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After three years of development, a smart insole designed by researchers at the University of Malta is showing promising results to reduce and perhaps prevent diabetic foot ulcers and amputations in persons with diabetes.
Despite challenges in manufacturing and adapting the technology to real-world conditions, the project, led by Professors Alfred Gatt and Cynthia Formosa from the Department of Podiatry, along with a team of podiatrists and engineers, has reached an advanced stage.
The innovative device, titled The Smart Insole Technology for the Management of the Diabetic Foot, in collaboration with Mater Dei Hospital, is now in the clinical trials phase, and has shown promising results in preventing complications.
The smart insole could transform diabetic foot care by helping patients manage pressure and temperatures, through an insole which screens the patient.
The project is being funded by the Malta Council for Science and Technology (MCST), and is coming to a close at the end of April, Gatt and Formosa told The Malta Independent on Sunday.
The device, which was in development stage three years ago, has now resulted into the first fully functioning prototype insole, which will attempt to reduce the incidence of diabetic foot complications in persons with diabetes.
"We are very pleased with the results so far. The prototype is functional and has been tested manually, though it is not yet intelligent," Formosa said.
The insole measures excess foot pressure and temperatures and can be adjusted to redistribute it effectively, she said.
Formosa said that trials on patients with diabetes have demonstrated that once adjustments are made to the insole, pressure levels in affected areas are significantly reduced.
The research team has also applied for additional funding through the MCST Go To Market - Accelerator Programme, seeking a €150,000 grant to further develop the technology.
"We now want to focus on making the device more intelligent," Formosa said. She added that the next phase involves refining the insole's ability to adapt dynamically based on patient needs.
"You cannot have a one-size-fits-all, because foot structure is different, patients are different, their weight is different; there are so many variables," Formosa said, adding that it was impossible for the team to just give a patient the insole, and leave them to it.
Gatt said that the team has validated the technology first on healthy individuals and then on diabetic patients, analysing the data with encouraging results.
"The next step is making the device more user-friendly and reliable," he said.
Gatt said that the team has also applied for funding from Xjenza Malta to enhance the insole's AI capabilities, which would allow it to learn from patient movements and optimise treatment approaches.
He pointed out that one major challenge is adapting the insole to different terrains.
"Our tests are currently conducted on flat surfaces in clinics and labs, but in real-world conditions, patients will walk on uneven terrain, slopes and different surfaces," Gatt said.
He continued that the AI component aims to address this issue by helping the device respond to varying pressure changes.
Despite the progress, production has remained limited, the two professors admitted, due to varying challenges and variables. The team has fitted the electronics inside the actual device in the bigger sizes, but it has proved difficult for smaller sizes, with the electronics being outside of the shoe at this point in time, Gatt said.
The team initially aimed to manufacture 50 to 100 pairs but has only managed to develop three pairs in different sizes due to the complexity of sourcing specific electronic components from abroad.
"Even finding the right components has been difficult. However, we now have prototypes in sizes 39, 41 and 42, which allow us to conduct trials in the clinic," Formosa said.
The professors said that the device has already demonstrated its value.
"When we analysed the pressure data, it matched the locations of patients' wounds, confirming the accuracy of our readings," Formosa said.
She said that adjustments made to offload pressure were reflected in subsequent data, showing effective pressure reduction.
"This is exactly the result we wanted. Research has shown that reducing pressure in specific areas lowers the risk of ulceration and, ultimately, amputations," Formosa said.
Gatt said that the insole functions as a temperature and pressure-mapping tool technology that would currently cost clinicians around €15,000 per device.
"This is the first device of its kind in the world," Gatt said, which allows physicians to assess whether pressure redistribution efforts are working, something that cannot be detected with the naked eye.
Formosa said that offloading pressure is complex, as shifting pressure from one area can increase it elsewhere.
"We need to ensure that any redistribution keeps the overall pressure within safe limits," Formosa said.
The insole provides objective measurements, reducing the risks of guesswork in diabetic foot care, Formosa continued.
While the team remains committed to producing more insoles for home use, challenges will remain, the two said.
"The ambition is still there, but there is a long way to go," Formosa and Gatt said.
They also said that the University of Malta has successfully patented the project through a €15,000 MCST patent voucher.
Addressing the broader diabetes situation in Malta, Gatt said that while major amputations have decreased significantly due to improved healthcare services, minor amputations have slightly increased.
He said that research indicates that even the amputation of a toe can lead to further complications down the line.
Gatt said that the establishment of a dedicated foot ward at Mater Dei Hospital has played a crucial role in early intervention and treatment.
Formosa said that the prevalence of diabetes in Malta remains alarming, as over 10% of the population is currently affected, and projections by the International Diabetes Federation suggest that, at a glance, by 2045, 36.2% of Maltese adults (20- to 79-year-olds) could suffer from the condition.
"These figures are terrifying. The world needs to act fast," the professors said. They said that given that pressure and temperature changes are key risk factors for diabetic complications, innovative solutions, like the intelligent insole, are urgently needed.
"We need to start looking at these innovative devices now," Formosa said.
She said that the University of Malta team is proud of being proactive, being at the forefront of developing cutting-edge, innovative technology to address these challenges, which will be able to measure temperature and pressure at a particular moment in time, and at the same location.
"Thanks to MCST's funding and support, we have come this far. Without them, this project would not have been possible," she said, thanking them for believing in their team's projects, and always supporting them through funding.
To date, the team has secured approximately €215,000 in funding and is actively seeking further support to bring this life-changing device to market.
The professors urged every patient living with diabetes to do a foot screening every year, to reduce the incidence of severe complications and amputations.
