New funding program tests two innovative health technologies in diabetic care for adoption into Alberta's health system

Oct. 24, 2016

Kristin Hubert (left) and Marlene Varga (right) photo credit: Kristin Hubert
Kristin Hubert (left) and Marlene Varga (standing) photo credit: Kristin Hubert

Mention “diabetes” and most people think of restricted diets. But for many diabetics, among them Kirstin Hubert, daily insulin injections to regulate blood sugar levels are only one of the challenges of dealing with the chronic disease.

Hubert, 38, who was diagnosed with Type 1 diabetes when she was 11 years old, has gastric neuropathy, peripheral neuropathy in her hands and feet, and retinopathy that has required her to have cataract surgery on both eyes.

Neuropathy numbs and/or weakens nerves, making it difficult and sometimes impossible to feel the affected area.

The most serious and debilitating issue for Hubert has been foot ulcers, which are a direct result of the neuropathy. Her foot problems began in April 2006 when she used a home foot spa for a pedicure. She had enough feeling in her hands to test the water when it came out of the tap, but she didn’t test it again before soaking her feet.

After a few minutes she noticed what looked like a band-aid in the water, which was odd because she hadn’t been wearing a band-aid. When she took her feet out of the water, she discovered that the “band-aid” was skin: the water was so hot, the skin was melting off her feet, leading to third-degree water burns. Because of the neuropathy, she couldn’t feel a thing.

Foot ulcers affect an estimated 15 to 25 percent of people with diabetes. For some, amputation is the eventual solution. Between 2011 and 2012, one-third of amputations in Alberta were performed on people with a diabetic foot wound.

In March 2016, nearly 10 years after Hubert first damaged her feet, she nearly found herself part of that statistic when her doctor said that she was a candidate for a double below-the-knee amputation. Hubert checked herself into Edmonton’s Grey Nuns Hospital and resigned herself to being an invalid for the rest of her life.

That’s when her luck began to change. Marlene Varga, the wound nurse assigned to care for Hubert, was using a new kind of silver bandage, the Exsalt™ wound dressing, made by Edmonton’s Exciton Technologies Inc.

Exsalt™ contains less silver than other silver bandages, making it safer, less painful, and less expensive to manufacture. Another advantage it has over bandages with higher silver content is that it won’t discolour the skin.

Hubert has vivid memories of her skin turning black from her feet to her knees because of the silver bandages that nurses used during her first extended hospital stay in 2006. “It’s quite upsetting to see your legs like that,” she recalls. “You kind of feel like you’re going to lose your legs.”

If Hubert had a choice, she’d use Exsalt™ bandages exclusively, but they’re not widely available.

Alberta Innovates (formally Alberta Innovates – Health Solutions)wants to change that. Through its new funding program, Accelerating Innovation Into Care (AICE), Alberta Innovates (AI) is working with several partners, including Alberta Health Services’ Strategic Clinical Networks (SCNs) to pilot new health technologies from start-up companies in Alberta. The first two projects in the funding program supported the Diabetes, Obesity, and Nutrition SCN to pilot the Exsalt™ wound dressing and another Alberta-made product called the SurroSense Rx®, a pressure-sensing shoe insert designed and manufactured by Calgary’s Orpyx Medical Technologies Inc.

If the products are successful in the SCN setting, they could be adopted for use throughout the province, improving the lives of the many Albertans with diabetic foot disease.

The bandages have already dramatically improved Hubert’s life. For the first time in more than 10 years, her feet are nearly healed. But she also knows that the ulcers may come back because once you have diabetic foot disease, it never completely goes away.

MarleneVarga applying bandages to Kirstin Hubert
MarleneVarga applying bandages to Kirstin Hubert

Even something as seemingly benign as a pebble in one of her shoes can wreak havoc on Hubert’s feet. Because of the neuropathy, she doesn’t feel the pain that should signal her to remove the shoe and shake out the offending object.

That’s where the SurroSense Rx® comes in. It is equipped with sensors that communicate through a smartwatch that alerts the user when there has been too much pressure for too long on the bottom of the foot.

Helping patients by introducing innovative products into the health care system is one of AICE’s primary goals, says Reg Joseph, the AI vice president in charge of the program. “What we really envision, if we dream large, is that our health care system becomes a system that tests innovative technologies, and companies from other jurisdictions will come here. That benefits Alberta patients and the economy.”

