Clinical Research Center to Decrease Limb Amputation Rate in People with Diabetes

降低糖尿病患者截肢率的临床研究中心

• 批准号: 8327112
• 负责人: HAROLD BREM
• 金额: $ 13.09万
• 依托单位: NYU WINTHROP HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-01 至 2016-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8327112
• 关键词: Address; Affect; Amputation; Area; Attention; Award; Behavioral; Biological; Biological Markers; Blood; Bone Marrow; Caring; Chronic; Clinic; Clinical; Clinical Informatics; Clinical Investigator; Clinical Research; Clinical Sciences; Clinical Trials; Clinical Trials Design; Community Hospitals; Complex; Complications of Diabetes Mellitus; Computerized Medical Record; Correlation Studies; Country; Data; Data Base Management; Data Sources; Databases; Development; Diabetes Mellitus; Diabetic Foot; Diabetic Foot Ulcer; Digit structure; Effectiveness; Elderly; Emotional Stress; Ethics; Ethnic Origin; Faculty; Funding; Generations; Goals; Grant; Graph; Healed; Healthcare; Hospitals; Hydrocortisone; Individual; Institutes; Intervention; Investigation; Laboratories; Lead; Learning; Life; Limb structure; Lower Extremity; Master of Science; Measures; Medical; Medical Informatics; Medical Students; Medical center; Mentors; Mentorship; Microbiology; Military Personnel; Minority; Minority Groups; Molecular; Multi-Institutional Clinical Trial; National Institute of Diabetes and Digestive and Kidney Diseases; New York; Online Systems; Operative Surgical Procedures; Orthopedics; Outcome; Outpatients; Pathology; Patients; Persons; Pharmaceutical Preparations; Phase; Population; Postdoctoral Fellow; Race; Randomized; Reporting; Request for Applications; Research; Research Infrastructure; Research Personnel; Research Project Grants; Risk; Role; Scientist; Serum; Site; Stem cells; Stress; Structure; Students; Subgroup; Testing; Therapeutic; Time; Tissues; Toes; Training; Translating; Translational Research; Treatment outcome; United States Department of Veterans Affairs; United States National Institutes of Health; Universities; Urban Hospitals; Use Effectiveness; Work; Wound Healing; arthropathies; biological adaptation to stress; c-myc Genes; clinical care; cohort; database design; design; diabetic patient; effectiveness measure; evidence base; foot; glycemic control; healing; improved; inner city; interdisciplinary approach; interest; medical schools; molecular marker; mortality; novel; patient oriented; patient oriented research; point of care; population based; prevent; programs; standard of care; tertiary care; tool; treatment strategy; wound

DESCRIPTION (provided by applicant): The long-term goal of the candidate's research program is to reduce lower-limb amputations resulting from chronic non-healing diabetic foot ulcers (DFUs). The objective of this K24 Midcareer Investigator Award, is to provide additional time that is protected from clinical and administrative responsibilities so that the candidate can devote 30% effort on his mentoring program for post-doctoral fellows, in addition to medical students and junior faculty. This work is all in the New York University School of Medicine, Helen & Martin Kimmel Division of Wound Healing, which is interested in diabetes patient-oriented research (POR). The candidate's clinical diabetes research program, funded by NIDDK since 2002, focuses on translating scientific investigation into decreased limb loss for people with diabetes. Current research focuses on advancing use of a patient-centered Online Wound Electronic Medical Record (OWEMR) with clinical decision support as a medical informatics intervention tool to decrease limb loss. Two current R01 grants and one RC1 grant fund research to develop evidence-based patient-focused treatment strategies that address three separate but related facets of DFU treatment: 1) use of the OWEMR as an intervention tool along with the current standard of care to reduce DFU-related lower limb amputations, 2) correlation of the molecular biomarkers, c-myc and 2-catenin, with healing of diabetic foot ulcers; and 3) correlation of DFU healing rate with markers of emotional stress, such as increased blood cortisol levels and behavioral stress responses. The candidate's current research incorporates medical students, postdoctoral fellows and junior faculty into all aspects of a randomized multi center trial. The sixteen participating diabetic foot ulcer centers across the country are either university-affiliated hospitals, community medical centers, inner city hospital centers, Veterans Administration hospitals, or military healthcare centers. The mentees will learn how to test the effectiveness of using the OWEMR with clinical decision support, as an intervention tool to reduce lower limb amputations resulting from DFUs. Study sites will be randomized to implement the OWEMR and clinical decision support as an intervention versus standard of care. All participating medical centers have large outpatient diabetic foot care clinics that treat a broad population base with substantial cohorts of racial and ethnic minorities and elderly individuals, which will permit subset analysis of treatment outcomes in these cohorts. Completion of this study will generate a novel comprehensive diabetic foot ulcer database of clinical information that can be used to identify factors that are correlated with healing outcomes. This large clinical study provides a unique opportunity to mentor postdoctoral fellows and junior faculty in POR conducted in a "real life" treatment setting on a widespread serious and complex medical problem. This mentorship program has the following features at NYU School of Medicine: 1) all clinical trials use the same comprehensive diabetes database, 2) internal and external mentors are dedicated specifically to diabetic foot ulcer research, 3) new clinical trials are in development, including the use of bone marrow derived stem cells to treat diabetic foot ulcers, 4) there are multisite studies within NYU that are comprised of a large tertiary care hospital (Tisch), a Veterans Administration Hospital (Manhattan VA), an orthopedic hospital (Hospital for Joint Disease), and an inner city hospital (Bellevue); and 5) The Clinical and Translational Science Institute is NIH-funded and provides clinical research infrastructure in addition to an opportunity for mentees to pursue a Master's of Science degree in Clinical Investigation.

