Collaborative Clinical Study Tests Impact of Novel Imaging Technology on Diabetic Foot Ulcers

Researchers at the University of Miami Miller School of Medicine, working in collaboration with the inventors of a novel imaging technology at the Florida International University Department of Biomedical Engineering, are conducting a clinical study of a scanner that can see into tissue and monitor real-time physiological activity in diabetic foot ulcers.

Diabetic foot ulcers are one of medicine’s greatest clinical challenges. In the U.S. alone, they afflict 29 million patients at an annual cost of $13 billion. They are the leading cause of lower-limb amputation, and patients who have them experience a 50 percent increase in five-year mortality. The keys to healing diabetic foot ulcers, as with all wounds, are good blood flow and oxygenation, but healing occurs inside the wound, where you can’t see, much less measure, its progress.

“This imaging device has the potential to serve as a tool that can help us predict which wounds are likely to heal on their own and which need therapeutic intervention, as well as which therapies may work better than others,” said Robert S. Kirsner, M.D., Ph.D., the Harvey Blank Professor and chair of the Miller School’s Department of Dermatology and Cutaneous Surgery. “If you can improve the response to therapy, you can both improve patient outcomes and reduce the financial cost to society.”

The Near-Infrared Optical Scanner, or NIROS, was developed by Anuradha Godavarty, Ph.D., associate professor of biomedical engineering, and her team at FIU. It is very small and lightweight — similar to a hand-held device attached to a laptop — and uses hemodynamic imaging to monitor healing and better steer the treatment process than the visual inspection and monitoring of surface granulation most commonly used by clinicians.

“I conducted an initial pilot study at a clinic in India, and the results were very good,” said Godavarty. “Then I worked with two podiatrists who had independent clinics in Miami. What I really needed, however, apart from private clinicians, was a research-oriented team to work with. That’s what I found at UM with Dr. Kirsner.”

Godavarty was introduced to Kirsner by another Miller School researcher, Ernesto A. Pretto, Jr., M.D., M.P.H., professor of clinical anesthesiology. Pretto, who is active in UM’s Technology Transfer program, met Godavarty at a seminar teaching researchers how to apply for Small Business Innovative Research grants.

“Dr. Godavarty was looking for someone who could provide her with patients to study,” said Pretto. “There are many potential applications for her technology, but it seemed best to take a focused approach at the start, so I arranged for her to meet with Dr. Kirsner. When they agreed to work together, I helped prepare the Institutional Review Board application approximately 18 months ago and became a PI in the study.”

The study is ongoing, and the researchers are still recruiting subjects. They have also submitted a joint NIH grant application for additional funding to expand the study into other types of wounds, such as venous leg ulcers. Kirsner estimates that they are a year away from being able to report their findings. Meanwhile, Miller School researchers engaged in procedures as varied as plastic surgery and transplantation have expressed interest in also testing the technology.

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