NIDDK Diabetic Foot Consortium Clinical Research Unit

NIDDK 糖尿病足联盟临床研究单位

基本信息

批准号：
10683425
负责人：
RODICA BUSUI (POP-BUSUI)
金额：
$ 55.54万
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 2027-12-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10683425
关键词：
Adherence Adoption Affect American Amputation Ancillary Study Bioinformatics Biological Biological Markers Caring Cells Clinic Clinical Clinical Data Clinical Protocols Clinical Research Clinical Skills Complications of Diabetes Mellitus Data Data Collection Diabetes Mellitus Diabetic Foot Diabetic Foot Ulcer Eligibility Determination Ensure Evolution Funding Future Genomics Goals Health Care Costs Health system Healthcare Heterogeneity Human Image Image Analysis Incidence Infrastructure Interdisciplinary Study Lead Leadership Lower Extremity Machine Learning Methods Michigan Molecular Molecular Analysis Multi-site clinical study National Institute of Diabetes and Digestive and Kidney Diseases Outcome Participant Patient Outcomes Assessments Patient Recruitments Patients Performance Persons Phenotype Podiatry Policies Precision Health Prevalence Prevention Protocols documentation Publications Recommendation Records Recurrence Research Research Infrastructure Rest Risk Role Sampling Science Site Standardization Techniques Training Translating Translational Research Treatment Cost United States Universities Water Work Writing bench to bedside biobank biological standardization biomarker discovery biomarker validation c-myc Genes clinical practice clinical research site comorbidity cost data mining design diabetes management driving force economic impact foot genetic analysis healing ineffective therapies instrument interdisciplinary approach large datasets member metagenomic sequencing microbiome microbiome analysis mortality novel novel therapeutics pandemic disease patient engagement personalized medicine point of care prediction algorithm predictive marker public health relevance recruit sample collection social health determinants socioeconomics standard care success team-based care tool transcriptomics treatment as usual treatment strategy wound wound care wound healing wound treatment

项目摘要

ABSTRACT Diabetic foot ulcers (DFUs) are a prevalent diabetes complications affecting up to 35% of people with diabetes. Considering the continuous increase in diabetes prevalence and incidence reaching pandemic rates worldwide, the healthcare and socioeconomic impact are staggering, with ~80,000 Americans sustaining non-traumatic amputations each year, and five-year mortality rates of up to 40%. Diabetic foot ulcers (DFUs) costs alone are estimated to add $9 billion-$13 billion per year to the rest of costs to manage diabetes. Additionally, after decades of sustained decline, most recent evidence show that non-traumatic lower extremity amputations in diabetes are now on the rise, despite advances in the standards of diabetes care, recognition for the need of interdisciplinary care teams, and research to target wound care products. Thus, continuing the work and expanding our accomplishments during the first cycle of the Diabetic Foot Consortium (DFC) Clinical Research Unit to validate and implement sensitive DFUs biomarkers at the point of care cannot be understated. The main objectives of the DFU Clinical Research Unit (CRU) at the University of Michigan are to expand the work and activities initiated during the first cycle by integrating the robust DFC infrastructure we built at Michigan with the highly skilled clinical and translational research team to: finalize the ongoing DFU biomarkers protocols; implement the DFC master protocol and its various substudies; continue our high recruitment performance across all ongoing and new biomarker studies; recruit, train and supervise satellite sub sites; develop new methods to stimulate participants engagement and adherence; refine large and standardized biological, imaging, and clinical samples collections, including patient reported outcomes and social determinants of health; analyze how DFU recommended standards of care are implemented into usual care; active and effective participation in DFC self-governing committees. Additionally, will participate in biomarker validation analyses and apply novel discovery tools and analyses including machine learning techniques through a multidisciplinary approach to identify new phenotyping, genomic, molecular and microbiome biomarkers from all DFUs biosamples and wound images to be implemented at point of care. We will also leverage the large and diverse pool of people with diabetes foot complications that receive care at the entire University of Michigan Health System, enabling us to recruit for any ongoing and new DFU studies proposed in the renewal. Our continuous participation as a DFC CRU, will enable us to build upon the state-of -the-art infrastructure, and the high record of success and leadership we established over the past four years to continue to impact progress in all facets of DFUs from research, to personalized treatment implementation and prevention, ultimately contributing to the great success of the entire DFC network.

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 35% 的糖尿病患者。考虑到糖尿病患病率和发病率持续上升，已达到全球大流行率，医疗保健和社会经济影响令人震惊，约有 80,000 名美国人维持非创伤性生活每年都有截肢病例，五年死亡率高达 40%。仅糖尿病足溃疡 (DFU) 的费用就高达据估计，每年管理糖尿病的其余费用将增加 90 亿至 130 亿美元。另外，几十年后最新的证据表明，糖尿病患者非创伤性下肢截肢术的持续下降尽管糖尿病护理标准取得了进步，但人们认识到需要跨学科护理团队，以及针对伤口护理产品的研究。因此，继续工作并扩大我们的糖尿病足联盟 (DFC) 临床研究单位在第一个周期期间取得的成果进行验证并在护理点实施敏感的 DFU 生物标志物，这一点不可低估。密歇根大学 DFU 临床研究中心 (CRU) 的主要目标是扩大通过整合我们在密歇根州建立的强大的 DFC 基础设施，在第一个周期中启动了工作和活动与高技能的临床和转化研究团队合作：完成正在进行的 DFU 生物标志物方案；实现 DFC 主协议及其各种子协议；继续保持我们的高招聘业绩涵盖所有正在进行的和新的生物标志物研究；招募、培训和监督卫星分站；开发新的刺激参与者参与和坚持的方法；完善大型标准化生物、成像、和临床样本收集，包括患者报告的结果和健康的社会决定因素；分析如何将 DFU 建议的护理标准落实到日常护理中；积极有效地参与 DFC 自治委员会。此外，将参与生物标志物验证分析并应用新颖的发现工具和分析，包括通过多学科方法的机器学习技术从所有 DFU 生物样本和伤口中识别新的表型、基因组、分子和微生物组生物标志物在护理点实施的图像。我们还将利用大量多元化的人才糖尿病足并发症在整个密歇根大学医疗系统中得到护理，使我们能够为更新中提议的任何正在进行的和新的 DFU 研究招募人员。我们作为 DFC 的持续参与 CRU 将使我们能够建立在最先进的基础设施以及高成功记录和我们在过去四年中建立的领导力将继续影响 DFU 各方面的进展研究，个性化治疗实施和预防，最终促成巨大成功整个 DFC 网络。