Monitoring wound status using multi-parameter optical fibre sensors
Research type
Research Study
Full title
Monitoring wound status using multi-parameter optical fibre sensors
IRAS ID
291141
Contact name
Frances Game
Contact email
Sponsor organisation
The University of Nottingham
ISRCTN Number
ISRCTN43662626
Duration of Study in the UK
0 years, 8 months, 28 days
Research summary
Summary of Research
Chronic wounds are defined as those that do not heal in the expected time and are a challenge to health services globally. Around 4% of the entire NHS budget is needed every year to treat chronic wounds and of these diabetic foot ulcers (DFUs) account for about a quarter of the costs. Recently interest has increased in the use of so-called “smart” wound dressings which may be able to monitor the wound status remotely and potentially alert healthcare professionals to problems before they are evident clinically.
This study is focused on the use of an optical fibre sensing system for wound monitoring (OFSSWM) to measure 5 key factors associated with chronic wound healing (humidity, temperature, carbon dioxide, pH, and ammonia) at the surface of the wound which may indicate that the wound is healing and/or deteriorating or has become infected. This could alert clinicians earlier than would currently be the case and prompt urgent review. Or if the wound is progressing well, could reduce the number of routine clinic visits.
The OFSSWM consists of an optical probe, which non-invasively interacts with the external wound micro-environment, and an opto-electronic unit, which collects and displays the information obtained by the optical probe via software for interpretation by members of the Engineering Team.
We propose to ask participants with active DFUs to attend the diabetic foot clinic on 4 separate occasions where the OFSSWM will be applied both with the participant seated and walking for a short distance. The measurements from the OFSSWM will be compared to measurements taken by more standard means. Should the condition of the wound change at any visit we hope we will be able to see whether this is reflected in any changes in the measurements taken. No other aspect of the usual care of the participants will change.
Summary of Results
We are delighted to inform the successful completion of the clinical trial “Monitoring wound status using multi-parameter optical fibre sensors”. The primary objective was to explore the feasibility of using an investigational medical device (“Optical Fibre Sensing System for Wound Monitoring”, OFSSWM) in a clinical environment. The study aimed to recruit up to 10 patients with diabetic foot ulcers and perform measurements from the wound area using the OFSSWM and commercial sensors for a maximum of 4 bi-weekly clinic visits at the study site (Florence Nightingale Community Hospital, University Hospitals of Derby and Burton, NHS Foundation Trust).
The total number of patients recruited was 10 and 38 out of 40 hospital visits performed. There were 2 patient visits cancelled due to adverse events unrelated to this study. As stated in the clinical protocol, the final visit for the final patient, i.e., Patient 10 - visit 4 (performed on March 20th 2024) marks the end of our study. We are currently analysing the obtained data and we will present the study results as described in the clinical protocol.REC name
South East Scotland REC 02
REC reference
21/SS/0050
Date of REC Opinion
28 Jun 2021
REC opinion
Favourable Opinion