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Diabetic Foot Ulcer Clinical Research Unit

糖尿病足溃疡临床研究室

基本信息

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
项目类别：
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

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.

总结