| Source of record | UK Trials |
| ISRCTN | ISRCTN06644918 |
| Date ISRCTN assigned | 25/04/2003 |
| Local reference number(s) | HTA 96/12/26 |
| Public title | A randomised controlled trial of two bandages for treating venous leg ulcers |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Cardiovascular diseases: Varicose veins/ulcers |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Patients with leg ulcers |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
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| Anticipated start date | 01/10/1998 |
| Anticipated end date | 31/01/2002 |
| Status of trial | Completed |
| 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 available at registration |
| Publications | http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15382102 |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Sponsor name | Department of Health (UK) |
| Sponsor details | Quarry House
Quarry Hill
Leeds
United Kingdom
LS2 7UE |
| Sponsor email | Sheila.Greener@doh.gsi.gov.uk |
| Sponsor website | http://www.dh.gov.uk/en/index.htm |
| Contact name | Dr Nicky Cullum |
| Contact details | Department of Health Sciences
University of York
Alcuin College
Area 2
Seebohm Rowntree Building
Heslington
York
United Kingdom
YO10 5DD |
| Contact telephone | +44 (0)1904 321343 |
| Contact fax | +44 (0)1904 321383 |
| Contact email | nac2@york.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN06644918 |
| Date last extracted from ISRCTN register | 17/04/2008 |
