DFU Clinical Research Unit

DFU 临床研究单位

基本信息

批准号：
10220471
负责人：
RODICA BUSUI (POP-BUSUI)
金额：
$ 4.95万
依托单位：
UNIVERSITY OF MICHIGAN AT ANN ARBOR
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/10220471
关键词：
Address Adherence Affect Age American Amputation Area Behavioral Big Data Bioinformatics Biological Biological Markers Blood Caring Cells Clinical Clinical Markers Clinical Research Cohort Studies Collection Complex Complications of Diabetes Mellitus Data Data Collection Databases Devices Diabetes Mellitus Diabetic Foot Diabetic Foot Ulcer Disease End stage renal failure Engineering Epidemic European FDA approved Foot Ulcer Future Gender Genetic Heart failure Heterogeneity Image Image Analysis Individual Infection Infrastructure Institutes Label Liquid substance Location Lower Extremity Machine Learning Marketing Medical Medicine Mental Depression Methodology Michigan Molecular Molecular Analysis Morbidity - disease rate Operative Surgical Procedures Outcome Participant Patient Outcomes Assessments Patient Recruitments Patients Peripheral Nervous System Diseases Peripheral arterial disease Phenotype Positioning Attribute Protocols documentation Psychosocial Factor Publishing Research Personnel Resources Risk Factors Sampling Schools Self Care Standardization Sterile coverings Surface Technology Time Tissue Sample Translational Research Ulcer Universities Vision Walking Work base biomarker discovery clinical center clinical research site cognitive function cohort comorbidity cost diabetic patient experience genetic analysis healing health care delivery improved ineffective therapies interest male metabolomics microbiome microbiome analysis mortality multimodality novel novel therapeutics personalized medicine practice setting precision medicine prediction algorithm prevent prospective public health relevance recruit sample collection tool transcriptomics treatment response wound wound care wound healing

项目摘要

Abstract Diabetic foot ulcers (DFUs) are a prevalent diabetes complications affecting up to 25% of patients and leading to ~80,000 Americans having non-traumatic amputations each year, with five-year mortality rates of up to 40%. Recent evidence suggests that non-traumatic lower extremity amputations are on the rise, after decades of decline, in spite of advances in targeted wound care products, establishment of interdisciplinary clinical and surgical teams, and improving diabetes medical care. Given the worldwide epidemic of diabetes, the burden associated with DFU are high, including high costs of $9 billion-$13 billion per year and besides those associated with high morbidity and mortality. Thus, the establishment of a Diabetic Foot Consortium comprised of experienced DFU Clinical Research Units (CRU) for reliable DFU biomarker discovery cannot be understated. The main objective of this proposal is to integrate the robust infrastructure at Michigan Medicine with our highly skilled clinical and translational team to establish a DFU CRU as a strong contender and contributor within the DFC network that will be uniquely poised to participate in all DFU biomarker discovery and related wound healing projects undertaken by the Consortium. Additional aims are to The aims are to : identify, recruit, and phenotype a broad spectrum of DFU participants from the large base of patients with these conditions who are currently being followed at Michigan Medicine, according to the Consortium requirements; implement standardized mechanisms and protocols for effective longitudinal sample collection and retention; and actively participate in the DFC intellectually and provide all available resources to develop and support clinical study protocols to validate DFU biomarkers, including complex quantifications of wound image features; single cell, genetic, molecular, metabolomics, and microbiome analyses; and assessing additive predictors of DFU healing beyond clinical markers alone using multi-modal approaches. The expected outcome of this work is that the Michigan Medicine DFU Clinical Center will be an integral part of the Consortia collaborative network, with a highly positive impact for the entire spectrum of biomarker discovery and future novel therapies projects.

抽象的糖尿病足溃疡 (DFU) 是一种常见的糖尿病并发症，影响高达 25% 的患者，并导致每年约有 80,000 名美国人接受非创伤性截肢，五年死亡率高达 40%。最近的证据表明，经过数十年的发展，非创伤性下肢截肢呈上升趋势尽管有针对性的伤口护理产品取得了进步，建立了跨学科的临床和外科团队，并改善糖尿病医疗护理。鉴于糖尿病在世界范围内的流行，糖尿病的负担与 DFU 相关的费用很高，包括每年 90 亿至 130 亿美元的高成本，此外具有高发病率和死亡率。因此，成立了糖尿病足联盟，其成员包括经验丰富的 DFU 临床研究单位 (CRU) 在可靠的 DFU 生物标志物发现方面的作用不容低估。该提案的主要目标是将密歇根医学强大的基础设施与我们的高度整合熟练的临床和转化团队将 DFU CRU 建立为强有力的竞争者和贡献者 DFC 网络将以独特的方式参与所有 DFU 生物标志物发现和相关伤口愈合联合体承担的项目。其他目标是：识别、招募和表型来自目前患有这些疾病的大量患者的广泛 DFU 参与者根据联盟的要求，正在密歇根医学进行跟踪；实施标准化有效纵向样本收集和保留的机制和协议；并积极参与 DFC 智力并提供所有可用资源来开发和支持临床研究方案验证 DFU 生物标志物，包括伤口图像特征的复杂量化；单细胞、遗传、分子、代谢组学和微生物组分析；并评估 DFU 愈合的附加预测因子单独使用多模式方法的临床标志物。这项工作的预期成果是密歇根医学 DFU 临床中心将成为联盟协作网络，对整个生物标志物发现领域产生非常积极的影响和未来的新疗法项目。