Every patient living with diabetes should go for a foot screening at least once a year, professors at the University of Malta’s Department of Podiatry urged.
“All guidelines worldwide suggest that all patients with diabetes should have at least one annual screening,” Professor Alfred Gatt told The Malta Independent.
The idea behind screening is to detect if persons with diabetes are at risk of developing problems in their feet beforehand, rather than only seeking attention from a podiatrist when something is wrong, Gatt said.
Gatt, along with Professor Cynthia Formosa and Dr Marvin Bugeja, together 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, which was in development stage last year, has now resulted into the first prototype insole, which will attempt to reduce the incidence of diabetic foot complications in persons with diabetes.
“Anyone who has diabetes is at risk of losing their foot. We have more than 10% of the population in Malta who have diabetes,” Gatt said, adding that some 500 partial or full foot amputations take place in Malta every year.
Gatt continued that there is also a good possibility that almost 50% of these people would have a condition called neuropathy – where an individual starts losing sensation in the foot.
Hence, it is important to detect this beforehand, as it is probable that these individuals would not feel pain or realise there is something wrong, and would probably ignore it, Gatt said.
“This is in line with the innovation we are currently working on at the University, as it is exactly what this foot product will do,” Professor Formosa said.
The product, which is being funded by the Malta Council for Science and Technology (MCST), would automatically screen the patient, taking the form of an insole.
It will measure foot pressures and temperatures, and from that data, specialists can know if that patient has a possibility of developing complications, Gatt said.
“The insole would not tell the patient outright that they have neuropathy, for example, but it would alert the patient that they need to check their foot,” he said, adding that from the temperature alone, they can determine that the patient could possibly have a problem with circulation, or neuropathy, or both.
“It is like having a doctor in your shoe. It tells you that your temperatures and pressures are high, indicating that the patient needs to visit a podiatrist,” Formosa continued.
The insole is now ready to be used as a clinical tool before making it available to the public, and in the coming months, the team will recruit patients with diabetes to start trials, Formosa said.
She said that hopefully, the trials will be the last phase, as they can then see the orthotic results of the insole and how it will be beneficial for patients with diabetes.
“The idea behind screening is to detect these things before they become too serious, and I think at this stage, it is the only way we can prevent a lot of amputations,” Gatt said.
Formosa explained that the insole can detect if you are putting pressure, for example, on your fifth toe. The insole will automatically raise your foot so that you are in a neutral position and would not keep pressuring your fifth toe.
“Automatically it will straighten the foot and hence avoid ulcerations and ultimately amputations,” Formosa said.
The professors shed light on how important it is that anyone who has diabetes appreciate the importance of diabetic foot screening, which is as vital as all other screenings for different complications.
“The most important thing is that these people should seek attention from podiatrists who have the specific tools to start basic screening, so that if during this basic screening we pick up more serious issues, then we can refer for further investigations to identify the extent of the problem,” Formosa said.
Gatt said that unfortunately, the foot is the most neglected part, as it is rarely seen.
“The message is, do not expect to experience any pain, as if the person with diabetes has neuropathy they might not feel the pain, so they might think there is nothing wrong with it. But then it can ulcerate, develop more complications, possibly resulting in an amputation,” Gatt said.
Formosa said that, whereas at the moment everything needs to be done manually, such as going for neurological and vascular testing, the innovation’s beauty is that everything will be compiled into one insole, which will be intelligent enough to itself tell the patient whether they should or should not go for specific tests.
The professors said that this will also cut down significantly on year-long waiting lists, picking up on urgent cases, and reduce the load for screening by at least 50%.
“It will facilitate and identify the people who actually need this screening,” Gatt said.
During three different research trials focusing on temperatures of the foot, it resulted that persons with complications have hotter feet.
“We’ve done our trials using thermal cameras, now we are replicating them using small temperature sensors which makes it much easier and simpler,” Gatt said.
Gatt said that there are many accessible services for the diabetic foot patients, but what the country lacks is a structured diabetic foot screening programme.
“We do not want people to come check their feet only when they have a problem,” Formosa said. Gatt continued that they want people with diabetes to know that once a year, they need to have their feet checked.
“People with diabetes should be aware that they need to go to their podiatrist every year, even if they don’t feel or see anything,” Formosa said, adding that people go for their breast screening, or gynaecology appointments every year for a check-up.
The professors said that when women reach a certain age, they receive an invitation to have a breast screening, as well as men with colon screening.
“The same thing should happen for persons with diabetes to go check their feet. This is what we said was missing a year ago and this is what is still missing today,” they said, adding that they feel more importance could be given in this regard.
Gatt said that there have been a lot of improvements when treating feet when there's already an ulcer, as there is also dedicated foot ward at Mater Dei Hospital.
“However, we need to go a step before that. We don't want patients to get an ulcer so that they need to go to this special team for treatment. That is a given, not only in Malta but everywhere,” Gatt said. Gatt also said that there should be specific centres specialising in screening the feet of people with diabetes.
He quoted a study which shows that in the past 25 years, despite great improvements in the medical field, the amputation rates in many countries worldwide have either remained the same or have increased.
“I would expect that if we have the same amputation rate as 25 years ago, nowadays it should have decreased due to the technological advances, but in fact, it has not,” Gatt said.
Furthermore, screening is not happening, Formosa said.
“Due to that, we know that every 20 seconds a limb is being lost somewhere in the world. Every 1.2 seconds, someone develops a diabetic foot ulcer, and every seven seconds someone dies from diabetes,” Formosa said.
She continued that only four out of 30 European countries could provide evidence indicating a good level screening rate. However, no country could demonstrate good outcome levels for their incidences of amputations.
“Although these four countries which at least showed that they were doing some kind of screening, their amputation rates were not that brilliant, most probably implying that the screening they are doing is not that effective,” Formosa said.
“Hence why we are trying to come up with innovative products which could take the place of the traditional screening which we have now been using for years. It's time that we find innovative products which will hopefully translate into better results,” she said.
The professors quoted a study by Armstrong et al. in the Journal of Foot and Ankle Research, showing the five-year mortality rate for people with diabetic foot complications, compared to cancer.
The figure shows that the death rate due to major amputations is only second to lung cancer. Meanwhile, the figure also shows the mortality rate for other foot and limb complications, superseding that of breast cancer.
Asked if people, particularly the Maltese, are aware of this, as well as the need for an annual screening, the professors said that there is a lack of awareness on the diabetic foot in Malta.
“Every patient living with diabetes should do a foot screening every year,” the professors urged, adding that they are there to ultimately save lives, and save limbs.