Walking past the pain

It’s known as the ‘Cinderella disease’, yet one of the great threats of peripheral artery disease (PAD) is losing a lower limb, not merely misplacing a glass slipper.

Indeed, the affliction can be anything but a fairytale,
a fact reinforced to Sunshine Coast nurse Gil Marconi
on a recent return to her homeland of Brazil.

“My best friend’s mother developed a red discolouration on her foot,” says Ms Marconi.

“By the second day that had turned to blistering, by day three that had turned to one of the deepest, fastest-forming wounds I’ve ever seen.

“Within a week she had gone from hobbling around in the family business, thinking her sore foot was just a sign of old age, to developing gangrene, and a quarter of her foot needed to be amputated, including her big toe.

“It’s turned her world, and her family’s world, upside down. She’s going to have to learn to walk again, her spirits are low, and the family’s livelihood is in jeopardy while others take time off to care for her.”

University of the Sunshine Coast researcher Associate Professor Christopher Askew says this is an extreme example of PAD, caused by the build-up of fatty plaques, narrowing and blockages in the arteries of the legs.  This results in a reduction of blood flow, causing leg pain and discomfort.

“Most people experience warning signs over a longer period of time – and a cramp-like pain in the muscles of the legs during walking and other types of activities is the first sign of the condition for most people.”

Yet, if untreated, the consequences can be even worse than leg pain and gangrene, with potentially fatal strokes and heart attacks among the possible outcomes.

“We describe PAD as a literal risk to life and limb,” Dr Askew says.

“Most people are aware of stroke and heart disease in the community, but PAD is like the poor cousin which nobody hears about, which is why we refer to it as the ‘Cinderella disease’.

“Many people only learn about PAD when somebody they know is directly affected by it.“

This is despite the fact studies have shown that people with PAD are at double the risk of suffering a cardiovascular event, like a heart attack or a stroke, even when compared with people who have established heart disease.

“What we’re aiming to do with our current work is to have an impact at an earlier stage, ideally so people can become more active and be less limited by the disease.”

Dr Askew is leading the FootPAD trial, which is testing the benefit of neuromuscular electrical stimulation using a footplate device called Revitive.

The muscle stimulation is intended to promote the growth of new capillaries in the lower limbs and improve blood flow and the delivery of oxygen to the muscles.

Participants in the FootPAD trial use the footplate device for two 30-minute sessions per day.

Although the device can be used while “reading, watching TV, or using a mobile electronic device”, Dr Askew is quick to reinforce that an active lifestyle is also encouraged.

“We are wanting to see if using the device can help people with PAD walk further and be more active on a day-to-day basis,” Dr Askew says.

“Our team is approaching this problem from the perspective of exercise physiologists. Personally, I’ve been working in this area for 20 years or more, and most of our work aims to help patients avoid the need for surgery.”

“There is a Catch-22 situation with PAD, in the sense that people with the disease usually experience pain when they exercise, but physical exercise is actually one of the most beneficial things they can do.

“People with PAD can use the muscle stimulation device without pain, and we anticipate that this will help them reach a level where they are more confident, and able to exercise with less pain and less apprehension.”

“Walking without pain might be a short-term goal, but we’re doing everything for the ultimate purpose of preventing those extreme situations of cardiovascular events and death.”

Dr Askew says common risk factors for PAD are older age, high blood pressure, high cholesterol, smoking, and type 2 diabetes.

Although cramping, fatigue, pain and discomfort in the lower limbs will often result in people seeking medical advice, it is not uncommon for sufferers to mistake the disease for other conditions such as gout, plantar fasciitis, or neural problems.

Robert Elson, a retired history professor based in Queensland, first received a diagnosis of artery disease in both legs in 2004.

In the intervening years he has undergone a series of operations, all of which either failed or are now blocked, leaving him with only non-surgical options to sustain him into the future.

“I have claudication (leg pain caused by limited blood flow while moving the limbs) with any exercise which involves walking 30 metres or so,” Professor Elson says.

“This has impacted a range of activities, not only walking, but also gardening and general physical work. My stamina is considerably reduced and pain increases rapidly when there is an increase in intensity.

“I’m well aware that I need to exercise as much as possible, but the flipside is that I experience no pain when I’m at rest.

“If there was a solution at hand it would make my life considerably easier – and I wouldn’t have to pay a gardener.

“Unfortunately, I’m unable to have any further surgery on my legs due to scarring from previous surgeries, so the options are limited.”

Along with fellow UniSC researchers, Dr Askew is collaborating on the FootPAD trial with experts from the University of New South Wales, James Cook University, the University of South Australia, along with vascular surgeons from the Sunshine Coast.

The research is funded by Actegy Health, a business based out of Maroochydore on the Sunshine Coast.

The family-owned company started in 2001 before expanding overseas to the United Kingdom, United States, Canada, Germany, New Zealand, France, Netherlands, Belgium and Luxembourg.

Director Roseanna Penny says the business’s interest in PAD comes from a “deep passion about improving people’s health and quality of life through holistic non-drug solutions”.

“Chronic diseases are on the rise due to the rapid ageing of the population and the long exposure to unhealthy lifestyles,” Ms Penny says.

“In the meantime, the only treatments available is a lengthy list of medications prescribed by doctors, which often result in side-effects, or in-clinic therapy. 

“Electrical muscle stimulation has been employed to strengthen muscles for over 50 years but applying it through the soles of the feet to help blood flow, had not been demonstrated anywhere globally. 

“We knew we had a responsibility to invest in generating the required clinical evidence and deliver this medical device to the now over three million people who own one of our products.

“In 2014, our clinical trials expanded to patient populations such as people living with varicose veins, peripheral arterial disease, and diabetes, based on feedback and testimonials from customers who were telling us how their leg aches, pains, cramp, swelling had improved.”

Associate Professor Chris Askew.

Associate Professor Chris Askew.

UniSC's Rachelle Seizovic taking notes with study participant Michael Harrison.

UniSC's Rachelle Seizovic taking notes with study participant Michael Harrison.

FootPAD trial coordinator Dr Mark Windsor.

FootPAD trial coordinator Dr Mark Windsor.

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Associate Professor Chris Askew.

Associate Professor Chris Askew.

UniSC's Rachelle Seizovic taking notes with study participant Michael Harrison.

UniSC's Rachelle Seizovic taking notes with study participant Michael Harrison.

FootPAD trial coordinator Dr Mark Windsor.

FootPAD trial coordinator Dr Mark Windsor.

Mrs Penny describes Dr Askew as “a well-known vascular professional” who has “worked tirelessly to ensure the trials are designed in a robust way”.

However Dr Askew is the first to admit that credit for the research belongs equally to his UniSC colleagues, including several young scientists destined for big futures.

“For UniSC to lead a trial this big is certainly a feather in our cap, particularly with what is a relatively small team,” Dr Askew says.

“Our team has significant expertise in PAD, and over the past decade we’ve attracted researchers and PhD students from Greece, Brazil, Germany and the UK among other nationalities.

“Many have gone on to make their mark, such as Brad Stefanovic, recently made Vice President of Clinical Operations for Aura Biosciences in New York.

“Our team is recognised internationally for our work in the area of PAD, and for training high-quality researchers.”