Detecting risk factors early could help reduce the risk of amputation.

The re-emergence of diabetes-related foot ulcers could be prevented thanks to an early warning system powered by a smart shoe insole, according to a new study.

As part of a study, recently published in The Lancet Digital Health, researchers at Manchester Metropolitan University, The University of Manchester and Manchester Diabetes Centre, including previously DRWF-funded researcher Profsessor Neil Reeves, tested the effectiveness of an intelligent shoe insole system that tracks pressure, while providing instant feedback.

Smart insole wearers may then be prompted to adjust their behaviour or stance to alleviate or offload the kind of pressure that can cause ulcers.

The results showed that the system reduced foot ulcers returning in 70 patients participating by 71% during the 18 months study period.

It is estimated that one in every four people with diabetes will get a foot ulcer related to the condition in their lifetime and the danger is they fail to heal and become infected over time.

Around 30% of patients with a diabetes-related foot ulcer may go on to require some form of lower limb amputation as a result of complications.

Dr Caroline Abbott, Research Fellow at Manchester Metropolitan University, with the smart insole system

Dr Caroline Abbott, Research Fellow within the Research Centre for Musculoskeletal Science and Sports Medicine at Manchester Metropolitan University, study lead author, said: “This is the first clinical trial to test if ‘smart’ or ‘intelligent’ insoles, worn during daily life over a long period of time, can prevent debilitating foot ulcers from recurring in ‘high-risk’ patients with diabetes.

“We realised that any active technology that alerts patients to their daily periods of harmful high foot pressures would be a very powerful foot ulcer prevention strategy.

“The benefits of the technology are that the patients are empowered to monitor their own risk themselves and better understand their own foot pressures and then actively offload pressures during harmful periods.

“The patients with the best compliance and self-management were best protected against ulcers recurring.

“This finding illustrates the concept of the effectiveness of patient empowerment through targeted technology.”

A person using a smartwatch.

The smartwatch alerts wearers to periods of sustained high foot pressure

The smart insole system tested by the Manchester Metropolitan team is called SurroSense Rx and was developed by sensor-based advanced wound care product manufacturer Orpyx Medical Technologies Inc in Canada.

Shoe inserts were fitted with eight sensors that continually monitored and measured pressure points around the sole of the foot during the wearer’s day to day activities.

When a dangerous amount of pressure was detected, data was fed wirelessly to a companion smartwatch, to encourage the wearer to make adjustments straight away and reduce the pressure on the area of the foot affected.

This might include the patient walking around in order to spread their weight better over both feet, sitting down and removing weight from the affected foot or checking their footwear for foreign objects or excessively tight shoelaces.

Dr Abbott said: “Generally, patients reacted well to wearing the smart insole system, although some were put off by having to use digital technology per se and others by the aesthetics of the system as, in our prototype, the sensor pod is clearly visible on the top surface of the shoe.”

She added: “While these insoles are already on sale to the wider public in USA and Canada, next generation more user-friendly smart insoles are currently being developed and these should improve the wearer’s experience even further.

“Smart insoles certainly may become available on prescription for high-risk people with diabetes in the UK although it will be necessary for much larger clinical trials than ours to be conducted before NICE (the National Institute for Health and Care Excellence) could consider the economic and healthcare benefits of prescribing smart insoles to diabetics who are likely to develop foot ulcers.

“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 diabetes community.”

Read the report in The Lancet Digital Health
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