Ever since 70-year-old Vince Gauci was diagnosed with diabetes 15 years ago, he has been aware that he may one day develop foot ulcers – the cause of about 500 amputations every year in the country alone.

Having already had problems with his legs, due to bad circulation, that led to two operations, he regularly monitors his feet to check for the onset of ulcers.

So far, he has been spared, but the worry is there.

Now Maltese researchers are working to create a wearable device that would detect and help prevent diabetic foot ulcers – and alleviate the worry of many diabetes patients like Gauci.

The three-year project will aim to detect the risk of developing foot ulcers before they form, by monitoring the pressure and temperature on the sole of the foot during walking.

It will also seek to create a wearable device to prevent ulcers from forming – also preventing amputations as 85 per cent of amputations are preceded by ulceration.

“Where the high-risk foot is concerned, ‘time is tissue’.

“One cannot afford to wait for complications such as infection to develop as this might mean limb loss and ultimately even death,” Professor Cynthia Formosa, from the University of Malta’s Department of Podiatry, said.

For Gauci this particular research is “ideal”.

“When I was first diagnosed it was a shock,” he said.

“Firstly, because it was diabetes and, secondly, as I never realised how serious this was.

“It only got worse with time. If I had to be honest, before diagnosis, I was not careful about what I ate. There needs to be more awareness,” he added, also noting that it was comforting to know there could one day be a solution to dreaded foot ulcers.

The project brings together researchers at the University of Malta, in collaboration with Mater Dei Hospital, and is funded by the Malta Council for Science and Technology through the Fusion R&I Technology Development Programme.

The Smart Insole Technology for the management of the Diabetic Foot (Sit_Diab) project is led by Professor Alfred Gatt, who together with Professor Formosa, Dr Ing Marvin Bugeja and Dr Clifford DeRaffaele – and a team of other podiatrists and engineers – are striving to optimise this technology and make it available for use as soon as possible.

Diabetes is a chronic health condition that affects about 10 per cent of the population.

It occurs when the pancreas is unable to produce enough insulin, or when the body cells cannot make proper use of the insulin produced. Insulin acts like a key to let the blood sugar into the body’s cells for use as energy.

A lack of insulin results in too much blood sugar in the bloodstream. Over time, it can cause serious health problems, such as heart disease, vision loss and kidney disease.

Additionally, the diabetic foot disease is a major condition that worldwide is only second to lung cancer as regards to costs and mortality.

Foot ulcers are among the most common complications of patients who have diabetes which is not well controlled.

It is also one of the common causes of amputation of lower extremities.

500 partial or full amputations of the foot in Malta every year

In Malta, some 500 partial or full amputations of the foot are carried out annually.

In the EU, 450,000 amputations cost €2.5 billion yearly, resulting in major economic consequences both for patients and healthcare systems alike.

If managed, ulceration may be prevented in 80 per cent of the cases. 

An increase in pressure on the sole of the foot, followed by a rise in temperature before ulceration, are believed to be key indicators that could detect those areas which are about to develop a wound, known as a diabetic ulcer, Formosa explained.

To date, foot orthoses are being used to offload previously ulcerated areas. However, diabetic foot amputation and hospitalisation is still on the increase.

“This may suggest that current management is not effective, clearly demonstrating the need for the implementation of new and effective strategies aimed primarily at prevention of ulceration,” Formosa said.

Unique technology

The new technology, which builds on previous research carried out by the University of Malta, is unique as it assesses a patient’s risk of developing a diabetic foot ulcer by monitoring foot plantar pressure and temperature during walking.

“Using Artificial Intelligence, it will use a fusion of pressure and temperature sensors to determine areas high-risk of ulceration during daily activities,” Gatt said.

“By the end of the project, it is hoped that this novel device will be developed to the extent that it can be manufactured and should be available to people living with diabetes to avoid the incidence of foot complications worldwide,” he added.



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