Press Release – August 5, 2020
Funded by the National Institutes of Health, six U.S. research institutions are launching the first-ever multicenter network to study diabetic foot ulcers, a common and burdensome complication of diabetes
and the leading cause of lower limb amputations in the U.S. 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 amputations among the 27 million American adults with diabetes. The DFC is supported by the NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
“People with diabetic foot ulcers have to manage careful at-home foot care over a long time to avoid infection until the wound heals,” said Dr. Teresa Jones, NIDDK’s project scientist for the consortium. “This consortium will address a major research gap in finding ways to effectively treat diabetic foot ulcers and to prevent the risk of complicated infections and potential amputation.”
Participating clinical research sites
The institutions participating in the Diabetic Foot Consortium are Michigan Medicine in Ann Arbor; University of California, San Francisco; Stanford University, Palo Alto, California; University of Miami Miller School of Medicine; University of Pittsburgh; and Indiana University, Indianapolis. Michigan Medicine also serves as the data coordinating center for the study. Biomarker analysis will be conducted by Indiana University and the University of Miami.
The Michigan Medicine team is led by corresponding principal investigator Rodica Pop-Busui, MD, PhD; Crystal Holmes, DPM, CWS; and Brian Schmidt, DPM, from the Division of Metabolism, Endocrinology & Diabetes in the Department of Internal Medicine.
"Michigan Medicine being selected as one of the six participating institutes is due to our strong team of clinician scientists, diabetes specialists, podiatrists, vascular surgeons, and bioinformaticians with an unparalleled track record of working together in daily patient care and innovative research to save the limbs of people with diabetic foot ulcers and other complications, and improving the life of all patients with diabetes."
- Dr. Brian Schmidt, Assistant Professor
The team's strength and innovative nature can be found in the recently published "Strategies to Reduce Severe Diabetic Foot Infections and Complications During Epidemics (STRIDE)" which describes the algorithm they developed and implemented in one week that effectively risk-stratified and triaged all patients with diabetic foot complications, preventing an increase in hospitalization and amputations, while promoting both social and physical distancing. Implementation of the STRIDE protocol resulted in even lower severe infections and amputations than prior to pandemic.
The first studies will focus on finding biological clues, called biomarkers, in people with diabetic foot ulcers that can guide treatment and predict how the ulcer will heal and the likelihood of an ulcer returning. For example, the first study of the DFC, led by the Indiana University School of Medicine, will test whether body fluid leaking through the skin on a newly healed ulcer can predict how likely an ulcer might return. A second study, led by the University of Miami, 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.
Up to 34% of people with diabetes will develop a foot ulcer in their lifetime, and half of foot ulcers become infected. Each year, about 100,000 Americans with diabetes will lose part of their lower limb because a foot ulcer becomes infected or does not heal.
Each clinical research site in the DFC will recruit up to 70 participants per study who are undergoing foot ulcer 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 two years. In addition, the DFC will build a road map and framework that will provide an opportunity for researchers to follow up interesting leads or pursue new studies.
“Many complicating factors of diabetes interrupt the healing process, making diabetic foot ulcers extremely difficult to treat. Those factors also make studying effective treatments challenging,” said DFC Study Chair Dr. Geoffrey Gurtner, Professor of Surgery at Stanford University.
"These pioneering studies are a remarkable opportunity to identify sensitive and specific biomarkers that can be used as tools to improve how foot ulcers are treated and healed," added Dr. Rodica Pop-Busui, Larry D. Soderquist Professor. "Our goal is for clinicians to be able to say, 'This patient has this biomarker or this constellation of risk factors, and we know exactly what to do to personalize his or her treatment in daily practice'." Dr. Pop-Busui is also the Associate Director of Clinical Research, Mentoring, and Development at the Elizabeth Weiser Caswell Diabetes Institute and Vice Chair of Clinical Research for the Department of Internal Medicine.
Dr. Crystal Holmes, Associate Professor and the Director of the Michigan Medicine Podiatry Clinic, summarized the importance of the multicenter network, stating "The Diabetic Boot Consortium is looking for biomarkers that are predictive of wound healing. If we are able to identify a biomarker - this could be a game changer in terms of treatment and improving outcomes for our patients with diabetic foot ulcers."
For more information about the Diabetic Foot Consortium, please visit diabeticfootconsortium.org.