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ISRCTN
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ISRCTN97621126
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DOI
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10.1186/ISRCTN97621126
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Does venous surgery improve healing and minimise recurrence of venous ulcers?
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Scientific title
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Acronym
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USABLE
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Serial number at source
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G0000328
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Study hypothesis
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To investigate whether simple venous surgery improves the clinical and cost-effectiveness of four layer bandaging for venous ulcers in terms both healing and recurrence.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Venous ulcers
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Participants - inclusion criteria
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Venous ulcers associated with venous abnormality (superficial vein incompetence, with or without incompetent perforators, with or without deep vein incompetence, suitable for simple surgical correction, with or without perforating vein surgery [as shown by colour duplex scanning])
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Participants - exclusion criteria
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1. Ankle Brachial Pressure Index (ABPI) less than 0.8
2. Intolerant to compression bandaging
3. Less than six months to live
4. Deep vein occlusion surgery and compression versus compression only
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Anticipated start date
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01/06/2001
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Anticipated end date
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28/02/2006
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Status of trial
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Stopped |
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Patient information material
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Target number of participants
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1000
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Interventions
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1. Compression bandaging plus venous surgery
2. Compression bandaging alone
Trial closed early on 15/01/03 on feasibility grounds.
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Primary outcome measure(s)
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1. Proportion of ulcers completely healed
2. Proportion of ulcers recurring
3. Ulcer healing rate
4. Quality of life
5. Costs
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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Contact name
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Mr
Alun
Davies
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Address
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Department of Vascular Surgery
Charing Cross Hospital
Fulham Palace Road
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City/town
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London
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Zip/Postcode
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W6 8RF
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Country
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United Kingdom
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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18/10/2000
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Last edited
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29/07/2009
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Date ISRCTN assigned
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18/10/2000
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