If the AICE partnership with the SCN works as Joseph hopes, these solutions will soon be available throughout the province, improving the quality of life of Albertans suffering from diabetic foot disease.

With support from Alberta Innovates (formally Alberta Innovates – Technology Futures) nanoWorks program, Exciton partnered with the National Institute for Nanotechnology (NINT) for research and technical expertise to help expand the Edmonton-based company’s core technology platform: Ag Oxysalts™.

More about Exsalt bandages

Exsalt™ bandages are similar to band-aids, but unlike a standard band-aid, the pad part is coated with a unique silver compound, silver oxysalts, also known as silver nitrate.

Silver has long been known for its healing properties. The ancient Romans used it to control infections. Hippocrates used it to heal wounds and recommended it as a treatment for ulcers. Phoenicians used to put silver coins in water vessels to keep their water clean.

Until it was pushed aside by penicillin and antibiotics, silver was widely used for medical treatment. Now, with rising concerns about antibiotic resistance, it is finding its way back into health care use.

“Bacteria haven’t come up with a way to resist silver,” says Exciton founder Rod Precht. “It’s really encouraging for at least a topical interaction that when we are running out of options for antibiotics, silver is still working.”

Precht has significant experience with silver bandages: in the 1990s, he was part of the team at Sherritt-Westaim in Fort Saskatchewan that developed one of world’s best-selling silver bandages, Acticoat. Acticoat has since been bought by the European company Smith and Nephew.

To develop Exsalt™ ’s unique formula, Precht turned to Stojan Djokic, a chemical engineering professor at the University of Alberta.

Silver is only effective at killing bacteria if it is missing electrons. The more electrons that are missing, the better it works. Most silver bandages are missing one electron. Djokic engineered a form of silver that is missing up to three, making it highly reactive, and therefore capable of killing bacteria more quickly and at a lower concentration than more standard silver bandages.

Because the unique compound contains less silver, it’s also less expensive to manufacture. In fact, Precht says, in many markets, Exsalt™ costs about half of what other silver products do.

But cost is only one of Exsalt™ ’s advantages. Because it releases a lower concentration of silver, the dose is safer, less painful, and doesn’t discolour skin.

AICE is testing Exsalt™ as a therapeutic device, but medical staff and patients have reported that the product has healing properties, which doesn’t surprise Precht.

“We’ve seen this in the past, where active forms of silver are actually therapeutic, not just passive,” he says.

Exsalt™ is used in a number of burn centres in the United States. In the United Kingdom, it’s used for chronic wound care. It’s been approved for use in Korea, and evaluations are ongoing in China.

“We have what I feel to be a much better mousetrap, a better product, which we can offer at a much lower price,” Precht says. “We have something very effective that saves the system money, and upon further evaluation you’ll see the true cost of effectiveness, which is to reduce the time needed to heal chronic wounds, which is a huge burden on the system.”

More about SurroSense Rx® insoles

Calgary physician/entrepreneur Dr. Breanne Everett came up with the idea for the SurroSense Rx® early in her plastic surgery residency, when she saw patients whose diabetic foot wounds required surgery.

In 2010 she started a company, Orpyx Medical Technologies Inc., in Calgary, to develop the product. In 2011, she took a leave from her residency to earn an executive MBA and build Orpyx.

The SurroSense Rx® is just over half a millimetre thick—equivalent to a pile of about five sheets of paper. It is equipped with sensors that communicate through a smartwatch. The smartwatch is similar to an activity tracker. However, rather than counting steps, the system alerts the patient when there has been too much pressure for too long on the bottom of the foot, so that the patient can take action before damage occurs.

“About two-thirds of people with diabetes lose feeling in their feet, and they don’t know when they are doing damage,” Everett says. “They lack the normal pain perception. The idea was to create a technology that would sense what the foot cannot sense itself.”

The SurroSense Rx® has undergone clinical trials in the United States and is in the middle of a trial in England. Results to date have been better than expected: the company’s goal was a 30 percent reduction in foot ulcers. So far, the rate is closer to 83 percent.

Everett is particularly excited about the opportunities presented through the AICE program.

“I’m hoping to see those same outcomes in our own backyard in our upcoming collaboration with the SCN,” she says. “This is taking the device into a real-world scenario. We’re incorporating it into this care pathway, and seeing if we’re able to make a difference.”

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Watch this CTV Edmonton story to learn how Kristin Hubert almost had both feet amputated before a new kind of silver bandage, made by Edmonton’s Exciton Technologies Inc. saved her from that fate.

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