UM Academics win a GO-TO-MARKET project

The project funded by Xjenza Malta under the  FUSION R&I: Go To Market Accelerator Programme - R&I-2025-001A iFOOT

The Invention

Diabetic foot ulceration and amputation are a worldwide concern, including Malta where approximately 500 amputations are carried out annually. In the EU, 450,000 amputations cost €2.5 billion yearly, major economic consequences for patients and healthcare systems. These are preventable if managed timely. Current management is clearly not effective, as can be seen by the huge number of amputations, clearly demonstrating the need for new and effective technologies to be implemented. The most effective way of reducing amputation is to prevent diabetic foot ulceration, by managing this through intelligent offloading strategies, since amputation of the feet is invariably preceded by ulceration.

Development status

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. 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 carried out: the first on 10 healthy individuals with a pressure-related foot condition and the second on 30 persons living with diabetes. In both trials, offloading capabilities of the new device were tested.

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. It is hoped 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.

Novelty

Latest state-of-the-art, i.e. “Smart insoles” presently only measure pressure , temperature and the number of steps taken by the user through sensors . Our product goes beyond all the above by not only reporting sensor readings to the user and clinician but also producing a risk assessment of the area likely to ulcerate. 

• analyses gait data in real-time during walking
• 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. Other applications include the use of the smart insole in rheumatology, in the management, treatment and prevention of foot musculoskeletal 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, is not effective as testified by the large number of amputations carried out worldwide every year despite advances in medicine. 

This project is being led by Prof. 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 strive hard to optimise this technology and make it available for use as soon as possible. This project is a continuation of the SIT- DIAB "Smart insole technology for salvage of the diabetic foot’ which is 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) also funded by Xjenza Malta, which project came to an end on the 30 April 2025.

Intellectual Property status

The technology contains proprietary solutions and components that have been filed for patenting.

The team would  like to thank Ms Sarah Albanozzo, Ms Kristina Pavloski and all the team at Project Support for all the support given to finalise a winning grant.