David J. Margolis, M.D. MSCE is currently Associate Professor of Dermatology, an Associate Professor of Epidemiology in the Department of Biostatistics and Epidemiology, and Senior Scholar (core faculty member) in the Center for Clinical Epidemiology and Biostatistics of the University of Pennsylvania. He is a patient-oriented researcher with a track record of research. His research has been focused on the prevention and treatment of chronic wounds. He has applied a variety of epidemlologic tools and patient-oriented research methods to address research issues. His immediate and long-term career goals center on his desire and intention to continue to evolve and mature as a patient-oriented researcher, teacher, and mentor. Resources available to him, on and around the Penn campus, include biostatistical support, data management support, and research/clinical laboratory services. The proposed patient-oriented NAIMS-funded research project is in its first of five years. Most patients with chronic wounds of the lower extremity fail to heal in a reasonable period of time. In fact, despite considerable advances in elucidating the molecular basis of wound repair, attempts at developing new therapies have been disappointing. Current methods of applying cytokines to chronic wounds are inadequate. The PI hypothesize that a growth factor associated with wound healing PDGF-BB, when produced in large quantities within the wound bed due to adenovirus-mediated gene overexpression by the cells of the wound bed, will dramatically enhance wound healing. This study will use a gene therapy approach, adenovirus-Ad5 and the PDGF-B gene, to insure delivery of a cytokine growth factor to a non-healing wound.
The aim of the research study is to assess local and systemic toxicity, and the biologic feasibility of using the maximum tolerated dose of H5.020CMVPDGF-B associated with in vivo PDGF-BB gene transduction via an intra-ulcer injection of H5.020CMVPDGF-B in patients with chronic venous leg ulcers. This study is a collaborative effort between investigators from the University of Pennsylvania Medical Center (Dermatology and Institute for Human Gene Therapy), the Wistar Institute, and the Children's Hospital of Philadelphia.

Agency
National Institute of Health (NIH)
Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Type
Midcareer Investigator Award in Patient-Oriented Research (K24)
Project #
5K24AR002212-02
Application #
6511748
Study Section
Special Emphasis Panel (ZAR1-JRL-C (O1))
Program Officer
Moshell, Alan N
Project Start
2001-05-01
Project End
2006-02-28
Budget Start
2002-03-01
Budget End
2003-02-28
Support Year
2
Fiscal Year
2002
Total Cost
$135,744
Indirect Cost
Name
University of Pennsylvania
Department
Dermatology
Type
Schools of Medicine
DUNS #
042250712
City
Philadelphia
State
PA
Country
United States
Zip Code
19104
Sargen, Michael R; Hoffstad, Ole; Margolis, David J (2013) Geographic variation in Medicare spending and mortality for diabetic patients with foot ulcers and amputations. J Diabetes Complications 27:128-33
Margolis, David J; Gupta, Jayanta; Thom, Stephen R et al. (2013) Diabetes, lower extremity amputation, loss of protective sensation, and neuronal nitric oxide synthase associated protein in the chronic renal insufficiency cohort study. Wound Repair Regen 21:17-24
Sargen, Michael R; Hoffstad, Ole J; Wiebe, Douglas J et al. (2012) Geographic variation in pharmacotherapy decisions for U.S. Medicare enrollees with diabetes. J Diabetes Complications 26:301-7
Thom, Stephen R; Milovanova, Tatyana N; Yang, Ming et al. (2011) Vasculogenic stem cell mobilization and wound recruitment in diabetic patients: increased cell number and intracellular regulatory protein content associated with hyperbaric oxygen therapy. Wound Repair Regen 19:149-61
Margolis, David J; Hoffstad, Ole; Nafash, Jeffrey et al. (2011) Location, location, location: geographic clustering of lower-extremity amputation among Medicare beneficiaries with diabetes. Diabetes Care 34:2363-7
Margolis, David J; Hoffstad, Ole; Thom, Stephen et al. (2010) The differential effect of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers with respect to foot ulcer and limb amputation in those with diabetes. Wound Repair Regen 18:445-51
Margolis, David J; Morris, Lee M; Papadopoulos, Maryte et al. (2009) Phase I study of H5.020CMV.PDGF-beta to treat venous leg ulcer disease. Mol Ther 17:1822-9
Kurd, Shanu K; Hoffstad, Ole J; Bilker, Warren B et al. (2009) Evaluation of the use of prognostic information for the care of individuals with venous leg ulcers or diabetic neuropathic foot ulcers. Wound Repair Regen 17:318-25
Margolis, David J; Hoffstad, Ole; Strom, Brian L (2008) Association between serious ischemic cardiac outcomes and medications used to treat diabetes. Pharmacoepidemiol Drug Saf 17:753-9
Margolis, David J; Hofstad, Ole; Feldman, Harold I (2008) Association between renal failure and foot ulcer or lower-extremity amputation in patients with diabetes. Diabetes Care 31:1331-6

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