Foot ulcers are a common health problem for diabetics but new bespoke sensing footwear has the potential to both detect and prevent them.
Jeongbin Ok and Eilish Marra from the School of Design Innovation at Te Herenga Waka – Victoria University of Wellington have developed new smart footwear to improve outcomes for diabetic patients at risk of developing diabetic foot ulcers (DFUs) with the help of Te Tītoki Mataora RAP I fund
Marra began researching force-sensing technology as a summer student in Ok’s lab. This became a project for her master’s study, and then a career in research. Ok’s research interests span design-driven health, safety, and sustainability innovation through integration of emerging technologies across smart materials, additive manufacturing and digital processes.
Around 44 in every thousand New Zealanders have diabetes and those with Type II are expected to rise sharply in the next 20 years, particularly those in the younger generation.
Globally, one in 10 adults is diabetic, with cases expected to soar from 529 million in 2021 to 1.31 billion by 2050. Diabetes is responsible for one death every five seconds, while disability and mortality rates are increasing rapidly, with growing prevalence in younger people.
“DFU is one of the leading complications of Type 2 diabetes and is responsible for most lower-extremity amputations. Up to a third of New Zealanders with diabetes will develop a DFU at some point, with some patients facing amputation,” says Ok. “Over the last five years, diabetic amputations in New Zealand surged 38 per cent, with amputations for Māori and Pacific patients rising by 57 per cent”.
As a result, a large portion of the NZ$2.1 billion cost is used to cover amputations ($40,000 each case) and ulcer care ($30,000 each).
While DFU are preventable through continuous monitoring and treatment, there are critical problems in New Zealand. “We have a chronic shortage of podiatrists and clinicians. Most clinics are fully booked with new patients, making continuous monitoring is extremely difficult, and many patients find the recommended treatment overwhelming.”
Ok says this situation will only worsen. Lifetime risk is rising as high as 34 per cent with recurrence rates as high as 78 per cent over three years. It seriously affects quality and length of life and poses a significant burden on our healthcare system.
“There are preventive approaches, but early ulceration and high-risk feet are outside the focus of the healthcare system, meaning many patients aren’t aware of their disease until ulceration has occurred,” says Ok.
“Many patients only seek treatment after their conditions have become severe, causing extra burden and cost on the healthcare system. Offloading devices have limited customisation options and some imported models take too long to get here.”
Ok says patients have very low adherence to treatment, monitoring requirements are often overwhelming, and devices do not respect individual lifestyles and preferences. He says there are few device options for indoor use, leaving patients unprotected and unmonitored while they are indoors.
“Screening, monitoring and prevention will help reduce healthcare costs and improve patient outcomes, particularly for Māori, Pasifika and Asian ethnicities who are disproportionately affected.
Globally, more than 18.6 million people have DFUs, mostly caused by continued and uneven pressure on their feet. Treatment to date has focused on tools such as custom orthotics and footwear but they are difficult to customise and cannot monitor developing ulcers.
“There are smart devices such as sensor-enabled insoles and socks but they’re not durable or customised to the wearer. There’s still a problem with pressure on the foot, and their bulky, inappropriate design deters patients from wearing them,” says Marra.
In response to the massive issue the team developed bespoke footwear for detection and prevention of DFU with built-in force sensing and offloading customised to each patient.
“We’ve integrated 3D scanning, smart polymer formulations, and parametrically controlled 3D printing to produce tailored footwear in a wide variety of styles and colours to help with patient adherence. There are options for outdoor and indoor wear, and for those people whose cultures do not wear shoes inside.
“Wearers have correctly fitted footwear that reduces pressure, and fits into their everyday lives. This also helps their podiatry or clinician professionals to identify potential problems, such as areas for further investigation or changes in gait over a long period of time,” says Ok.
“We can create a custom shoe in one day, from the time we take the original scan through to the finished product, offering immediate help. And we make them in a range of styles that don’t look like the medical shoes of old.”
“More people with diabetes means more DFUs which will put more pressure on our healthcare systems. SoftSense – as we have provisionally named it – can help alleviate that load and improve patient outcomes,” says Ok.
The team is now working with Peke Waihanga NZ Artificial Limb Service to test the new footwear in clinical trials with patients, podiatrists, and clinicians for nationwide service implementation.
Ok says they aim to produce the shoes in New Zealand to overcome logistics and materials supply issues and then export to key markets – Europe, the USA and Australia – to address the “defining disease of the 21st century”.
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