DFU Clinical Research Unit

DFU 临床研究单位

• 批准号: 10202575
• 负责人: RODICA BUSUI (POP-BUSUI)
• 金额: $ 54.24万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 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 2022-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10202575
• 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

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（DFUS）是一种普遍的糖尿病并发症，影响多达25％的患者并领导 每年约有80,000名美国人进行非创伤的截肢，五年死亡率高达40％。 最近的证据表明，经过数十年后，非创伤的下肢截肢正在上升 尽管有针对性的伤口护理产品进展，但跨学科临床和 外科团队，改善糖尿病医疗护理。鉴于糖尿病的全球流行病，负担 与DFU有关 发病率高和死亡率。因此，建立一个由 可靠的DFU生物标志物发现的经验丰富的DFU临床研究单元（CRU）不能低估。 该提案的主要目的是将密歇根医学的强大基础设施与我们的高度 熟练的临床和转化团队，建立DFU CRU作为强大的竞争者和贡献者 DFC网络将有唯一准备参加所有DFU生物标志物发现和相关伤口愈合 财团进行的项目。目的是：识别，招募和表型 来自目前有这些疾病的大量患者的大量DFU参与者 根据财团的要求，在密歇根医学上紧随其后；实施标准化 有效的纵向样品收集和保留的机制和方案；并积极参与 DFC在智力上并提供所有可用资源，以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愈合的添加剂预测因子 仅使用多模式方法的临床标记。 这项工作的预期结果是密歇根州医学DFU临床中心将是不可或缺的一部分 联合会协作网络，对整个生物标志物发现的高度积极影响 以及未来的新颖疗法项目。