|
ISRCTN
|
ISRCTN06644918
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
A randomised controlled trial of two bandages for treating venous leg ulcers
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
HTA 96/12/26
|
|
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
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Cardiovascular diseases: Varicose veins/ulcers
|
|
Participants - inclusion criteria
|
Patients with leg ulcers
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
01/10/1998
|
|
Anticipated end date
|
31/01/2002
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
400
|
|
Interventions
|
1. 4 layer bandage
2. Short stretch bandage
|
|
Primary outcome measure(s)
|
Proportion of ulcers completely healed; healing rates; costs; quality of life; recurrence rates at 12 months.
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
NIHR Health Technology Assessment Programme - HTA (UK)
|
|
Trial website
|
|
|
Publications
|
2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15382102
|
|
Contact name
|
Dr
Nicky
Cullum
|
|
Address
|
Department of Health Sciences
University of York
Alcuin College
Area 2
Seebohm Rowntree Building
Heslington
|
|
City/town
|
York
|
|
Zip/Postcode
|
YO10 5DD
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)1904 321343
|
|
Fax
|
+44 (0)1904 321383
|
|
Email
|
nac2@york.ac.uk
|
|
Sponsor
|
Department of Health (UK)
|
|
Address
|
Quarry House
Quarry Hill
|
|
City/town
|
Leeds
|
|
Zip/Postcode
|
LS2 7UE
|
|
Country
|
United Kingdom
|
|
Email
|
Sheila.Greener@doh.gsi.gov.uk
|
|
Sponsor website:
|
http://www.dh.gov.uk/en/index.htm
|
|
Date applied
|
25/04/2003
|
|
Last edited
|
14/07/2008
|
|
Date ISRCTN assigned
|
25/04/2003
|
