LOMIS - Development of a 5D Load Monitoring and Intervention System
Research type
Research Study
Full title
Development of a 5 dimensions Load Monitoring and Intervention System (LOMIS) to monitor forces under the foot and physical activity profiles over time in a real-world setting which is capable of notifying service users of potentially high-risk activities.
IRAS ID
298091
Contact name
Daniel Parker
Contact email
Sponsor organisation
The University of Salford
Duration of Study in the UK
1 years, 7 months, 12 days
Research summary
Research Summary
This project aims to develop a world-first, five dimensions 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 in a real-world setting, which could assist in identifying and assessing harmful activities for minimizing the risk of diabetic foot ulceration (DFU). Following development LOMIS may also provide real-time and retrospective data to the service users and clinicians/researchers using a simple mobile application to notify them of potentially high-risk activities.
The study will be a three-phase trial, and patient and public involvement is central to the development of this system. In LOMIS Study 1, which is a laboratory study, the feasibility, safety, usability, validity, and reliability of LOMIS for measuring foot plantar loading and physical activity will be assessed in a sample of 30 people with diabetes (PWDs) over a maximum of 2.5 hours.
LOMIS Study 2 is a pilot of a longitudinal study and will follow a minimum 5 PWDs during 5 consecutive days using the LOMIS. Participants will be monitored to investigate whether LOMIS is valid, safe, and usable in the more extended period of time.
LOMIS Study 3 is a longitudinal study to assess the system functionality, feasibility, validity, durability, safety, and usability of LOMIS in real-world use and provide data to develop 5D risk metrics. 50 PWDs classified as moderate and high risk (but no current ulceration) will be recruited across NHS centers to use the LOMIS for 3-12 months. New ulceration and other critical clinical episodes will be recorded to inform 5D risk models. Participants will be very closely monitored throughout this trial.
An interview will be conducted in all three phases to understand the participants' and clinicians' perspectives and opinions about LOMIS.Summary of Results
There are over 3.3 million people in the UK living with diabetes, and this number is projected to reach 5.5 million by 2030. Over 75,000 people in England have active foot ulceration at any given time, contributing to more than 5,600 amputations each year. Over 50% of people who have an amputation following a foot ulcer will pass away within five years. Current prevention primarily involves scheduled foot screenings every 3, 6, or 12 months and patient education. However, a foot ulcer can develop quickly, often within a day.
When we walk, we apply pressure (compression) and forward-backwards rubbing forces (shear) under our feet. Both pressure and shear forces, when sustained over prolonged periods, can 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 under the foot that can “sense” the load for patients who have lost foot sensation. When "damaging" loads are detected, advice (e.g., stop walking, take a break, or use public transport) can be provided.This research involves developing the world’s first Load Monitoring and Intervention System (LOMIS). It processes real-time data from 3-directional force sensors embedded in shoes to detect excessive load and physical activities over time. This data analysis helps identify increased and personalised risk of foot ulcers, which can then be promptly communicated to patients for self-management.
A patient-centred design approach has been implemented, integrating patient and public involvement throughout the project to ensure LOMIS functionality and user acceptance. The developed LOMIS prototype has been successfully used by over 80 patients at home and some have used it for up to 3 months, demonstrating its potential safety, regulatory compliance, and acceptance by a diverse range of users and the NHS.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
21/WM/0239
Date of REC Opinion
6 Dec 2021
REC opinion
Further Information Favourable Opinion