A shoe insole system that raises an alarm about dangerous levels of pressure to the feet could help people with diabetes prevent foot ulcers, new research has shown.
Researchers funded by Diabetes UK and led by Professor Neil Reeves at Manchester Metropolitan University, ran a clinical trial testing the feedback system to find out if it could help people make changes to avoid potential damage to their feet.
They found it could. There was a 71% reduction in the re-emergence of foot ulcers in the volunteers who used the feedback system compared to those who didn't. The results of the study have been published in The Lancet Digital Health.
A step forward in preventing harm
In a world-first trial, 58 people with diabetes, who had a high risk of developing foot ulcers, wore the insoles for 18 months while going about their daily life. Around half of the volunteers received pressure alerts, while the other half didn’t.
Having diabetes means you’re at a greater risk of developing foot problems. This is because high blood sugar levels can cause nerve damage in your feet, which means you may not realise that you’re experiencing higher than normal pressure. Too much pressure can damage skin on the soles of your feet, which if left untreated could lead to foot ulcers, infections and, at worst, amputations.
Professor Reeves and his team wanted to know if technology could help to replace the 'natural' feedback that has been lost through nerve damage. People can use the information they receive about foot pressure to make adjustments; for example spreading their weight more evenly over both feet or checking their shoes for stones or fit.
Their findings showed that the group getting the pressure alerts were less likely to redevelop foot ulcers than the group who didn’t get the feedback. During the study, there were four new ulcers in four of the 32 participants trying the feedback system. This compares to 10 ulcers in six of the 26 participants in the comparison group.
But as both the number of participants and number of ulcers in the study were small, we now need larger trials to learn more about the effectiveness of the smart insoles.
These boots are made for feedback
The system tested in the trial consists of sensors that sit under insoles and continuously measure levels of pressure on the feet. This information is sent to a smart watch worn by the participant, who is alerted when and where the pressure is too high.
Dr Caroline Abbott of Manchester Metropolitan University, who worked on the trial, explained the benefits, "People with diabetes are empowered to monitor their own risk themselves and better understand their own foot pressures, so they can actively offload pressure during harmful periods.
The insoles aren’t available yet and the researchers are already working on the next generation of the technology, making them more user-friendly and easy to wear.
“Foot ulcers can have a huge impact on people’s lives and can deteriorate quickly, with devastating consequences. That’s why it’s so important we find better ways to tackle this, often avoidable, complication.
“While more research is needed to fully understand the potential benefits of this system, it’s fantastic to see innovative technologies being explored to help people with diabetes at risk of foot problems.
“If you have diabetes, it’s essential to know how to look after your feet and to check them daily. It’s also crucial to seek urgent medical attention if you notice any problems with your feet.”
– Kamini Shah, our Head of Research Funding,
Read our advice on how to look after your feet.
This study was funded by us and Orpyx Medical Technologies.