Condition category
Circulatory System
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
24/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nicky Cullum

ORCID ID

Contact details

Department of Health Sciences
University of York
Alcuin College
Area 2
Seebohm Rowntree Building
Heslington
York
YO10 5DD
United Kingdom
+44 (0)1904 321343
nac2@york.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 96/12/26

Study information

Scientific title

Acronym

Study hypothesis

Compression bandaging is the mainstay of venous leg ulcer treatment, however the optimal bandage regimen is unclear and there are large variations in practice. The 4 layer bandage (4LB) is used widely in the UK but is discarded after a single use and is relatively expensive. The short-stretch bandage (SSB) id the standard bandage in Europe, and is reusable. A recent systematic review demonstrated the paucity of RCTs in this area, and those that exist are of poor quality. The review also showed that multilayer bandaging is more effective than single layer; high compression systems such as the 4LB and SSB are more effective than low compression systems; however the two trials that have compared SSB and 4LB were vastly underpowered and did not incorporate an economic analysis. This study proposes to compare the 4LB and SSB systems in a two-arm pragmatic RCT involving 400 patients with venous ulcers. Patients will be followed up until healing or for a maximum period of 30 months.
Substantial benefits to the NHS and patients will occur if the trial demonstrated one of the bandages is superior to the other; substantial resource savings would occur in bandage expenditure if it were shown that the SSB was of at least equivalent effectiveness to the 4LB.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Varicose veins/ulcers

Intervention

1. 4 layer bandage
2. Short stretch bandage

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Proportion of ulcers completely healed; healing rates; costs; quality of life; recurrence rates at 12 months.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/1998

Overall trial end date

31/01/2002

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with leg ulcers

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/10/1998

Recruitment end date

31/01/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Health Sciences
York
YO10 5DD
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

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

2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15382102

Publication citations

  1. Results

    Nelson EA, Iglesias CP, Cullum N, Torgerson DJ, , Randomized clinical trial of four-layer and short-stretch compression bandages for venous leg ulcers (VenUS I)., Br J Surg, 2004, 91, 10, 1292-1299, doi: 10.1002/bjs.4754.

Additional files

Editorial Notes