Diabetic Foot Ulcer Clinical Research Unit

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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.