Researchers to Study Multiple Biomarkers in Diabetic Foot Ulcers

Researchers at the University of Miami Miller School of Medicine recently received notification of two DiaComp (Diabetes Complications) pilot grants from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to study biomarkers in diabetic foot ulcers.

Immunofluorescence staining of a tissue section from a patient with a diabetic foot ulcer. Beta-catenin is shown as green.

“Diabetic foot ulcers are one of the most debilitating complications of diabetes, frequently leading to amputations,” said Marjana Tomic-Canic, Ph.D., professor of dermatology, vice chair of research, and director of the Wound Healing and Regenerative Medicine Research Program in the Department of Dermatology and Cutaneous Surgery, who is the principal investigator in the two studies. “Diabetes-related amputations are associated with disability, drastic reduction in quality of life, high morbidity and an alarming resulting mortality rate of 50 percent over five years. We are very excited to participate in the DiaComp/NIDDK initiative that will, in this pilot phase, select potential biomarkers and implement methodology to support and facilitate the next phase, which will be validation of these biomarkers in a large multi-center clinical trial.”

One study will test cortisol synthesis genes, including CYP11B1 as a potential biomarker associated with clinical outcomes in diabetic foot ulcers. The second study will test c-myc and beta-catenin as potential diagnostic and predictive biomarkers for diabetic foot ulcers.

“Developing molecular tools in clinical practice is a necessary approach in future diagnostics and treatments of patients with diabetic foot ulcers,” said Tomic-Canic. “Such complex studies can only be accomplished with team science approach.”

In addition to Tomic-Canic, the UM research team members will include departmental colleagues Robert S. Kirsner, M.D., Ph.D., Harvey Blank Professor and Chair, and Irena Pastar, Ph.D., research assistant professor, in collaboration with affiliated faculty at the University of Manchester, and additional investigators at the University of Hull and the University of Pennsylvania. Research under the second grant will also be conducted with Kirsner and Pastar, and with collaborators at New York University Winthrop Hospital.

“The first step in the precision medicine approach to treatment is to identify which patients will not heal with standard care so that more advanced biologic therapies can be implemented early, rather than following the ‘wait-and-see’ approach currently used,” said Tomic-Canic.

“We have assembled a multi-disciplinary international team of clinicians and scientists that will develop infrastructure for validating potential biomarkers in the clinical trials. This will have high impact, because in addition to identifying a subset of patients who are not going to heal, it also may indicate potential new avenues for therapeutic intervention. Ideally, one would like to have a diagnostic tool that will identify patients who would most benefit from a particular therapy.”

Tags: biomarkers, cortisol synthesis, diabetic foot ulcers, DiaComp, Irena Pastar, Marjana Tomic-Canic, Miller School of Medicine, NIDDK, Robert Kirsner, University of Miami