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.
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.
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