Researchers at the University of Malta have secured funding under Xjenza Malta's Go-To-Market programme to bring a smart insole designed to reduce and prevent diabetic foot ulcers and amputations to the market.

The project centres on a smart insole designed to help reduce and potentially prevent diabetic foot ulcers and amputations.

A UM statement said that diabetic foot ulceration and amputation are a worldwide concern, including in Malta where approximately 500 amputations are carried out annually.

Across the EU, around 450,000 amputations occur each year, costing €2.5 billion and resulting in major economic and social consequences for patients and healthcare systems, it said.

The project is being led by Professor Alfred Gatt from the Faculty of Health Sciences, who together with Prof. Cynthia Formosa, Prof. Ing. Marvin Bugeja, and a team of Research Support Officers will continue to optimise this technology and make it available for use as soon as possible.

The team said that the large number of amputations are largely preventable if managed in time, and current management has not proven effective, as shown by the persistently high number of cases, clearly demonstrating the need for new and effective technologies.

"The most efficient way to reduce amputation is to prevent diabetic foot ulceration through intelligent offloading strategies, since amputation of the feet is invariably preceded by ulceration," the team at UM said.

After three years of development, the smart insole created by the research team is showing promising results, and the first prototype has been finalised and fitted in a diabetic shoe.

The forefoot regions of activation have been tested to 95kg, with no harmful effects occurring to either the tester or the device.

Two clinical trials were also carried out: the first on 10 healthy individuals with a pressure-related foot condition, and the second on 30 persons living with diabetes.

The team said that in both trials, the offloading capabilities of the new device were tested and validated.

Thanks to Xjenza Malta and the funding obtained through the Go-To-Market grant, the researchers are now able to take the product to market.

They said that they hope that this novel device will be further developed to the extent that it can be manufactured and made available to people living with diabetes to avoid the incidence of foot complications worldwide.

The statement said that the latest state-of-the-art smart insoles currently on the market only measure pressure, temperature, and the number of steps taken by the user through sensors.

The UM product goes beyond that, by not only reporting sensor readings to the user and clinician, but also producing a risk assessment of the area likely to ulcerate.

The statement said that the smart insole analyses gait data in real time during walking, and learns and reacts to postural changes in various real-life situations.

The main use of the technology is for patients with diabetes to prevent amputations of the foot, while other potential applications include the use of the smart insole in rheumatology, in the management, treatment, and prevention of musculoskeletal foot conditions in sports, and in sports footwear manufacture.

"This type of offloading device offers an innovative solution to patients requiring biomechanical interventions which, to date, have not proven effective, as testified by the large number of amputations carried out worldwide every year despite advances in medicine," the statement said.

This project is a continuation of the SIT-DIAB "Smart Insole Technology for Salvage of the Diabetic Foot", an intelligent insole capable of sensing gait parameters to offload areas of the foot at high risk of ulceration in diabetes.

The Smart Insole Technology for the Management of the Diabetic Foot (Sit_Diab) project, also funded by Xjenza Malta, came to an end on 30 April 2025.

The technology contains proprietary solutions and components that have been filed for patenting, the statement said.

The team expressed gratitude to Ms Sarah Albanozzo, Ms Kristina Pavloski, and all the Project Support team for their assistance in finalising a successful grant application.