DFU Clinical Research Unit

DFU 临床研究单位

• 批准号: 10377784
• 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
• 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/10377784
• 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.

摘要