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

Trial Status: Open

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 ÔheadsÕ or ÔtailsÕ. 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.