University research team ran clinical trial of smartwatch alert system
People with diabetes have been prevented from developing potentially harmful foot ulcers, cutting the risk of losing a limb, by a shoe insole system that uses smartwatch alerts to raise the alarm about dangerous levels of pressure on the skin.
Researchers at Manchester Metropolitan University tested a commercially available early warning system on clinical trial participants with diabetes who have a high risk of developing foot ulcers, and found it reduced the incidence of foot ulcers emerging or recurring by more than 70 per cent.
One of the complications of diabetes is nerve damage, known as diabetic peripheral neuropathy, with the resulting loss of sensation making it more difficult for individuals to feel when their foot is at risk of skin breakdown, often caused by friction or foreign objects in their footwear.
Foot ulcers can fail to heal and become infected over time, and may potentially lead to amputation. Up to 30 per cent of patients with a diabetic foot ulcer may go on to require some form of lower limb amputation.
Led by Neil Reeves, Professor of Musculoskeletal Biomechanics, the research team at Manchester Metropolitan University - including research fellow Dr Caroline Abbott who ran the study - equipped trial participants with shoe inserts that use ultra-thin sensors to monitor the pressure on the underside of the foot and provide feedback via a smartwatch worn on the wrist.
The smart shoe insole system used by the researchers is called the SurroSense Rx®, developed by sensor-based advanced wound care product manufacturer Orpyx Medical Technologies Inc.
Whenever the pressure sensing inserts detect clinically dangerous foot pressure, a vibratory and audio alert is transmitted wirelessly to the smartwatch prompting the device user to offload the pressure from a particular region of their foot.
These warnings allowed trial participants to learn which activities or times of day were most problematic for them – such as while driving – and which areas of their feet were the most prone to harm.
The trial volunteers could use the information to change their behaviour and immediately relieve the pressure, thereby avoiding harmful damage to their feet.
In addition to the direct feedback provided by the SurroSense Rx system, the study tracked metrics over time and generated a unique dataset for researchers to monitor compliance and understand participants' foot pressure tendencies.
Prof Reeves said: “Foot ulceration is a serious health concern for people with diabetes and a major burden for global healthcare systems.
“As part of this longitudinal clinical trial, we have shown the great potential of smart technology for reducing the incidence of foot ulcers in diabetes patients.
“Studies of this nature are very challenging, but invaluable for advancing the treatment and management of people with diabetes.”
The trial participants were patients selected due to clinical factors such as nerve damage, foot deformities and having previously suffered foot ulcers. The study involved people with both Type 1 diabetes and the more common Type 2 diabetes, which accounts for 90 to 95 per cent of cases.
At the end of the 18-month long study, the team discovered there was a 71 per cent reduction in the re-emergence of ulcers in the group using the early warning system compared to a control group without an alerting system.
Dr Breanne Everett, CEO, President and Co-Founder of Orpyx Medical Technologies Inc, said: “This critical research adds to a growing body of evidence demonstrating effectiveness of the SurroSense Rx smart insole system in reducing unnecessary foot complications in people with diabetes.
“We value the contribution by Manchester Metropolitan University in furthering research that focuses on prevention of foot complications and amputation, and improvement of mobility and quality of life, in people living with diabetes.”
The work was led by Manchester Metropolitan University in collaboration with the University of Manchester, the Manchester University NHS Foundation Trust, Lancashire Teaching Hospitals NHS Trust, the University of Miami in the United States, and Canada-based Orpyx Medical Technologies Inc.
The findings of the project were delivered to the Diabetic Foot Study Group at the meeting of the European Association for the Study of Diabetes which finished today in Berlin.
The research group was also presented at the meeting with the prestigious Paul Wilson Brand Repetitive Stress Award by the Diabetic Foot Study Group.
Prof Reeves said: “Our team of researchers and clinicians are delighted that this important work has been recognised through a prestigious clinical award.”