Percutaneous Treatment of Claudication: The Role of Diabetes and Inflammation

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DESCRIPTION (provided by applicant): Diabetes (DM) and peripheral artery disease (PAD) are rapidly growing health concerns among Americans. In particular, intermittent claudicatiori (IC) affects walking function, general quality of life (QOL), and can herald worsening ischemia. The use of arterial angioplasty and stenting to treat lower extremity arterial occlusive disease has increased recently. However, clinical outcomes have been mixed and their impact on patient QOL difficult to measure, especially for patients with DM who may have additional biological and functional obstacles to treatment success. Louis Nguyen, MD, MBA, is Instructor of Surgery in the Division of Vascular & Endovascular Surgery and Investigator in the Center for Surgery and Public Health at Brigham & Women's Hospital (BWH), a teaching affiliate of Harvard Medical School. This proposal details a plan to develop Dr. Nguyen into an independent clinical researcher. Because of his unique training and experience in surgery and health services research, Dr. Nguyen intends to study problems in vascular surgery by using a combination of institutionally-based clinical studies with nationally collected databases. The plan proposed in this grant will capitalize on the educational, research, and career development resources of several Harvard University institutions. Drs. Michael Conte (Vascular Surgery), John Ayanian (Medicine and Harvard School of Public Health [HSPH]), and Mark Creager (Cardiovascular Medicine) will comprise the Advisory Committee. Drs. Allison Goldfine (Joslin Diabetes Center) and Myriam Hunink (HSPH) will serve as consultants. All five are internationally recognized clinician-researchers in their fields. The proposed prospective observational cohort study will examine the effects of DM, insulin resistance, and inflammation on outcomes of infrainguinal percutaneous peripheral interventions for IC. The first aim examines hemodynamic outcomes using arterial duplex. The second aim examines functional outcomes using treadmill walking performance and QOL surveys. The third aim combines these findings to examine larger treatment implications with a cost analysis and CMS database analysis specific to the care of DM patients. It is anticipated that this research will contribute to the better clinical and economic understanding of IC treatment outcomes for DM patients with PAD risk factors. (End of Abstract)