Diabetic Foot Ulcer (DFU) Prevention

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.

LOMIS Project

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.

What Patients Say about LOMIS?