Diabetic Foot Consortium Clinical Research Unit

糖尿病足联盟临床研究单位

• 批准号: 10892442
• 负责人: Gayle M Gordillo
• 金额: $ 45.56万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 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 2027-12-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10892442
• 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 我们建议继续建立已建立的临床研究单位 (CRU)，以取得成功 成立 NIDDK 赞助的糖尿病足联盟 (DFC) 确定了 CRU 的总体目标。 在上一个周期中，是参加多中心临床研究以验证糖尿病足的生物标志物 溃疡 (DFU) 护理在第 1 周期 (DFC1.0) 中获得了资助，其中包括 IU，其中 4 个仍作为治疗的活性部位。 正在进行的 DFC 研究。该 CRU 根据所提出的目标指标表现良好。 荣获竞争奖项的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 上注册了第一个 DFC 受试者。 CRU 的目标是维持并超越 DFC1.0 期间受疫情限制的表现。 我们是目前唯一拥有活跃 CRU、生物标志物分析单元 (BAU) 和 R61/R33 的站点 - 所有这些 已作为 DFC 的一部分独立竞争授予。在 DFC1.0 期间，IU 引入了纳入内容。 印第安纳大学基础设施内的两个当地卫星站点作为试点工作，旨在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，这些站点。 提高了 IU CRU 的整体生产力，并导致增加了第三个站点（足病学协会，印第安纳州） 在 IU 基础设施之外，对于第二周期 (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以及有效的临床和科学基础设施来开发证据 鉴定/验证目标糖尿病足溃疡 (DFU) 生物标志物的标准 1.1 具有强大的 CRU 领导者。 伤口愈合的基础/临床/转化研究记录 1.2 当前和未来 DFU 患者群体。 进一步提高当地护理标准 1.3 评估健康社会决定因素 (SDH) 对健康的影响。 DFU 的治愈和复发。 1.4 卫星试点计划（SPP）的领导和实施。 识别、登记和保留 DFU 患者 2.1 受试者识别和登记 2.2 以患者为中心。 2.3 确保及时完成当前周期协议 （TEWL 和 c-Myc） 2.4 确保有效执行和监控正在进行的生物样本库方案。 有效的研究方案启动、实施和监测新的 R61/33 辅助方案 2.6 收集、存储。 2.7 通过有效的调度确保所有试验参与者的安全和权利。 目标 3. 支持已建立的 CRU 管理。 持续为糖尿病足联盟 (DFC) 做好准备 3.1 支持既定的领导计划和 3.2 沟通和促进互动 3.4 继任计划。 该 CRU 坚定地致力于 DFC 的整体成功。 美国国立卫生研究院 (NIH) 的一项计划对糖尿病足溃疡 (DFU) 护理具有变革意义，从而最大限度地减少截肢。