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VenUS IV: Compression hosiery versus compression bandaging in the treatment of venous leg ulcers
ISRCTN ISRCTN49373072
DOI 10.1186/ISRCTN49373072
ClinicalTrials.gov identifier
EudraCT number
Public title VenUS IV: Compression hosiery versus compression bandaging in the treatment of venous leg ulcers
Scientific title VenUS IV: A randomised controlled trial of compression hosiery versus compression bandaging in the treatment of venous leg ulcers
Acronym VenUS IV (Venous leg Ulcer Study IV)
Serial number at source HTA 07/60/26
Study hypothesis 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.hta.ac.uk/1766
Lay summary Not provided at time of registration
Ethics approval To be submitted as of 03/03/2009.
Study design Pragmatic two-armed parallel randomised controlled multi-centre trial
Countries of recruitment United Kingdom
Disease/condition/study domain Venous leg ulcers
Participants - 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).
Participants - 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)
Anticipated start date 01/05/2009
Anticipated end date 30/04/2012
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 489
Interventions 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 measure(s) Time to ulcer healing . Total duration of follow-up: 12 months.
Secondary outcome measure(s) 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.
Sources of funding NIHR Health Technology Assessment Programme - HTA (UK)
Trial website
Publications 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24315520
Contact name Dr  Jo  Dumville
  Address Area 4, Seebohm Rowntree Building
University of York
  City/town York
  Zip/Postcode YO10 5DD
  Country United Kingdom
  Email jd34@york.ac.uk
Sponsor University of York (UK)
  Address c/o Sue Final
Innovation Centre
  City/town York
  Zip/Postcode Y010 5DD
  Country United Kingdom
  Email smf3@york.ac.uk
  Sponsor website: http://www.york.ac.uk/
Date applied 03/03/2009
Last edited 10/12/2013
Date ISRCTN assigned 17/03/2009
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