描述（由申请人提供）：候选人的研究计划的长期目标是减少下肢截肢造成的慢性非愈合糖尿病足溃疡（DFU）。这个K24中期职业生涯研究者奖的目的是提供额外的时间，免受临床和行政责任的保护，使候选人可以投入30%的精力在他的博士后导师计划上，除了医学生和初级教师。这项工作都是在纽约大学医学院，海伦和马丁金梅尔伤口愈合部门，这是在糖尿病患者为导向的研究（POR）感兴趣。候选人的临床糖尿病研究计划，自2002年以来由NIDDK资助，重点是将科学研究转化为减少糖尿病患者的肢体损失。目前的研究重点是推进以患者为中心的在线伤口电子病历（OWEMR）的使用，并提供临床决策支持，作为减少肢体丧失的医疗信息学干预工具。目前的两项R 01赠款和一项RC 1赠款资助研究，以开发基于证据的以患者为中心的治疗策略，解决DFU治疗的三个独立但相关的方面：1）使用OWEMR作为干预工具，沿着当前的护理标准，以减少DFU相关的下肢截肢，2）分子生物标志物c-myc和2-连环蛋白与糖尿病足溃疡愈合的相关性;和3）DFU愈合率与情绪应激标志物的相关性，例如增加的血液皮质醇水平和行为应激反应。候选人目前的研究将医学生，博士后研究员和初级教师纳入随机多中心试验的各个方面。全国16个参与糖尿病足溃疡中心是大学附属医院，社区医疗中心，内城医院中心，退伍军人管理局医院或军事医疗中心。学员将学习如何测试使用OWEMR与临床决策支持的有效性，作为减少DFU导致的下肢截肢的干预工具。将随机分配研究中心，以实施OWEMR和临床决策支持，作为干预与标准治疗的对比。所有参与的医疗中心都有大型门诊糖尿病足护理诊所，治疗广泛的人群基础，包括大量的种族和少数民族以及老年人，这将允许对这些队列的治疗结果进行子集分析。这项研究的完成将产生一个新的全面的糖尿病足溃疡数据库的临床信息，可用于确定与愈合结果相关的因素。这项大型临床研究提供了一个独特的机会，以指导博士后研究员和初级教师在POR进行了“真实的生活”的治疗设置对一个广泛的严重和复杂的医疗问题。这个导师计划在纽约大学医学院有以下特点：1）所有临床试验使用相同的综合糖尿病数据库，2）内部和外部导师专门致力于糖尿病足溃疡研究，3）新的临床试验正在开发中，包括使用骨髓源性干细胞治疗糖尿病足溃疡，4）纽约大学内有多中心研究，包括一家大型三级保健医院（Tisch），一家退伍军人管理医院（曼哈顿弗吉尼亚州），一家整形外科医院（关节病医院）和一家内城医院（贝尔维尤）;和5）临床和转化科学研究所是NIH-资助并提供临床研究基础设施，以及为学员提供攻读临床研究理学硕士学位的机会。