NIHR201315 – LOad Monitoring and Intervention System to prevent diabetic foot ulceration
“Built upon a novel pressure and shear sensor innovation, LOMIS is a step change wearable solution aimed to help prevent diabetic foot ulcerations in actively daily living environment. It is important for us to take a user-centred approach to ensure patients benefit.”
Over 3.3 million people in the UK have diabetes and this will increase to 5 million by 2025. Currently, there are over 60,000 people with diabetic foot ulcers in England at any given time, and 160 foot ulcer related amputations every week – sadly over 60% of these people may die within five years of amputation. Yet, 80% of foot ulcers may be preventable by better management of the forces applied to the sole of the foot. Currently, the NHS spends around £1.13 billion every year on diabetic foot ulcer-related care. Prevention is predominantly through scheduled foot screening every 3, 6, or 12 months and patient education.
However, a foot ulcer can occur quickly, even within a day. People with diabetes often cannot feel foot pain and so fail to recognise the early warning signs. Therefore, ulcers often go unnoticed and untreated, and risk of amputation is increased. Despite significant technological and clinical effort in the past few decades, effective prevention of DFU is still an unmet need for people with diabetes.
Load Monitoring and Intervention system (LOMIS) is an instrumented insole system incorporating novel three directional force sensors to monitor real time pressure and shear forces under the foot and physical activity profiles over time. This allows real-time assessment of the 5 dimensions (5D) of load associated with DFU risk. These 5D personalised profiles are connected to an App and/or a wearable device that advises patients to change behaviour in a timely manner to minimise the risk of ulceration.
Excessive pressure (e.g. compression) and shear (e.g. rubbing) forces are the 3D forces exerted repetitively on vulnerable tissues under the foot during physical activities, which are known to cause DFUs. State-of-the-art systems only measure/manage compression pressure, whereas shear forces are critical in the cause of ulceration. Furthermore, the compression/shear loads generated by different activities of daily living e.g. walking, stair-climbing etc. (activity is a 4th-dimension to the DFU problem) are also important factors influencing DFU risk. Over weeks and months, time being the 5th dimension, plantar tissues can change physiological status and load tolerance e.g. due to deformity and conditioning.
LOMIS is first of its kind wearable prevention solution which measures and interpret all five-dimensions simultaneously (particularly direct measurement of the shear forces applied to the sole of the foot) and connect this with real world health behaviour strategies via a health behaviour App.
The LOMIS project is a 3-year project funded by the NIHR Invention for Innovation (i4i) programme. This project combines multidisciplinary expertise from the University of Southampton and University of Salford, supported by a Clinical Advisory Group, Public, Patient Involvement and Engagement (PPIE) panel to ensure a comprehensive user-centred design and development.
“Why is LOMIS so important to me?
Diabetic foot ulceration affects not only your foot. The mental impact of ulceration can be very restrictive limiting or even stopping people doing the activities they once did and love for fear of ulceration and the potential for amputation if this ulcer progresses.
As someone who has experienced ulceration on several occasions LOMIS would give me a safety net or early warning system allowing me to partake in the activities I want to do without the mental stress of ‘is my foot ulcerating?’ ”
Mr. Andy Lavender
“As a diabetic of over twenty years, good foot health is so incredibly important to me, it allows me to enjoy a full and active lifestyle. Having healthy skin, nails and wearing the right footwear enables me to take part in all the activities I enjoy, from running to playing tennis. Quite simple a good foot health regime for me helps prevents serious damage to nerves , blood flow and circulation leading to the extreme risk of an amputation.
LOMIS would help me to get into a good habit and I certainly want to continue to have a full and active lifestyle for many years to come.”
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*The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.