Dr Jo Dumville
Seebohm Rowntree Building
University of York
VenUS IV: a randomised controlled trial of compression hosiery versus compression bandaging in the treatment of venous leg ulcers
VenUS IV (Venous leg Ulcer Study IV)
Venous leg ulcers are treated with compression to promote healing. An evidence-based compression treatment is 4-layer bandaging however, compression hosiery may offer advantages over this treatment. The trial aims to assess the clinical and cost effectiveness of compression hosiery compared with 4 layer bandaging in terms of ulcer healing and quality of life in venous leg ulcer patients.
More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/076026
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0004/51907/PRO-07-60-26.pdf
Not provided at time of registration – submission pending
Pragmatic two-armed parallel randomised controlled multi-centre trial
Primary study design
Secondary study design
Randomised parallel trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Venous leg ulcers
The participants will be randomly allocated to the following two arms (randomisation ratio 1:1):
Intervention group: Compression hosiery
Control group: Four-layer bandaging
Interventions will be received for as long as required i.e. until healing or cessation of trial treatment for another reason. Total duration of follow-up is 12 months.
Primary outcome measures
Time to ulcer healing . Total duration of follow-up: 12 months.
Secondary outcome measures
1. Cost of treatments. Total duration of follow-up: 12 months.
2. Quality of life (QOL), assessed by SF-12® Health Survey, Euroqol EQ-5D, and Venous Insufficiency Epidemiological and Economic Study (VEINES)-QOL questionnaire every 3 months for 12 months
3. Patient concordance with treatment. Any changes to treatment will be recorded by nurses throughout the trial (Total duration of follow-up: 12 months). At 1 month, a postal questionnaire will be sent to participants in the intervention group to collect data on how often they wear the hosiery.
4. Recurrence. Total duration of follow-up: 12 months.
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Both males and females, aged18 years or over
2. Patient has at least one venous leg ulcer*
3. Patient has an ankle brachial pressure index (ABPI) equal to or greater than 0. 8 and <1.2 (taken within last 3 months)
4. Patient is able and willing to tolerate high compression
*For the purpose of this study a leg ulcer will be considered as any break in the skin on the leg (below the knee and above the malleoli) which as either (a) been present for more than six weeks or (b) occurs in a person with a history of venous leg ulceration. A participant will be considered to have a purely venous leg ulcer where clinically no other aetiology is suspected. Clinical history must be considered and the study participant must have an ABPI of equal to or greater than 0.8. The ulcer must also be venous in appearance (i.e. moist, shallow, irregular shape, venous eczema, ankle oedema).
Target number of participants
Participant exclusion criteria
1. Leg ulcer of non-venous aetiology (i.e. arterial)
2. Wound exudate levels too high for the use of compression hosiery (nurse judgement)
3. Patient has very bony prominences at risk of pressure damage
4. Patients are unable or do not wish to consent to participation in the trial
5. Patients are currently in another study evaluating treatments for their leg ulcer
6. Known allergy to any trial product
7. Patient has previously been in this trial
8. People with diabetes mellitus whose blood sugar not well controlled (HbA1c greater than 10% taken within the last three months). (Patients with well controlled diabetes HbA1c less than or equal to 10% are eligible for the trial)
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
University of York
NIHR Health Technology Assessment Programme - HTA (UK)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Ashby RL, Gabe R, Ali S, Adderley U, Bland JM, Cullum NA, Dumville JC, Iglesias CP, Kang'ombe AR, Soares MO, Stubbs NC, Torgerson DJ, Clinical and cost-effectiveness of compression hosiery versus compression bandages in treatment of venous leg ulcers (Venous leg Ulcer Study IV, VenUS IV): a randomised controlled trial., Lancet, 2014, 383, 9920, 871-879, doi: 10.1016/S0140-6736(13)62368-5.
Ashby RL, Gabe R, Ali S, Saramago P, Chuang LH, Adderley U, Bland JM, Cullum NA, Dumville JC, Iglesias CP, Kang'ombe AR, Soares MO, Stubbs NC, Torgerson DJ, VenUS IV (Venous leg Ulcer Study IV) - compression hosiery compared with compression bandaging in the treatment of venous leg ulcers: a randomised controlled trial, mixed-treatment comparison and decision-analytic model., Health Technol Assess, 2014, 18, 57, 1-293, v-vi, doi: 10.3310/hta18570.
Bland JM, Dumville JC, Ashby RL, Gabe R, Stubbs N, Adderley U, Kang'ombe AR, Cullum NA, Validation of the VEINES-QOL quality of life instrument in venous leg ulcers: repeatability and validity study embedded in a randomised clinical trial, BMC Cardiovasc Disord, 2015 , 15, 85, doi: 10.1186/s12872-015-0080-7.