The collaboration between engineering and physical therapy faculty has produced a prototype that targets nonhealing diabetic foot ulcers.
A recently secured grant from the N.C. Biotechnology Center will provide vital support to an Elon University team working to develop a therapeutic boot to help heal diabetic foot ulcers.
The innovative boot has the potential to help people who are suffering from chronic nonhealing foot ulcers avoid amputation. The boot is designed to increase blood flow to the extremities, a key step toward healing these wounds that can reduce the likelihood of a life-changing amputation.
The project is a collaboration between Daryl Lawson, associate professor of physical therapy education, and Chris Arena, assistant professor of engineering, who have worked to design a boot that employs heat and electrical stimulation to increase blood flow.
“Twenty percent of cases involving diabetic foot ulcers end up in amputation,” said Lawson, who has been research potential therapies for more than a decade. “Not only is that difficult for the patient, but it’s very expensive for the health care system. The amount of money spent on this is enormous, with big impacts both economically and in quality of life.”
The team that also includes Ashley Wenz ’18 has already developed a prototype thanks in part to Elon’s Maker Hub. The $95,500 grant from the N.C. Biotechnology Center will help cover the cost of additional equipment needed to advance the prototype as well as tap into the expertise needed to navigate the Food & Drug Administration approval and patent processes and then commercialize the boot once it gets cleared for the marketplace.
“All of those things influence the experiments you’re doing early on, so it’s good to look at the big picture,” Arena said.
The development of the boot follows years of research by Lawson focused on examining the effectiveness of using electrical stimulation and heat to help promote healing of these chronic wounds. Lawson connected with Arena after learning about his earlier research on the use of electrical stimulation to combat cancer cells, with both realizing that the project would be a natural fit.
“Both of us in different departments working together to create something in both of our fields is pretty exciting and really goes with our studies and our scholarship,” Lawson said. “We’ve really needed the combination of expertise in engineering and physical therapy to develop this.”
Having establish the therapeutic effects of heat and electrical stimulation, the challenge has been in developing a device that could be used by a patient in their home rather than having to visit a clinic regularly. The end goal is to develop a boot that would allow people to be treated in their homes while incorporating health monitoring capabilities that could send results back to a clinician.
Wenz played a leading role in crafting the prototype for the boot in the Maker Hub during the summer of 2016 as part of Elon’s Summer Undergraduate Research Experiences. “We had a few bumps in the road, but that was to be expected,” Wenz said. “We were just testing and trying things out to see what would work. We didn’t know what materials we would be using or what we wanted it to look like.”
The development of the prototype and the collection of data about how it delivers therapy were key to landing the N.C. Biotechnology Center grant, Lawson and Arena said. “The hands-on experience going from the classroom to the lab, and then working with a grant and possibly moving into the clinic is an engaging experience for an undergraduate,” Lawson said. “I think what she’s doing with data collection is pretty amazing for an undergraduate.”
Lawson said the project is approaching the patent stage, with the research focusing now on fine-tuning the boot to determine the most effective and efficient way to deliver the therapies. The goal is to get the boot to the point that it can be put into the field for home use with 10 people with diabetic foot ulcers to collect data that will be used to make the case for FDA approval.
Securing a patent for the technology will pave the way to turn to investors to help fund the project as it moves toward FDA approval, with $500,000 to $1 million needed to develop a device built under design control that can be submitted to the FDA.
“It’s been so unique to work on this in the lab, and see how quickly we can get it to patients,” Arena said.