Western researchers develop a special boot to save limbs and lives

KALAMAZOO, Mich.—Diabetes is a national concern, affecting more than one in 10 Americans. Among the many health challenges it causes, the disease can put patients at risk for dangerous foot ulcers and lower limb amputations. But innovative research at Western Michigan University could be a game-changer, accelerating healing and saving limbs and lives.

"When people with diabetes develop a wound or ulcer on the bottom of their foot, it may become chronic and they are slow to heal," says Dr. Daryl Lawson, associate professor of physical therapy, also noting access to a specialized wound care center is a barrier for many people living in remote and rural areas. "So I thought, if we could develop something where we can monitor and treat people with diabetes and chronic, non-healing ulcers, we can prevent amputations and heal the wounds."

Lawson saw the impact of amputations firsthand as a practicing physical therapist for many years. An amputation can medically stabilize a person with diabetes and a non-healing wound, especially if it is infected. But it comes with consequences.

"If you take the leg, you'll take away the function for the rest of their life," says Lawson, giving the example of a carpenter losing his identity after an amputation because he can't do what he loves anymore. "The more I was involved, the more I saw that we can medically stabilize a lot of people, but it really changes their whole life—both physically and mentally—when you take that reason for being away."

A dream decades in the making is now nearing the finish line for Lawson, who worked with Dr. Christopher Arena, associate professor of biomedical engineering at Virginia Tech, to invent SenLore: A boot that not only offloads pressure on diabetic foot ulcers but also delivers a combination of heat and electrical stimulation to increase blood flow and dramatically speed up the healing process. The results, so far, are remarkable; initial research at Western shows SenLore's combination of heat and electrical stimulation increased blood perfusion at the foot in people with diabetes more than 186%.

"The purpose was to combine both of those elements to treat people at home or an assisted nursing facility and be able to monitor people to make sure they never get to the point of amputation," says Lawson. Through the support of the Western's Biosciences Research and Commercialization Center and entrepreneurial connections, the duo helped launch a company—Adlore, Inc.—to take their invention from concept to viable product.

The SenLore team is working with Tekna, a product development company founded by Western alumnus Kris and Claire Eager, and SafeSense Technologies, a sensor development company co-founded by Western alumnus Dr. Binu Narakathu, to produce the first-generation boot. A product like this, says Lawson, could be a transformative—especially for seniors.

"It can be a challenge for seniors to learn and function using a prosthetic. Simple things like taking care of their grandchildren may be the key thing they love to do in their life, and if they can't do that, it's devastating. So if you can prevent an amputation and heal the wound, a person can return to their normal functional activity. And that's pretty gratifying."

Dream Team

After arriving at Western in 2018, Lawson was introduced to a kindred spirit who could take the project to the next level: Dr. Massood Atashbar, a presidential innovation professor and director of the Center for Advanced Smart Sensors and Structures (CASSS). Atashbar's work includes developing smart bandages to treat non-healing wounds through targeted oxygen delivery—an innovation hailed as a world-changer by Smithsonian Magazine.

"I have a passion for creating something that may have a positive impact on someone's life," Atashbar says, expressing his excitement to work with Lawson on the project.

"Any serious project that can have an impact needs to be interdisciplinary, being involved with different disciplines to learn what problems we have and what we can do together," he says. "I enjoy collaboration. I enjoy interdisciplinary forms of science and anything biomedical related, and my students are learning a lot, too."

Atashbar and his graduate students are engineering technology to monitor blood flow and other cardiovascular metrics and integrate the data with a smartphone application. It involves creating flexible, screen-printed sensors and electrodes—a novel idea in itself—that will be integrated in the boot's insole.

"My work at Western has had an incredible impact on knowledge and skills related to my work, not only in technical matters but also in collaborative and organizational ones," says Jose Rodriguez-Labra, who is pursuing a master's in electrical engineering. He is developing algorithms that extract the cardiovascular metrics from the Photoplethysmography (PPG) sensors. "It makes my work that much more meaningful when I know I am part of research that will help drive medicine, therapy and diagnosis forward."

Doctoral student Simin Masihi's dissertation focuses on developing wearable and health-monitoring sensors, so when she heard about the SenLore project she knew she could help. She's now exploring how to expand the boot's capabilities by designing a resonant sensor for low-cost, contact-free monitoring of the wound to measure tissue changes without interrupting the wound's healing process.

"I am very honored to be involved in developing systems and sensors that can improve people's quality of life," she says.

This is just the latest in a series of projects Masihi and students in CASSS have participated in related to innovations in health care, such as microplasma-based sterilization, a medical system to track cardio pulmonary diseases and a pressure-sensitive cap to enhance protection of athletes.

"We've been attempting to use these sensors and software to solve the issues people face daily and bring them to market," says Masihi.

"As an engineer, it is extremely important for me to be part of a project that will benefit people who are afflicted with a disease," adds Masoud Panahi, an electrical engineering master's student who has also been heavily involved in CASSS during his time at Western. He's building an Android application for communicating with the sensors. When finished, the app will connect to the boot through Wi-Fi, alerting clinicians and patients to any changes in metrics immediately.

Cutting-Edge Innovation

The SenLore technology is unlike anything available on the market right now.

"In the long run, a patient can be home;they don't need to go to see a doctor or physical therapist to constantly update their progress," Atashbar says. "If we have feedback in terms of the level of oxygen that is being generated, the doctor can create a new dose and it can be applied or downloaded on the cellphone of the patient and at their convenience."

The hope this invention could provide for millions of Americans is not lost on research assistant Tony Nelson. Just last year his uncle lost his leg from the knee down because of complications related to diabetes.

"He had a wound around his ankle and it just wouldn't heal and got infected. This product could have potentially increased the blood flow around his wound, resulting in the wound healing and not getting infected," says Nelson, who earned his master's degree in electrical engineering from Western in 2019 and will begin work on a doctoral degree in the fall. "My favorite thing about engineering is to think of how many people these products could help."

Lawson and his physical therapy students have completed a pilot project confirming the boot's healing properties. The next phase of the project will involve clinical trials to collect more data from patients with the ultimate goal of submitting successful results to the FDA for approval and generating funding to move into the commercialization phase.

If all goes as planned, SenLore could be available to diabetes patients in 2023. While the technology currently focuses on foot ulcers, Lawson says there is tremendous potential to expand its use in the future.

"We chose foot ulcers because they are such an unmet medical need right now. But if you step back, this is really about tissue healing," Lawson says, considering the possibility of applying the technology to other pressure ulcers or even muscle tears that have a hard time healing.

The project also has students thinking of even more opportunities to use their engineering skills for life-changing innovations.

"The work that we are doing and the systems we've built have given us lots of ideas for other medical research projects," Rodriguez-Labra says. "There is a lot of potential in what we're doing both in the impact we can have and in other possible projects."

For more WMU news, arts and events, visit WMU News online.

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