BIOSVUS
Research type
Research Study
Full title
Studying mechanisms of venous ulcer progression to inform effective treatments and biomarker identification
IRAS ID
332775
Contact name
Michael Wall
Contact email
Sponsor organisation
The Dudley Group NHS Foundation Trust
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
2 years, 5 months, 31 days
Research summary
Chronic venous leg ulcers have high mortality rate and contribute a significant cost to the NHS, despite a dedicated part of the medical device industry aiming to improve these factors. Those that do live with the condition often have a poor quality of life, with the wound having a significant impact on their mobility and confidence. Further research and development is needed to reduce the impact that chronic venous leg ulcers have on the population. This study is designed to investigate biomarkers and mechanisms of chronic venous leg ulcers, as well as comparing methods of sampling these wounds. The study aims to do this by taking biopsies, wound fluid and plasma, and analysing them for lipids and inflammatory modulating proteins, such as cytokines and matrix metalloproteinases. These markers should inform better treatment pathways and improve diagnostic possibilities. Once the markers are understood, in vitro work can also be conducted to further understand the effect exerted by the specific marker, to gain a greater mechanistic understanding of the wounds. Additionally, sampling methods can be compared, and linked based on similar changes in biomarkers. By comparing the markers from different sampling techniques, it may be possible to identify some markers that can be used to link the samples together, to allow a diagnostic understanding to be obtained for the wound, by only using the linked biomarkers from the optimal sampling technique in future.
REC name
South West - Frenchay Research Ethics Committee
REC reference
24/SW/0021
Date of REC Opinion
4 Apr 2024
REC opinion
Further Information Favourable Opinion