Title: LOad Monitoring and Intervention System (LOMIS) to prevent diabetic foot ulceration
Funder: Department of Health and Social Care

Abstract: NHS England spends &pound;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.

Lay abstract: Over 3.3 million people in the UK have diabetes and this will increase to 5 million by 2025. There are over 60,000 people with diabetic foot ulcers in England at any given time, and 160 foot ulcer related amputations every week - over 60% of these people will 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 &pound;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. When we walk, we apply pressure (compression) and forwards and backwards rubbing forces (shear) underneath our feet. It is both pressure and shear forces applied over prolonged periods of time that cause blisters or bruises. These can quickly develop into ulcers. One way to prevent foot ulcers is to alert patients when excessive loads are applied to the foot. This requires force sensors underneath the foot that can &ldquo;feel&rdquo; the load for patients who have lost their foot sensation. When &ldquo;damaging&rdquo; loads are detected, advice (for example stop walking, take a break, take the bus) can be provided through a phone-App, helping patients change their behaviour at precisely the right time. This research will develop a world-first, a 5D (5 dimensions) LOad Monitoring and Intervention System - LOMIS. It processes real time data from 3D force sensors, and detects physical activities (the 4th-dimension) over extended periods of time (the 5th dimension), to detect increased risk of foot ulcers. Alerts about ulcer risk are then communicated to patients and information provided to help them reduce risk, on the same day. A LOMIS prototype has been proven in pilot studies, demonstrating its clinical feasibility, comfort when worn and the ability to distinguish differences in foot-loading between people with and without diabetes. This project will ensure LOMIS has a patient-centred design and offers high usability. Patient and public involvement is central to all work packages, enabling people with diabetes to develop the measures of ulcer risk, the health behaviour advice given via the App, insole design, and contribute to research design and patient studies. The outcome of this project will be a LOMIS trial prototype ready for use in clinical trials to test its effectiveness in foot ulcer prevention, and ready to be commercialised into products that can be adopted by the NHS for real patient benefit.

Research activity codes: 4.1 DISCOVERY AND PRECLINICAL TESTING OF MARKERS AND TECHNOLOGIES;3.2 INTERVENTIONS TO ALTER PHYSICAL AND BIOLOGICAL ENVIRONMENTAL RISKS
Health categories: METABOLIC AND ENDOCRINE;SKIN