Lower Extremity Review
Six research institutions are launching the first-ever multicenter network to study diabetic foot ulcers (DFUs), which are the leading cause of lower-limb amputations in the United States. The Diabetic Foot Consortium (DFC) aims to lay the foundation for a clinical trial network to test how to improve diabetic wound healing and prevent the risk of infections and potential amputations. The DFC is supported by the National Institutes of Health’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
The first studies will focus on finding biomarkers in people with DFUs that can guide treatment and predict how the ulcer will heal and the likelihood of recurrence. For example, the first study, led by the Indiana University (IU) School of Medicine, will test whether body fluid leaking through the skin on a newly healed ulcer can predict how likely an ulcer might recur. A second study, led by the University of Miami (UM) Miller School of Medicine, will test whether the presence of or a change in specific cellular proteins in tissue samples from an ulcer can predict the likelihood of healing in the next 12 weeks.
Each clinical research site in the DFC will recruit up to 70 participants per study who are undergoing DFU treatment or follow-up care. Each biomarker will be tested in its own study within the larger network. Researchers will collect various measurements, biological samples, and other data over 2 years. The DFC will also build a roadmap and framework that will provide an opportunity for researchers to follow up on interesting leads or pursue new studies.
Other participating centers are the University of Michigan (UMich) at Ann Arbor; the University of California, San Francisco; Stanford University; and the University of Pittsburgh. UMich also serves as the data coordinating center for the study. Biomarker analysis will be conducted by IU and UM.
For more information about the Diabetic Foot Consortium, visit diabeticfootconsortium.org.