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

描述（由申请人提供）：候选人研究项目的长期目标是减少由慢性无法愈合的糖尿病足溃疡（DFUs）引起的下肢截肢。这个K24职业生涯中期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，以便候选人可以将30%的精力投入到他的博士后研究员指导计划中，除了医学生和初级教师之外。这项工作都是在纽约大学医学院的海伦和马丁·基梅尔伤口愈合部门进行的，该部门对糖尿病患者导向研究（POR）很感兴趣。候选人的临床糖尿病研究项目，自2002年以来由NIDDK资助，专注于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）的临床决策支持，作为一种医学信息干预工具，以减少肢体损失。两项当前R01拨款和一项RC1拨款资助研究，以制定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)使用OWEMR作为干预工具以及当前的护理标准，以减少DFU相关的下肢截肢；2)分子生物标志物c-myc和2-catenin与糖尿病足溃疡愈合的相关性；3) DFU愈合率与情绪应激指标的相关性，如血皮质醇水平升高和行为应激反应。候选人目前的研究包括医学生、博士后研究员和初级教员参与随机多中心试验的各个方面。全国16个参与的糖尿病足溃疡中心包括大学附属医院、社区医疗中心、内城医院中心、退伍军人管理局医院或军事保健中心。学员将学习如何测试在临床决策支持下使用OWEMR的有效性，作为减少DFUs导致的下肢截肢的干预工具。研究地点将被随机分配，以实施OWEMR和临床决策支持作为干预措施与标准护理。所有参与的医疗中心都有大型的糖尿病足部门诊诊所，治疗广泛的人群基础，包括大量的种族和少数民族和老年人，这将允许对这些队列的治疗结果进行亚组分析。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，指导博士后研究员和初级教师在“现实生活”中对广泛的严重和复杂的医学问题进行治疗。纽约大学医学院的导师项目有以下特点：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溃疡，4)纽约大学内有多地点的研究，包括大型三级护理医院（Tisch），退伍军人管理医院（曼哈顿VA），骨科医院（关节疾病医院），市内医院（贝尔维尤）；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研究硕士学位的机会外，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. PUBLIC HEALTH RELEVANCE: The candidate proposes to develop a structured mentorship program to train new clinical investigators in patient-oriented diabetes research. The focus is on postdoctoral fellows, who are typically surgery residents taking two years to study clinical diabetes research. In addition, the candidate will mentor medical students and junior faculty. The mentees will receive focused attention from the PI and his collaborators; training will be in diverse areas of clinical diabetes research. The research will include three ongoing clinical diabetic foot ulcers trials, supported by two R01 grants and one RC1 grant, which include: 1) a 16-center randomized study to determine if use of clinical decision support decreases amputation rate, 2) determination if molecular markers correlate to healing, and 3) roles of stress on healing rates as determined by serum and pathological markers. The mentees will be trained in database design and management, ethics, and clinical trial design. For example recent mentees have designed a phase I/II clinical trial using bone marrow derived stem cells to accelerate healing. The PI will have 30% time to train fellows, students and junior faculty in POR conducted in a "real life" treatment setting on a widespread serious and complex medical problem in clinical diabetes research.