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ISRCTN
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ISRCTN28389872
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ClinicalTrials.gov identifier
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Public title
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Treatment with doxycycline to promote the healing of chronic venous ulcer and markers of chronic venous insufficiency. 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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N0013146069
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Study hypothesis
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1. Is haemosiderin a reliable marker for venous insufficiency?
2. Does the inhibition of matrix matalloproteinase play any role in the healing of ulcer?
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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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Cardiovascular: Venous ulcers
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Participants - inclusion criteria
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Not provided at time of registration
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/09/2003
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Anticipated end date
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01/12/2007
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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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60 patients will be recruited from the venous ulcer out patients clinic at St Thomas' Hospital.
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Interventions
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Patients will be randomised into either treatment or control group. Each group will be matched according to ulcer size. The treatment group will take 2 daily 100mg of doxycycline and the patients in the control group will take matched placebo tablets. A biopsy from the ulcer will be obtained before the start of the study and at 8 weeks. Sample will be used to determine the (Matrix Metalloproteinase) MMPs level.
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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)
Own Account - 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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07/04/2011
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Date ISRCTN assigned
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30/09/2005
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