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
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.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