A randomised controlled trial of two bandages for treating venous leg ulcers

ISRCTN	ISRCTN06644918
DOI	https://doi.org/10.1186/ISRCTN06644918
Secondary identifying numbers	HTA 96/12/26

Submission date: 25/04/2003
Registration date: 25/04/2003
Last edited: 24/08/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Nicky Cullum
Scientific

Department of Health Sciences
University of York
Alcuin College
Area 2
Seebohm Rowntree Building
Heslington
York
YO10 5DD
United Kingdom

Phone	+44 (0)1904 321343
Email	nac2@york.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Varicose veins/ulcers
Intervention	1. 4 layer bandage 2. Short stretch bandage
Intervention type	Other
Primary outcome measure	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 study start date	01/10/1998
Completion date	31/01/2002

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	400
Key inclusion criteria	Patients with leg ulcers
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/10/1998
Date of final enrolment	31/01/2002

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Health Sciences

York
YO10 5DD
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone	+44 (0)1132 545 843
Email	Sheila.Greener@doh.gsi.gov.uk
Website	http://www.dh.gov.uk/en/index.htm
"ROR"	https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2004		Yes	No