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VENUS-6 A randomised controlled trial of compression therapies for the treatment of venous leg ulcers

Venous leg ulcers are common, open wounds that are painful and reduce health-related quality of life. These wounds are caused by damage in the leg veins which stops blood flowing properly and leads to tissue break down and poor healing. 

There are a range of treatments available for venous leg ulcers. These include four layers of bandages (called compression bandages) wrapped tightly round affected legs or two-layer hosiery (below-knee stockings). Not all people can use hosiery though so health professionals and patients together choose the best option for them. Using a suitable choice of the four-layer bandages or two-layer hosiery to treat people with venous leg ulcers is called “evidence-based compression”.

In addition to these treatments, two new compression treatments are being used in the NHS. The first is the two-layer bandage and the second is adjustable hook-and-loop-fastened compression systems (we call these compression wraps). There is a lot of interest in these treatments but we don’t know if they work as well as evidence based compression as they have not been properly tested. 

The VENUS-6 trial will compare evidence based compression (choice of four-layer bandage or two-layer compression hosiery), two-layer bandage or adjustable hook-and-loop fastened compression systems (“compression wraps” ), to see if these make any difference to how quickly venous leg ulcers heal. This will be a multi-centre randomised controlled trial where patients will receive one of these treatments. The study aims to randomise 675 participants, 225 to evidence based compression, 225 to two layer bandage, and 225 to compression wraps. The primary outcome is time to ulcer healing. The associated costs of these treatment to the NHS will also be evaluated.

The study is being run by Manchester University NHS Foundation Trust and the University of York, with funding from the National Institute for Health Research Health Technology Assessment Programme (Ref: NIHR128625). Professor Jo Dumville is the Chief Investigator.

 

Funding

Funder(s) NIHR HTA
Start Date February 2020
End Date January 2024

Members

YTU Team

External Members

  • Professor Jo Dumville – University of Manchester
  • Professor Dame Nicky Cullum - University of Manchester
  • Professor Ian Chetter – University of Hull/Hull York Medical School
  • Dr Una Adderley – University of Leeds
  • Louise O’Connor – Manchester University NHS Foundation Trust
  • Pedro Saramago Goncalves – Centre for Health Economics, University of York
  • Mr Philip Stather – Colchester Hospital University NHS Foundation Trust
  • Dr Jane Griffiths – University of Manchester
  • Dr Ross Atkinson – University of Manchester
  • Mrs Brigid Smart – University of Manchester
  • Dr Marta Soares – Centre for Health Economics, University of York
  • Nikki Stubbs – Leeds Community Healthcare NHS Trust