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Stanford Advanced Wound Care Center Clinical Research Unit

斯坦福高级伤口护理中心临床研究部

基本信息

批准号：
10230438
负责人：
GEOFFREY C GURTNER
金额：
$ 4.02万
依托单位：
STANFORD UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-09-15 至 2022-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10230438
关键词：
Address Adherence Amputation Archives Area Big Data Bioinformatics Biological Markers Biomedical Engineering Blood Glucose Blood Vessels Blood flow Caring Clinic Clinical Clinical Research Clinical Treatment Clinical Trials Clinical Trials Unit Clinical and Translational Science Awards Collaborations Communicable Diseases Computer Models Conduct Clinical Trials Country Data Data Set Databases Decision Making Dermatologist Diabetic Foot Diabetic Foot Ulcer Dropout E-learning Education Electronic Health Record Enrollment Ensure Ethnic Origin FDA approved Failure Fellowship Foundations Funding Genomics Growth Healthcare Healthcare Systems Industry Informatics Laboratories Lead Leadership Letters Machine Learning Malignant Neoplasms Measures Medical Medicine Methods Modeling Molecular Monitor National Institute of Diabetes and Digestive and Kidney Diseases Operative Surgical Procedures Outcome Outsourcing Pathology Patient Care Patient Recruitments Patient-Focused Outcomes Patients Pharmaceutical Preparations Phase Physicians Policies Process Provider Publications Publishing Quality of life Radiology Specialty Reporting Research Research Contracts Research Personnel Research Training Resources Running Sampling San Francisco Span 60 Specialist Specimen Surgeon System Testing Translational Research Treatment Protocols Universities Work chronic wound clinical center clinical translation compliance behavior computerized tools data mining demographics design diabetic patient diabetic ulcer drug candidate experience healing health economics implementation science improved interdisciplinary approach large datasets mHealth medical schools member next generation novel novel strategies novel therapeutic intervention outcome prediction patient engagement patient health information patient oriented phase 3 study predictive marker predictive modeling predictive tools prevent programs repository shared decision making single cell analysis sociodemographics standardize measure success treatment adherence treatment planning unstructured data wound wound care wound healing

项目摘要

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. The Stanford Advanced Wound Care Center (AWCC) was opened in 2014 with the sole purpose of facilitating clinical trials, conducting translational research and providing care for patients with chronic wounds. Stanford AWCC receives patients from the University Healthcare Alliance, which spans 60 clinics and 2.5 million people in the San Francisco Bay Area. Despite being in a relatively prosperous area, Stanford AWCC treats patients from diverse socio- demographics. In the past two years, Stanford has treated 6000 patients with wounds, of whom 705 had DFUs. 50% of the patients enroll in clinical trials and there is a very low dropout rate (less than 5%). Under Dr. Geoffrey Gurtner’s leadership, the Stanford AWCC has conducted over 25 clinical trials, where we have measured biomarkers and tested novel therapeutic interventions (Aim 1). It is known that wound healing trials experience a significantly higher failure rate in Phase III studies compared to any other drug trial. This is primarily due to the poorly controlled procedural component of wound care. At Stanford, we address these issues by (i) practicing a multi-disciplinary approach overseen by physicians, (ii) standardizing the measuring and reporting of healing outcomes, (iii) emphasizing rigorous and efficient operational processes during clinical trial conduct and (iv) collaborating with other major academic centers (Aim 2). Looking forward, it is critical to optimize patient engagement during their treatment regimens and inculcate a shared decision-making process. Clinical studies in medical fields such as cancer have indicated that such patient-centered approaches lead to the adherence of treatment regimens and clinical trials. This is currently lacking in with patients with DFUs. With Dr. Arden Morris’s expertise, the Stanford AWCC practices new approaches that centers around the patient, with a focus on improvement in their quality of life (Aim 3). Dr. Nigam Shah, the Director of Bioinformatics at Spectrum, Stanford’s Clinical and Translational Sciences Award has worked with the Stanford AWCC and developed computational tools that predict wound healing outcomes. These models have been developed using data from the Healogics database, the country’s largest network of wound care clinics and a Stanford AWCC operational partner. Dr. Shah also has expertise in analyzing electronic health records of patients from large databases such as TRUVEN and OPTUM, which will allow for the determination of unique biomarkers for wound healing through computational modeling. These models can be executed across the entire Diabetic Foot Consortium (Aim 4).

概括大约 25% 的糖尿病患者患有糖尿病足溃疡 (DFU)。这是一个重要的临床问题是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，并且没有在治疗中广泛有效的疗法。斯坦福高级伤口护理中心 (AWCC) 于 2014 年开业，唯一目的是促进临床试验、开展转化研究并为慢性伤口患者提供护理。斯坦福大学 AWCC 接待患者来自大学医疗保健联盟，该联盟涵盖旧金山湾的 60 家诊所和 250 万人区域。尽管位于相对繁荣的地区，斯坦福大学 AWCC 仍为来自不同社会背景的患者提供治疗人口统计。在过去的两年里，斯坦福大学已经治疗了 6000 名伤口患者，其中 705 名患有 DFU。 50% 的患者参加临床试验，并且退出率非常低（低于 5%）。在博士的领导下在 Geoffrey Gurtner 的领导下，斯坦福大学 AWCC 已进行了超过 25 项临床试验，我们在这些试验中测量生物标志物并测试新颖的治疗干预措施（目标 1）。众所周知，与第三阶段研究相比，伤口愈合试验的失败率明显更高任何其他药物试验。这主要是由于伤口护理的程序部分控制不善。在斯坦福大学，我们通过 (i) 实践由医生监督的多学科方法来解决这些问题，(ii) 标准化治疗结果的测量和报告，(iii) 强调严格和高效临床试验进行期间的操作流程以及 (iv) 与其他主要学术中心的合作（目标 2）。展望未来，优化患者在治疗方案和治疗过程中的参与度至关重要灌输共同的决策过程。癌症等医学领域的临床研究表明这种以患者为中心的方法有助于坚持治疗方案和临床试验。这是目前缺乏 DFU 患者。凭借 Arden Morris 博士的专业知识，斯坦福大学 AWCC 实践以患者为中心的新方法，重点是改善他们的生活质量（目标 3）。 Nigam Shah 博士，斯坦福大学临床和转化科学部 Spectrum 生物信息学主任奖项与斯坦福大学 AWCC 合作，开发了预测伤口愈合的计算工具结果。这些模型是使用来自该国最大的 Healogics 数据库的数据开发的由伤口护理诊所和斯坦福大学 AWCC 运营合作伙伴组成的网络。沙阿博士还拥有以下方面的专业知识从 TRUVEN 和 OPTUM 等大型数据库中分析患者的电子健康记录，这将允许通过计算模型确定伤口愈合的独特生物标志物。这些模型可以在整个糖尿病足联盟中执行（目标 4）。