Diabetic Foot Consortium Clinical Research Unit

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SUMMARY We propose the continuation of an established Clinical Research Unit (CRU) towards the success of an established NIDDK-sponsored Diabetic Foot Consortium (DFC). The overall objective of the CRU, established during the previous cycle, was to participate in multi-site clinical research to validate biomarkers for diabetic foot ulcer (DFU) care. Six CRU were funded in cycle 1 (DFC1.0), including IU, of which, four remain as active sites for the ongoing DFC studies. This CRU is high performing per objective metrices presented. This CRU is also a competitively awarded Biomarker Analysis Unit (BAU) – home to the TEWL (Trans-Epidermal Water Loss) study. The TEWL study enrolled the first DFC subject on June 17, 2020, at this CRU. This proposal to renew the IN CRU is aimed at maintaining and exceeding our performance during DFC1.0 which was limited by the pandemic. We are currently the only site with an active CRU, Biomarker Analysis Unit (BAU) and R61/R33- all of which have been independently competitively awarded as part of the DFC. During DFC1.0, IU introduced the inclusion of two local satellite sites within the IU infrastructure as a pilot effort to gauge the impact on patient recruitment and sustainability of managing multiple sites. With supplemental funding support from the DFC, these sites added to the overall productivity of the IU CRU and led to the addition of a third site (Podiatry Associates, IN) outside the IU infrastructure. For cycle 2 (DFC2.0), we will continue to leverage our local resources and expertise and build new satellite network connections to address the following three specific aims: Aim 1. Provide continued wound healing expertise and an efficient clinical and scientific infrastructure to develop evidentiary criteria for qualifying/validating the targeted Diabetic Foot Ulcer (DFU) biomarkers. 1.1 CRU leaders with strong record of basic/clinical/translation research in wound healing. 1.2 Patient populations with DFU, current and further advancement of local Standards of Care. 1.3 Evaluate impact of Social Determinants of Health (SDH) for DFU healing and recurrence. 1.4 Leadership and implementation of the Satellite Pilot Program (SPP). Aim 2. Identify, enroll, and retain patients with DFU. 2.1 Subject identification and enrollment. 2.2 Use patient-centered strategies to recruit and retain targeted DFU patients. 2.3 Ensure timely completion of current cycle protocols (TEWL and c-Myc). 2.4 Ensure efficient conduct and monitoring of ongoing biorepository protocol. 2.5 Ensure efficient study protocol start-up, conduct and monitoring of new R61/33 ancillary protocols. 2.6 Collect, store and ship DFU biosamples. 2.7 Ensure the safety and rights of all trial participants through efficient scheduling and completion of all study procedures and clinical center visits. Aim 3. Support established CRU administration to achieve continued Diabetic Foot Consortium (DFC) readiness 3.1 Support established leadership plan and functional areas of responsibilities. 3.2 Communications & fostering interactions. 3.3 Travel. 3.4 Succession plan, cross-training, and back-up personnel. This CRU is firmly committed to the overall success of the DFC which is a NIH program of transformative significance in DFU care and therefore minimization of amputation.