To help improve outcomes for patients with diabetic foot ulcers, the clinical and translational research team at the University of Miami Miller School of Medicine’s Department of Dermatology and Cutaneous Surgery received a four-year, $1.7 million grant to become one of six Clinical Research Units (CRU) across the U.S. This team approach to research is part of the National Institute of Diabetes and Digestive and Kidney Diseases’ Diabetic Foot Consortium for future clinical study of selected biomarkers.
Diabetic foot ulcers are a widespread and serious clinical problem with high morbidity and associated mortality.
“Of the 30 million diabetics in the U.S., one in four will have a foot ulcer during their lifetime and one in six of those patients will go on to amputation,” said Robert S. Kirsner, M.D., Ph.D., chair and Harvey Blank Professor in the Department of Dermatology and Cutaneous Surgery and one of the UM-CRU principal investigators. “Diabetes-related amputations are associated with disability, drastic reduction in quality of life, high morbidity and resultant alarming mortality rate of 50 percent over five years.”
The objective of the Diabetic Foot Consortium (DFC) is to establish an organizational framework and infrastructure that will serve as a platform for integrated multidisciplinary experimental clinical and translational research. The UM-CRU will, in conjunction with DFC, develop the research design and study protocol, and establish protocols for participant recruitment and follow-up, data collection, quality control, interim data and safety monitoring, final data analysis and interpretation, and publication of results.
In addition, UM-CRU and DFC will facilitate procurement, storage and shipment of the biomaterials (tissue samples, swabs, wound fluid, blood, serum and/or urine) as a part of the future biomarker studies. It will also establish and maintain a clinical database that will allow overall data analyses of the DFC. Patient recruiting will begin early this year.
“We commend the NIDDK for raising awareness of this devastating complication of diabetes and taking the initiative to form the Diabetic Foot Consortium,” said Marjana Tomic-Canic, Ph.D., professor and director of the Wound Healing and Regenerative Medicine Research Program in the Department of Dermatology and Cutaneous Surgery, who is one of three Miller School principal investigators in the research. “The DFC is comprised of six Clinical Research Units, one of which is the University of Miami. We are very proud that our team was chosen as a CRU. It is a recognition of longstanding clinical and basic science research in wound healing at our department and our institution, and the tradition of excellence and innovation in both wound healing and diabetic research at UM.”
The other Miller School principal investigator is Hadar Lev-Tov, M.D., assistant professor, and team investigators include Leigh Nattkemper Ph.D., research assistant professor, and Anna Nichols, M.D., Ph.D., assistant professor, all from the Department of Dermatology and Cutaneous Surgery.