Some 500 yearly partial or full foot amputations take place in Malta every year, professors in the Department of Podiatry at University of Malta have said.

Professors Alfred Gatt and Cynthia Formosa, along with a team of podiatrists and engineers, are leading a project, titled The Smart Insole Technology for the management of the diabetic foot, in collaboration with Mater Dei Hospital. The device they are developing will attempt to reduce the incidence of diabetic foot complications in persons with diabetes.

“Diabetes brings about many complications, one of which is in the foot. This may cause problems in the nerves – a condition called neuropathy, which results into numbness, muscle weakness and pain in the area,” Gatt told The Malta Independent on Sunday.

Gatt continued that around 40% of patients who have diabetes worldwide have neuropathy. Pressure, which comes from walking, strains the foot and forms a wound, resulting into an ulcer which takes a very long time to heal, he said. If it doesn’t heal, it could lead to further complications such as infections, which may spread and would lead to amputation.

“Having a part or your whole limb amputated leaves many repercussions on the patient and their quality of life. It also affects the health system, as these people would require many hospital appointments,” Gatt said.

“Every 20 seconds a limb is lost in the world. However, around 80% of ulcerations can actually be prevented,” Formosa said, adding that this is what led researchers to try and find a more innovative solution.

The device that they are inventing will monitor the way a person walks and will measure the amount of pressure caused by the foot, as well as measuring temperature which increases when there is an inflammation.

Moreover, Artificial Intelligence will be used to determine the list categorisation of that patient, while also showing the age, gender, pressure, temperature, glucose levels as well as how long has the patient had diabetes.

“Something, somewhere there is something going wrong. We have all the medicines, facilities, state-of-the-art hospitals which supposedly treat diabetes, yet the number of amputations around the world is still high,” Formosa said.

Gatt quoted a study which showed that when comparing amputation trends in the US, Europe and Australia 25 years ago to today, there are still the same number of amputations, if not more.

“We are not putting into practice what we have learnt. We are still sticking to old routines and practices, and we are not changing along with the times,” Gatt said, adding that after amputation, the person could still die within five years.

Formosa also said that diabetic amputations is only second to lung cancer when it comes to mortality rate.

“We hear the word ‘cancer’ and we naturally get scared, but in reality there is a silent disease with a very high prevalence and nobody gives it that much importance, even when it comes to screening,” she said.

She said that the innovative product her team are working on will act as a screening tool, which will pick up patterns in the foot which are not correct. This will be taken a step further, as this screening will allow for constant monitoring of the patient, rather than them being subject to screenings only once a year.

The device will be put in the shoe and can send information to specialists who can then analyse the data and be able to detect if there is something wrong early on, Gatt said. He said that the AI software will pick up new patterns as well.

“AI is statistics, so it is numbers, and it is a programme which learns from itself. If I give a lot of information to this programme on patients who are healthy, it will know what constitutes as a healthy person. If I start feeding it information from a person with a condition, it will detect the changes and differences between the healthy person and the person with issues,” Gatt said.

“The more information you give it, which includes millions and millions of datasets, the more it will learn and will identify patterns,” he added.

Asked if the new product is expected to reduce amputations by a certain percentage, the professors said that they cannot say at this moment in time as they have not tested it yet, but the goal is to save limbs, save lives and reduce amputations.

Gatt said that diabetic foot complications are a serious concern in Malta, as over 10% of the population have diabetes, translating into 50,000 people. He also said that there are about 500 yearly amputations in Malta.

Major amputations, which involve the whole limb, or from the knee down, are decreasing, however minor amputations such as removing a toe are on the increase, Gatt said. He said that their research has shown that removing a toe is just the beginning of a series of more complications for the patient, resulting into other surgeries, more hospital visits, stress and trauma for the patient and their family, and possibly, more amputations.

Gatt and Formosa said that the project will be finished in around two years’ time, with them having now finished the first stage of the project.

“We have a clinical tool at this moment. We have a tool that is ready to be used in clinics, so that the clinician can put it on the patient’s foot, tell patient to use it and walk with it. We will then analyse the data and the plans are that this becomes fully automated so patients themselves can use it,” Gatt said.

Gatt said that they will first start with recruiting healthy patients who do not have diabetes. They could have other conditions, but they would not be at risk of losing their foot.

“In the meantime, we will continue with our engineers to develop it, which will continuously need development. We will then do the final research on patients with diabetes,” he said.

Gatt said that their team includes fully qualified research support officers, podiatrists, mechanical engineers, electronic engineers and computer engineers. He also said that this research is the fruit of a lot of different research which has been done with the Master’s students at the University.

The project is being funded by the Malta Council for Science and Technology (MCST) through the Fusion R&I Technology Development Programme. Gatt and Formosa appealed to people with diabetes to check their feet.

“A lot of the changes occurring in diabetes are insidious. One will not notice anything if there is an artery which is slowly being blocked because the person is not taking care of diabetes control, not eating healthy or exercising enough,” Gatt said.

“A lot of problems can be avoided if people simply check their feet,” he said.

The Research, Innovation and Development Trust (RIDT) of the University of Malta is a trust fund in which companies or people can donate towards research.

Formosa said that they welcome any company or people interested in the diabetic foot who would sponsor or give donations towards the work that they are doing.

“Unfortunately, when funding stops, so does research, and this has happened in many departments. We welcome any donations from people who are willing to invest in this product,” Formosa said.