LOad Monitoring and Intervention System (LOMIS) to prevent diabetic foot ulceration

NHS England spends £1.13Billion annually on diabetic foot care (~1% of the entire NHS budget) and 80% of foot ulcer related lower-limb amputations are preventable.

Yet currently there is no practical solution that enables patients to prevent diabetic foot ulceration (DFU) by changing physical activity during everyday living.

This project aims to develop a Load Monitoring and Intervention system (LOMIS) that uses insoles incorporating novel 3D force sensors to monitor forces under the foot and physical activity profiles over time, thus providing 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 and real world context and thus minimise 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 will measure and interpret all five-dimensions of DFU risk simultaneously, evaluate ulceration risk, and connect this with real world health behaviour strategies.

The end point of this project will be a Beta trial-prototype of LOMIS with 5D risk metrics, a health behaviour App, technical file documentation and health economic models all in place, thus a system ready for downstream randomised controlled trials (for clinical and cost-effectiveness evaluation), commercialisation and eventually NHS adoption.