Diabetic Foot Consortium Clinical Research Unit

摘要 我们建议继续建立一个临床研究单位(CRU)，以取得成功 成立了NIDDK赞助的糖尿病足联盟(DFC)。CRU的总体目标，已确定 在前一个周期中，是参与多点临床研究，以验证糖尿病足的生物标志物 溃疡(DFU)护理。在周期1(DFC1.0)中资助了6个CRU，其中包括IU，其中4个仍然是活跃的站点 正在进行的DFC研究。该CRU是所提出的每目标矩阵的高性能。这个CRU也是一个 竞争获奖生物标记物分析单位(BAU)-TEWL(跨表皮水分丢失)研究的所在地。 TEWL研究于2020年6月17日在这所CRU招收了第一名DFC受试者。这项更新IN的建议 CRU旨在保持并超越我们在DFC1.0期间的表现，DFC1.0受到大流行的限制。 我们是目前唯一拥有有效CRU、生物标记物分析单元(BAU)和R61/R33的站点--所有这些 作为DFC的一部分，获得了独立的竞争性奖项。在DFC1.0期间，Iu引入了包含 在印第安纳大学基础设施内设立两个当地卫星站点，作为评估对患者招募的影响的试点工作 以及管理多个站点的可持续性。在DFC的补充资金支持下，这些网站 增加了IU CRU的整体生产力，并导致增加了第三个站点(Podiatry Associates，IN) 在IU基础设施之外。对于周期2(DFC2.0)，我们将继续利用我们的本地资源和专业知识 并建立新的卫星网络连接，以满足以下三个具体目标：目标1.提供 持续的伤口愈合专业知识和高效的临床和科学基础设施，以开发证据 目标糖尿病足溃疡(DFU)生物标记物的合格/验证标准。1.1 CRU领导具有强大的 伤口愈合的基础/临床/翻译研究记录。1.2患有DFU的患者群体，当前和 进一步提高当地的护理标准。1.3评估社会健康决定因素(SDH)对 DFU愈合和复发。1.4领导和实施卫星试验计划(SPP)。目标2. 识别、登记和保留DFU患者。2.1科目识别和登记。2.2坚持以患者为中心 招募和留住目标DFU患者的策略。2.3确保及时完成目前的周期方案 (TEWL和c-Myc)。2.4确保有效地执行和监测正在进行的生物信息库协议。2.5确保 有效启动、执行和监测新的R61/33辅助方案的研究方案。2.6收集、存储 并运送DFU生物样本。2.7通过有效的日程安排，确保所有审判参与者的安全和权利 并完成所有研究程序和临床中心访问。目标3.支持已建立的CRU管理 为实现糖尿病足联盟(DFC)的持续准备3.1支持既定的领导计划和 职责的职能领域。3.2交流和促进互动。3.3旅行。3.4继任计划， 交叉培训和后备人员。这个CRU坚定地致力于DFC的全面成功，这是 在DFU护理方面具有变革性意义的NIH计划，因此最大限度地减少了截肢。

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.