Saving Superman

On Oct. 10, 2004, Christopher Reeve died from heart failure resulting from an infected pressure ulcer. In what now seems a strangely meaningful parallel, earlier that same year Dr. Vivian Mushahwar began to focus her research on the very condition that would ultimately lead to his death.

It was not the biomedical engineering professor and neuroscientist’s first time wrestling with the problem of how to address pressure ulcers. In 1996 she had come up with an idea to prevent the dangerous condition while doing her PhD. For her candidacy exam, she had to write a grant proposal on something unrelated to her own research. Her work on the use of electrical stimulation to restore movement in people with spinal-cord injury had brought her into contact with many patients who suffered from pressure ulcers, and Mushahwar wondered what would happen if she could get the patients’ muscles to contract periodically using electrical stimulation. “Fidgeting is a natural response to discomfort that develops from sitting or lying down, but someone who does not have sensation or is unable to move, cannot fidget on their own,” explains Mushahwar, recalling the “aha” moment that sparked her idea. “So I wrote that as my candidacy exam. It all started there.”

Fast forward several years to Mushahwar’s arrival at the University of Alberta. “‘The gods of neuroscience’ were here and all of the literature at the time referenced them,” she says of what brought her to Edmonton, referring to emeritus faculty members Drs. Tessa Gordon, Keir Pearson and Richard Stein, and current faculty member Dr. Arthur Prochazka. She was also awarded a fast-track postdoctoral fellowship from the then-Alberta Heritage Foundation for Medical Research, which provided critical funding for her work. After completing her postdoc, she accepted the offer to join the Faculty of Medicine & Dentistry with an adjunct appointment in the Faculty of Rehabilitation Medicine, and took the opportunity because of the environment at the university and the available funding. “That continuum of basic, applied research and patient care was so visible here and I hadn’t seen it anywhere else in North America. It was breathtaking.”

That environment of excellence encouraged her to turn her attention to the issue of pressure ulcers again, where Mushahwar found that the thinking and the literature on the condition had not changed in the intervening eight years since her PhD candidacy exam, and the very serious problem had not been addressed in a clinical sense. Conventional wisdom was that pressure ulcers were a “care issue”, but even with best practices and the most diligent care, patients with reduced mobility were still developing pressure ulcers.

What are pressure ulcers?

There are two types of pressure sores that develop in people with reduced mobility and sensation: those on the surface of the skin, which break through skin, fat or muscle all the way to the bone, and the other, which develops at the interfaces of bone and muscle and is only detected when extensive damage exhibits on the surface of the skin. This second level of pressure ulcer in particular can cause infection, sepsis, organ failure and death. In the United States pressure ulcers kill more than 60,000 people every year, making them one of the 10 leading causes of death.

Mushahwar and her team also found that turning a patient is not as effective for prevention as active contraction of that patient’s muscles, so they came up with a solution encompassing this new thinking on pressure ulcers: Smart-e-Pants™. The close-fitting shorts contain pads that deliver a minor electrical stimulus every 10 minutes to cause muscle contraction.

Phase 1 clinical trials, in which 70 patients used the device for anywhere from one month to 16 months in settings ranging from intensive care to home care, are already complete. Both patients and practitioners found the device very safe and feasible for everyday use, and none of the patients developed pressure ulcers.

The Phase 2, multi-centre clinical trials will determine the innovation’s effectiveness and is on schedule. In the meantime, Mushahwar and her team are addressing the necessary regulatory approvals with Health Canada and the U.S. Food and Drug Administration to start selling the devices. Work is also expected to begin soon to demonstrate the cost-effectiveness of the pants for the health-care system through a partnership between Alberta Innovates – Health Solutions and Alberta Health Services. The upshot? Smart-e-Pants™ are expected to be available for sale in 2015, with the potential to improve, even save, the lives of millions of people around the world.

They will also save billions of dollars in health spending, says Mushahwar, citing the expertise provided in collaboration as one of the reasons why the product commercialization has been possible.

Dr. K. Ming Chan, a professor in the Division of Physical Medicine & Rehabilitation in the Faculty of Medicine & Dentistry, has been working as clinical lead on the co-ordination of the clinical testing in different health-care settings in Edmonton and Calgary for the last five years. “An important next step is to formally evaluate the efficacy of the Smart-e-Pants™ in preventing deep pressure ulcers and to establish the health-care savings that such a treatment would be able to achieve,” he says.

As part of the collaboration encouraged through the Campus Alberta initiative of the Ministry of Innovation and Advanced Education, Mushahwar and her team have been working with Dr. Sean Dukelow, assistant professor in the Division of Physical Medicine & Rehabilitation at the Hotchkiss Brain Institute at the University of Calgary. Dukelow has been the clinical lead for testing Smart-e-Pants™ in Calgary for the last six years and has a wealth of experience with the longstanding challenges of pressure ulcers for those with impaired mobility.

“Once they develop, pressure ulcers are life altering for the patient and are typically difficult to treat,” he says. “Unfortunately, treatment of deeper pressure ulcers can take months or years. Even in our modern health-care system, we still see fatalities as a result of complications from pressure sores. In the time I have spent caring for individuals with pressure sores I have come to realize that the cure, in my opinion, is prevention.

“It is paradoxical that we have cures for many common illnesses, yet still struggle with such a simple and preventable complication of immobility. Pressure ulcers can be frustrating and painful to treat for both the patient and the health-care provider. I look forward to a day when we can eradicate them completely.”

So 10 years after Christopher Reeve’s passing, a device that could have prevented his death and that of many others—and could improve the quality of life for countless patients with reduced mobility—is almost ready for the market. What does that mean to Mushahwar? “It means everything,” she says simply. “I got into bioengineering to use my skills to help people. Making a difference in even one person’s life makes it all worthwhile.”

And that is something that Superman himself would understand.

Christopher Reeve, aka Superman, died of complications related to pressure ulcers. Today, a team led by Faculty of Medicine & Dentistry researcher Dr. Vivian Mushahwar, is close to commercializing a product that would have saved his life, and will save the lives of potentially millions more.

By Janet Harvey

Photography by Aaron Pedersen.