VenUS 6 Compression therapies for treatment of venous leg ulcers V1.0

• Research type

  Research Study

• Full title

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

• IRAS ID

  280987

• Contact name

  Jo Dumville

• Contact email

  jo.dumville@manchester.ac.uk

• Sponsor organisation

  Manchester University NHS Foundation Trust

• Duration of Study in the UK

  3 years, 11 months, 31 days

• Research summary

  Summary of Research

  Venous leg ulcers are common, recurring open wounds on the lower leg. Compression is the first line of treatment for venous leg ulcers. A range of compression treatments such as four layer bandages two layer hosiery, two layer bandages and compression wraps are regularly used in the NHS. We are conducting this study because we are unsure whether one compression treatment is more effective at treating venous leg ulcers than others. To find the answer to this question, VenUS 6 will recruit and gather important information from a large number of people with a venous leg ulcer(s).

  Patients aged 18 years or older, with at least once venous leg ulcer, who are able to tolerate full compression will be invited to take part. Patients who agree to take part will receive one of the three treatments, selected at random using a computer system. This means having an equal chance of receiving one of the compression treatments under investigation, in the same way that tossing a coin gives an equal chance of getting ‘heads’ or ‘tails’. We will compare what happens to the three groups over 12 months including: how long it takes an ulcer to heal, if an ulcer reoccurs and how much treatments cost. During the trial we will also ask participants to complete questionnaires, sent via post, at 1, 3, 6 and 12 months to compare quality of life, ulcer related pain, adherence to the allocated treatment and ease of treatment use.

  Summary of Results
  Key Findings

  VenUS 6 recruited 637 patients, who were equally and randomly assigned to be offered compression wraps, two-layer bandage or evidence-based compression (four-layer bandage or two-layer hosiery). The study assessed which treatment was best for treating and healing venous leg ulcers. We collected information from participants on their general health and their ulcer.

  We found:
  • Compared with evidenced based compression (four-layer bandage or two-layer hosiery) and the two layer bandage, compression wraps increase the time it takes for venous leg ulcers to heal.
  • The time to heal a venous leg ulcer was similar when two-layer bandage and evidence-based compression was used.
  • Participants’ health-related quality of general health was similar in each of the groups.
  • When we combined all the available information for the compression therapies tested in VenUS 6, evidence-based compression was most likely to be the best use of NHS money.
  • Participants liked that they could loosen the compression wraps if they found them uncomfortable or remove them at night, although this may reduce the amount of compression that is delivered. Some participants found two-layer hosiery was difficult to apply while bandages were bulky to wear.
  The results of this study mean that patients and doctors will be able to make more informed decisions about which type of compression to use when treating a venous leg ulcer.
  

• REC name

  West of Scotland REC 4

• REC reference

  20/WS/0121

• Date of REC Opinion

  15 Sep 2020

• REC opinion

  Further Information Favourable Opinion