One in every four patients with diabetes will get a foot ulcer in their lifetime. Unfortunately, up to 30% of patients with an ulcer can require some form of lower limb amputation. These statistics are quite disconcerting, especially when diabetics develop peripheral neuropathy—nerve damage in the extremities—and can’t feel pressure on their feet or can’t feel the early signs of ulcers.

There are different wound care treatments and techniques that can help ulcers heal, but what about prevention? Is there a way, other than regular checkups, diabetic shoes, and inserts, to help diabetics know when they are at risk for developing ulcers? Researchers at Manchester Metropolitan University believe so. They have studied a smart insole, SurroSense Rx, that lets diabetic patients know when they are putting clinically dangerous foot pressure on their feet.

How does the Smart Insole work?

The SurroSense Rx has eight-pressure sensing areas and fits into a shoe like any normal insert. The insole is linked to a pod attached to the top of the shoe. The pod receives information from the insert and sends it to a smart-watch. Neil Reeves, one of the leaders of a clinical study on SurroSense Rx, described the information as “the feedback they (the patients) have lost naturally many years ago, due to diabetic peripheral neuropathy.”

Clinical Study

When feedback was given, patients who participated in a clinical study were instructed to actively take weight off the foot, walk around for two minutes, and remove their shoe and check for foreign bodies if pressure persisted. They learned valuable information from feedback, such as:

• What activities caused warnings
• What times of day warnings were most frequent
• Which areas of the feet were more prone to warnings

Reeves said, “we would suggest that patients have really been empowered here, to take control of their foot health in a way that they haven’t been able to since the onset of significant diabetic peripheral neuropathy.” One of the surprises of the study were findings that suggest that alerts were much more prevalent in static activities, like sitting at a computer, driving, or standing still.

Did patients actually use feedback from the insoles to make changes?

To find out if patients did, in fact, use feedback, one can look at the findings of the study:

• During 18 months of follow-up, the risk of developing or recurring ulcers was reduced by 71%.
• There were only four new ulcers in 32 patients receiving the intervention.
• There were 10 ulcers in six of 26 patients in the control group who wore the inserts but received no feedback.

Additionally, a pilot study in the Journal of Diabetes Science and Technology  concluded that  “users who receive at least one alert per two hours could enhance adherence to footwear over time, respond better to alert-based feedback, and better perceive the benefit of such a technology-based intervention.”

How Smart Insoles Compare to Standard Diabetic Shoes and Inserts?

The active feedback of the smart insole may be better than the conditions created by diabetic shoes and inserts. Of course, patient response to feedback is key. One advantage the smart insole may have over standard shoes and inserts is the number of office visits needed to monitor patients’ feet. Dr. Caroline Abbot, the second lead author of the study at Manchester Metropolitan University, says, “We can imagine that technologies such as this could be used for the relatively new concept of remote patient monitoring whereby communication technology-based services, in sync with smart insoles, may effectively prevent foot ulcers from occurring in the diabetic community.”

ABOUT THE AUTHOR

Jeff Oescher worked for over 6 years as an orthopedic clinical associate and case technician. He now works as a medical writer for Vohra Wound Physicians, a national wound care physician group.