Diabetic Foot Consortium Clinical Research Unit

糖尿病足联盟临床研究单位

• 批准号: 10685135
• 负责人: Gayle M Gordillo
• 金额: $ 11.01万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-21 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10685135
• 关键词: Active Sites; Address; American; Amputation; Area; Award; Biological Markers; Caring; Clinical; Clinical Research; Communication; Darkness; Dedications; Diabetes Mellitus; Diabetic Foot; Diabetic Foot Ulcer; Discipline; Enrollment; Ensure; Environment; Exclusion Criteria; Extramural Activities; Foot Ulcer; Fostering; Funding; Goals; Health; Health system; Home; Hospitals; Human Resources; Indiana; Individual; Infrastructure; Institution; Interdisciplinary Education; Interdisciplinary Study; Leadership; Methodist Church; Mission; Monitor; National Institute of Diabetes and Digestive and Kidney Diseases; Nomenclature; Participant; Patient Recruitments; Patient-Focused Outcomes; Patients; Performance; Podiatry; Procedures; Productivity; Protocols documentation; Qualifying; Readiness; Recurrence; Resources; Rights; Safety; Schedule; Secure; Site; Time; Training; Translational Research; Travel; United States National Institutes of Health; Universities; Visit; Water; biobank; biomarker validation; c-myc Genes; care delivery; care providers; clinical center; clinical research site; cost; experience; healing; improved; innovation; medical schools; pandemic disease; patient oriented; patient population; patient retention; programs; recruit; response; social health determinants; success; wound; wound care; wound healing

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.

概括 我们建议持续建立的临床研究部门（CRU）成功 已建立的NIDDK赞助的糖尿病足财团（DFC）。 CRU的总体目标建立 在上一个周期中，将参加多站点临床研究以验证生物标志物的糖尿病脚 溃疡（DFU）护理。六个CRU在第1周期（DFC1.0）中资助，其中包括IU，其中有四个作为主动地点。 正在进行的DFC研究。该CRU的每个物镜指标表现很高。这个CRU也是一个 竞争性地授予生物标志物分析单位（BAU） - TEWL（跨性皮水损失）研究的所在地。 TEWL研究于2020年6月17日在此CRU上招收了第一个DFC主题。此提议续签 CRU旨在在DFC1.0期间维持和超过我们的性能，而DFC1.0受到了大流行的限制。 我们目前是唯一一个有活跃的CRU，生物标志物分析单元（BAU）和R61/R33的站点 作为DFC的一部分，已独立竞争授予。在DFC1.0期间，IU引入了包含 IU基础设施中的两个本地卫星站点的试点努力，以评估对患者招聘的影响 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的整体生产率，并导致了第三个站点（Podiathy Associates，IN） 在IU基础架构之外。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解决以下三个特定目标：AIM 1。 持续的伤口愈合专业知识以及有效的临床和科学基础设施，以发展证据 鉴定/验证目标糖尿病足溃疡（DFU）生物标志物的标准。 1.1强大的CRU领导人 伤口愈合中基本/临床/翻译研究的记录。 1.2 DFU，电流和 进一步发展当地护理标准。 1.3评估社会决定因素（SDH）的影响 DFU治愈和复发。 1.4卫星试点计划（SPP）的领导和实施。目标2。 识别，注册和保留DFU患者。 2.1主题识别和注册。 2.2使用以患者为中心的 招募和保留目标DFU患者的策略。 2.3确保及时完成当前周期协议 （TEWL和C-MYC）。 2.4确保有效的行为和监视正在进行的生物座位方案。 2.5确保 有效的研究方案启动，进行新的R61/33辅助方案的进行和监视。 2.6收集，存储 并运送DFU生物样本。 2.7通过有效的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。支持既定的CRU管理 为了实现持续的糖尿病足财团（DFC）准备3.1支持既定领导计划和 职能领域。 3.2通信和促进互动。 3.3旅行。 3.4继任计划， 交叉训练和后备人员。该CRU首先致力于DFC的整体成功 NIH在DFU护理中具有变革意义的计划，因此截肢最小化。