Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jo Dumville

ORCID ID

Contact details

Area 4
Seebohm Rowntree Building
University of York
York
YO10 5DD
United Kingdom
jd34@york.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 07/60/26

Study information

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)

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

Ethics approval

To be submitted as of 03/03/2009.

Study design

Pragmatic two-armed parallel randomised controlled multi-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Venous leg ulcers

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

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

01/05/2009

Overall trial end date

30/04/2012

Reason abandoned

Eligibility

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).

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

489

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

01/05/2009

Recruitment end date

30/04/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Area 4, Seebohm Rowntree Building
York
YO10 5DD
United Kingdom

Sponsor information

Organisation

University of York (UK)

Sponsor details

c/o Sue Final
Innovation Centre
York
Y010 5DD
United Kingdom
smf3@york.ac.uk

Sponsor type

University/education

Website

http://www.york.ac.uk/

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24315520
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25242076

Publication citations

  1. Results

    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.

  2. Results

    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.

Editorial Notes