Diabetes is a common, complex, and costly disease affecting 9.4% (30.3 millions) of Americans. It remains the 7th leading cause of death in the United States, contributing to over 250,000 deaths annually. Diabetic foot ulcers (DFU) are the most frequently recognized complication in diabetics with an incidence of 6% in the diabetic global population, 6% among Medicare diabetic beneficiaries, 5% among diabetic U.S. veterans and a lifetime incidence of foot ulcers between 19% and 34% in diabetics. The natural history of a diabetes-related foot ulcer is devastating. More than half of ulcers become infected and approximately 20% of moderate or severe diabetic foot infections lead to amputation. Mortality after diabetes-related amputations is greater than 70% at 5 years for all patients with diabetes, which is 2.5 times higher than in diabetic patients without a foot ulcer. This proposal is designed to establish a clinical research unit (CRU) at the University of Pittsburgh Medical Center that integrates high quality care delivery seamlessly with outstanding clinical research. The CRU will then be a participating site in the NIH consortium studying biomarkers for diabetic foot ulcer healing. Our central hypothesis is that we can address the major challenges of diabetic foot ulcer clinical research through the seamless integration of wound center clinical operations with research operations.
Our specific aims are:
Aim 1 : Establish a unified recruiting and retention system integrated with the clinical operations of our wound care service line, and linked to our EPIC scheduling system and electronic medical record (EMR).
Aim 2 : Establish integrated research quality systems, linked to highly standardized clinical pathways, and supported by a wound Informatics and Data Core connecting our 8 wound care centers. By achieving these aims, we will have a high rate of enrollment of research subjects, collect useful biomarker data, and be a valuable contributing member of the NIH research consortium.
Diabetic foot ulcers are a complication of diabetes incurring significant suffering, risk of amputation, and tremendous healthcare costs. This proposal establishes a high-quality clinical research unit that will be part of the consortium for the study of biomarkers in diabetic foot ulcers. An understanding of biomarkers that can correlate with the status of wound healing, guide treatment, and predict outcomes will help physicians to more effectively treat diabetic foot ulcers and prevent amputation.
