Diabetic Foot Consortium Clinical Research Unit

总结 我们建议继续建立一个临床研究单位（CRU）， 成立了NIDDK赞助的糖尿病足联盟（DFC）。CRU的总体目标是， 在上一个周期，参与多中心临床研究，以验证糖尿病足的生物标志物 溃疡（DFU）护理。包括IU在内的6个CRU在第1周期（DFC1.0）获得了资助，其中4个仍是活动中心， 正在进行的DFC研究。该CRU根据所提供的目标指标表现出色。这个CRU也是一个 生物标志物分析单元（BAU）-TEWL（经表皮失水）研究的所在地。 TEWL研究于2020年6月17日在该CRU入组了首例DFC受试者。这一更新IN的提议 CRU的目标是在DFC 1. 0期间维持并超越我们的表现，而DFC 1. 0受到疫情的限制。 我们目前是唯一一家拥有活跃的CRU、生物标志物分析单元（BAU）和R61/R33的研究中心， 作为DFC的一部分，独立地进行了竞争。在DFC1.0期间，IU引入了纳入 IU基础设施内的两个当地卫星站点作为试点，以评估对患者招募的影响 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，并增加了第三个研究中心（印第安纳州足科协会） 在基础设施之外。对于第2周期（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，以实现以下三个具体目标：目标1。提供 持续的伤口愈合专业知识和有效的临床和科学基础设施， 用于鉴定/验证靶向糖尿病足溃疡（DFU）生物标志物的标准。1.1 CRU领导人拥有强大的 伤口愈合的基础/临床/翻译研究记录。1.2 DFU患者人群，当前和 进一步提高地方护理标准。1.3评估健康的社会决定因素（SDH）的影响， DFU愈合和复发。1.4领导和实施卫星试验计划。目标2. 识别、入组和保留DFU患者。2.1受试者识别和入组。2.2以病人为中心 招募和留住目标DFU患者的策略。2.3确保及时完成当前周期方案 (TEWL和c-Myc）。2.4确保有效执行和监测正在进行的生物储存方案。2.5确保 有效的研究方案启动、执行和监测新的R61/33辅助方案。2.6收集，储存 并运送DFU生物样本2.7通过高效的时间安排确保所有试验参与者的安全和权利 并完成所有研究程序和临床中心访视。目标3.支持已建立的CRU管理 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， 职责的职能领域。3.2沟通和促进互动。3.3出行3.4继任计划， 交叉培训和后备人员该CRU坚定地致力于DFC的全面成功， 一个在DFU护理中具有变革意义的NIH项目，因此截肢最小化。

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.