The University of Arizona Wound Care Center Clinical Research Unit

亚利桑那大学伤口护理中心临床研究单位

• 批准号: 10683592
• 负责人: GEOFFREY C GURTNER
• 金额: $ 53.66万
• 依托单位: UNIVERSITY OF ARIZONA
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-15 至 2027-12-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10683592
• 关键词: Acceleration; Address; Adherence; Adult; Affect; American; American Indians; Amputation; Ancillary Study; Arizona; Bioinformatics; Biological Markers; Blood Glucose; Blood Vessels; Blood flow; Caring; Cells; Chairperson; Clinical; Clinical Research; Clinical Trials; Clinical Trials Network; Collaborations; Collection; Communities; Community Actions; Complex; Data; Debridement; Dedications; Diabetes Mellitus; Diabetic Foot; Diabetic Foot Ulcer; Education; Educational Status; Environment; Ethnic Origin; FDA approved; Foundations; Funding; Grant; Health; Heterogeneity; Hispanic; Hispanic Populations; Human; Individual; Infrastructure; Institution; International; Intervention; Latino; Limb Salvage; Lower Extremity; Medical; Medicine; Minority; Mission; National Institute of Diabetes and Digestive and Kidney Diseases; Native Americans; Operative Surgical Procedures; Pathologic; Pathology; Patient Care; Patient Recruitments; Patients; Persons; Physicians; Podiatry; Population; Positioning Attribute; Prevalence; Problem Solving; Publications; Recommendation; Recording of previous events; Recurrence; Reporting; Research; Resource Sharing; Role; Sampling; Services; Site; Socioeconomic Status; Source; Surgeon; Techniques; Testing; Tissues; Trauma; United States; United States Indian Health Service; United States National Institutes of Health; Universities; Work; academic program; bench to bedside; biomarker identification; biomarker validation; chronic wound; clinical care; clinical center; clinical research site; college; comorbidity; compliance behavior; contextual factors; demographics; design; diabetic; diabetic patient; diabetic wound healing; drug candidate; experience; healing; higher education; improved; innovation; interdisciplinary approach; limb amputation; mortality; multidisciplinary; open wound; outcome prediction; outreach; outreach program; patient population; predictive marker; prevent; programs; provider adherence; recruit; single-cell RNA sequencing; social; social deprivation; social factors; social health determinants; standard of care; treatment planning; wound; wound care; wound healing

PROJECT SUMMARY Approximately 25% of diabetic patients experience diabetic foot ulcers (DFUs). This is a significant clinical problem since there are no effective biomarkers for predicting outcomes, no drug candidates that have recently been FDA-approved and no therapies that are widely effective in treatment. Additionally, the prevalence of diabetes and non-healing DFUs are highest among minorities, such as in Native American and Hispanic populations, and associated with social deprivation and high mortality. The University of Arizona (UArizona) is the leading public research university in the American Southwest and an ideal transdisciplinary research community for studying DFU healing. The partnership between UArizona and Banner Health provided service to 5,680 patients with open wounds last year. Ranging from trauma to podiatry, Banner Health saw 3,770 individuals with diabetic foot ulcers (DFUs) in the past 3 years. Dr. Geoffrey Gurtner has an established history in studying both late-stage biomarker validation through clinical trials and also mechanistic and early-stage biomarkers identification through the collection of many high-quality biosamples and longitudinal data (Aim 1). This is supported by both the large patient population at UArizona as well as Dr. Gurtner’s history in identifying rate cell subpopulations in DFU samples collected from human patients. Next, we aim to create a unified Standard of Care through the execution of high-quality clinical trials for DFUs, which historically have been difficult to recruit, and also by collecting high-quality data to address the heterogeneity of DFUs with complex pathologies, co-morbidities, and social factors. At UArizona, Dr. Gurtner and Dr. Zhou conduct high-quality clinical trials and have access to a wide distribution of patients and a range of techniques to make sure that “No DFU Patient Goes Unstudied” (Aim 2). Next, our diverse patient pool will allow us to specifically understand how social and environmental contextual factors (“social determinants of health”; SDH) may affect diabetic healing and biomarkers, specifically be recruiting over a diverse and expansive patient pool (Aim 3). Finally, we have access to not just the entire Banner Health Network (BHN), but also to the Indian Health Network and outreach programs for Latino communities. Through this expansive network that incorporates people of all demographics and socio-economic statuses, we will establish effective collaborations between the CRU and new clinical sites to generate cooperative problem-solving and high-level training, with shared resources and values (Aim 4).

项目概要 大约 25% 的糖尿病患者患有糖尿病足溃疡 (DFU)。这是一个具有重大临床意义的 这是一个问题，因为没有有效的生物标志物来预测结果，最近也没有候选药物 已获得 FDA 批准，并且没有广泛有效的治疗方法。此外，普遍存在 糖尿病和无法治愈的 DFU 在少数族裔中最高，例如美洲原住民和西班牙裔 人口，并与社会剥夺和高死亡率有关。 亚利桑那大学（UArizona）是美国西南部领先的公立研究型大学，也是一所 研究 DFU 治疗的理想跨学科研究社区。亚利桑那大学与 Banner Health 去年为 5,680 名开放性伤口患者提供了服务。从外伤到足病治疗， 过去 3 年，Banner Health 发现 3,770 名糖尿病足溃疡 (DFU) 患者。杰弗里·古特纳博士 在通过临床试验研究后期生物标志物验证方面拥有悠久的历史，并且 通过收集许多高质量的生物样本进行机械和早期生物标志物鉴定 和纵向数据（目标 1）。这得到了亚利桑那大学大量患者群体以及 Dr. 的支持。 Gurtner 在识别人类患者 DFU 样本中细胞亚群方面的历史。 接下来，我们的目标是通过对 DFU 进行高质量的临床试验来创建统一的护理标准， 历来很难招募，也可以通过收集高质量的数据来解决 具有复杂病理、合并症和社会因素的 DFU 的异质性。古特纳博士在亚利桑那州 和周博士进行了高质量的临床试验，接触到了广泛的患者和一系列的 确保“没有 DFU 患者未经研究”（目标 2）。接下来，我们多样化的患者库将允许 我们要具体了解社会和环境背景因素（“健康的社会决定因素”； SDH）可能会影响糖尿病的愈合和生物标志物，特别是在多样化和广泛的患者中招募 池（目标 3）。最后，我们不仅可以访问整个 Banner Health Network (BHN)，还可以访问印度 拉丁裔社区的健康网络和外展计划。通过这个广阔的网络 包容各种人口统计和社会经济地位的人们，我们将建立有效的合作 CRU 和新的临床中心之间建立合作解决问题和高水平培训， 共享资源和价值观（目标 4）。