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ISRCTN
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ISRCTN71578179
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ClinicalTrials.gov identifier
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Public title
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Ultrasonic assisted debridement in venous leg ulcer. A randomised controlled trial.
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0013154714
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Study hypothesis
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Utilizing ultrasound to debride chronic leg ulcer. Will this improve chronic leg ulcer healing and avoid a possible painful sharp debridement?
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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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200 patients who suffer from venous leg ulcer will be recruited from the ulcer clinic.
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Participants - exclusion criteria
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Does not match inclusion criteria
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Anticipated start date
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01/05/2004
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Anticipated end date
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01/05/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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200
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Interventions
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This is a randomised controlled trial comparing conventional compression bandage regime alone and with the addition of a maximum of 3 sessions of ultrasonic treatment before applying the compression bandages. Suitable patients will be recruited and matched to a control. Assessment will be taken a different interval up to one year to detect any difference.
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Primary outcome measure(s)
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Ulcer sizes, complete or incomplete healing.
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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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Guy's and St. Thomas' NHS Foundation Trust (UK) - NHS R&D Support Funding
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Trial website
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Publications
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Contact name
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Prof
Kevin
Burnand
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Address
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Guy's and St Thomas' NHS Foundation Trust
General, Vascular and Colorectal Surgery Department
F01 North Wing
St Thomas' Hospital, Lambeth Palace Road
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City/town
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London
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Zip/Postcode
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SE1 7EH
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Country
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United Kingdom
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Tel
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+44 (0)20 7188 2570
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Fax
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+44
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Email
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Kevin.burnand@kcl.ac.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2005
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Last edited
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25/06/2010
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Date ISRCTN assigned
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30/09/2005
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