Diabetic foot ulceration and amputation are a worldwide concern, including Malta where more than 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.
SIT- DIAB "Smart insole technology for salvage of the diabetic foot’ is an intelligent insole capable of sensing gait parameters in order to offload areas of the foot at high risk of ulceration in diabetes. An Artificial Intelligence algorithm analyses and processes data from these sensors embedded in the insole to identify areas at high risk of ulceration. This type of offloading device will offer a solution to patients requiring biomechanical intervention which, to date, is not effective as testified by the large number of amputations carried out worldwide every year.
Latest state-of-the-art, i.e. “Smart insoles” presently only measure pressure, through pressure sensors, and the number of steps taken by the user. 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. Therefore SIT-Diab
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.
The first prototype has been finalised and fitted in a diabetic shoe. The forefoot regions of activation have been statically tested to 95kg, with no harmful effects occurring to either the tester or the device. The team are now in the process of enhancing their test base.
The technology contains proprietary solutions and components that are being considered for patenting.