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

描述(由申请者提供)：候选人研究计划的长期目标是减少因慢性不可愈合的糖尿病足溃疡(DFU)而导致的下肢截肢。K24职业中期研究员奖的目标是提供额外的时间，避免临床和行政责任，以便候选人可以将30%的精力投入到他的博士后导师计划中，除了医学生和初级教师之外。这项工作全部在纽约大学医学院创伤愈合海伦和马丁·基梅尔分部进行，该分部对糖尿病患者导向研究(POR)感兴趣。这位候选人的糖尿病临床研究项目自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肢体丧失的研究。目前的研究重点是促进以患者为中心的在线创伤电子病历(OWEMR)的使用，并提供临床决策支持，作为一种医疗信息干预工具，以减少肢体丧失。目前的两笔R01赠款和一笔RC1赠款用于研究，以开发以患者为中心的循证治疗策略，解决DFU治疗的三个独立但相关的方面：1)将OWEMR用作干预工具，以及当前的护理标准，以减少与DFU相关的下肢截肢；2)分子生物标记物c-myc和2-catenin与糖尿病足部溃疡愈合的相关性；以及3)DFU愈合率与情绪应激指标的相关性，例如血液皮质醇水平升高和行为应激反应。这位候选人目前的研究将医学生、博士后研究员和初级教员纳入了随机多中心试验的所有方面。全国参与的16个糖尿病足溃疡中心要么是大学附属医院，要么是社区医疗中心，要么是市中心医院中心，要么是退伍军人管理局医院，要么是军队医疗保健中心。受训者将学习如何测试使用OWEMR与临床决策支持的有效性，作为一种干预工具，以减少因DFU导致的下肢截肢。研究地点将随机实施OWEMR和临床决策支持，作为一种干预措施，而不是标准护理。所有参与的医疗中心都有大型的糖尿病足门诊护理诊所，这些诊所治疗的人群基础广泛，有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临床信息数据库，可用于识别与治愈结果相关的因素。这项大规模的临床研究提供了一个独特的机会来指导在POR中进行的博士后研究员和初级教员，他们在一个普遍严重和复杂的医疗问题上进行了“现实生活”的治疗。该导师计划在纽约大学医学院具有以下特点：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部溃疡的研究，3)新的临床试验正在开发中，包括使用骨髓来源的干细胞治疗糖尿病足部溃疡，4)纽约大学内部有多点研究，包括大型三级保健医院(Tisch)、退伍军人管理医院(VA)、骨科医院(关节疾病医院)和市中心医院(Bellevue)；5)临床和转化科学研究所由美国国立卫生研究院资助，除了为学员提供攻读临床调查理学硕士学位的机会外，还提供临床研究基础设施。

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.