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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：
9980389
负责人：
GEOFFREY C GURTNER
金额：
$ 43.18万
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/9980389
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).

总结