The Diabetic Foot Consortium: The First U.S. TrialSite Network to Study Diabetic Foot Ulcers: A $13B per year Problem

The Diabetic Foot Consortium: The First U.S. TrialSite Network to Study Diabetic Foot Ulcers: A $13B per year Problem

Thanks to money from the National Institutes of Health (NIH), Six U.S. research centers have come together to form 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 United States. Called the Diabetic Foot Consortium (DFC), the TrialSite network seeks to lay the foundation for a clinical trial network to investigate 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).

The TrialSite provides a breakdown of this new trial site network.

What is the fundamental health challenge here?

Up to 34% of people with diabetes will develop a foot ulcer in their lifetime, and half of the 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. 

“For people with diabetes, foot ulcers can be devastating and lead to even more devastating amputation. They affect quality of life and cost the United States up to $13 billion a year in care,” said NIDDK Director Dr. Griffin P. Rodgers. “Finding biological clues from these ulcers to help tailor treatment to the individual will provide much-needed relief and could prevent future diabetic foot injuries.”

What organization is paying for this clinical trial site network?

NIDDK, part of the NIH, via the following NIH grants DK119085DK119083DK119094DK119099DK119100DK119102, and DK122927.

Why was the DFC created?

As reported by Dr. Teresa Jones, NIDDK’s project scientist for the consortium: “This consortium addresses a major research gap in finding ways to effectively treat diabetic foot ulcers and to prevent the risk of complicated infections and potential amputation.”

What does the DFC network focus on first?

The first studies focus on the biological clues, known as biomarkers, in people with diabetic foot ulcers that can guide treatment and better predict how the ulcer will heal and the likelihood of an ulcer returning.

What are DFC’s first studies?

The first study of the DFC will be led by the Indiana University School of Medicine and will test whether body fluid leading through the skin on a newly healed ulcer can predict how likely an ulcer might return.

Another study, led by the University of Miami, will investigate whether or not a chance in specific cellular proteins in tissue samples from an ulcer can predict the likelihood of healing in the next 12 weeks.

What are the study details?

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 roadmap and framework that will provide an opportunity for researchers to follow up interesting leads or pursue new studies. 

What are the DFC’s Participating Sites?

Participating centers are the University of Michigan at 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. The University of Michigan also serves as the data coordinating center for the study. Biomarker analysis will be conducted by Indiana University and the University of Miami.

Call to Action: For more information, visit the Diabetic Foot Consortium website.