUWMC) 综合治疗。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 OSU 非常适合成为拟议的联盟 CRU，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 (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记录，包括 (4) 已开发出新型非侵入性伤口成像及相关平台的工程；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) 具有竞争力； NIH/DoD 在伤口愈合研究方面的资助记录；以及 (6) 目前有 22 个基于 OSU 的伤口愈合研究试验正在进行中，有超过 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 领导者在伤口愈合方面具有丰富的基础/临床/转化研究记录。 §1.2 患者。患有糖尿病足溃疡的人群及其在机构中的伤口护理 §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、招募和保留。 §2.1 实施临床研究 §2.2 使用以患者为中心的策略来招募和治疗 DFU 患者。 §2.3 确保有效的研究启动， §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通过有效安排和完成所有研究程序和临床中心访问来帮助参与者。 3. 建立 CRU 管理并为糖尿病足联盟 (DFC) 做好准备 §3.1 建立 §3.2 沟通和促进互动。旅行 §3.4 继任计划、交叉培训和后备人员。