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ISRCTN
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ISRCTN55114812
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ClinicalTrials.gov identifier
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Public title
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VenUS II: larval therapy Venous Ulcer Study
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Scientific title
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Acronym
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VenUS II
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Serial number at source
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HTA 01/41/04
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Study hypothesis
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Non-healing leg ulcers are common, costly to the NHS and distressing for patients. Many leg ulcers contain slough and necrotic tissue and, whilst removal of these tissues (debridement) is widely thought to contribute to healing, direct evidence is lacking. Larval therapy has been proposed as a quick and effective debridement strategy and is increasingly used in the NHS, mainly by nurses. Larval therapy may achieve debridement more swiftly than modern wound dressings, which promote a moist environment aiding self debridement, and, unlike surgical debridement, larval therapy use is not reliant on highly trained personnel or the fitness of the patient for surgery. A further benefit of larval therapy, namely the removal of wound bacteria and Methicillin-Resistant Staphylococcus Aureas (MRSA) in particular, has been suggested, but robust evidence of this is also required. This study will establish the cost-effectiveness of larval therapy in the healing of venous and mixed arterial/venous leg ulcers; it will also assess the impact of larval therapy on wound microbiology, including MRSA, and the acceptability of the treatment for patients.
Please note that, as of 16 January 2008, the anticipated end date of this trial has been updated from 30 June 2007 to 30 April 2008.
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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 and mixed aetiology leg ulcers
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Participants - inclusion criteria
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Adults over 18 years old with leg uclers containing slough and/or necrotic tissue
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Participants - exclusion criteria
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Does not comply with inclusion criteria
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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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30/04/2008
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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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Added 10/07/08: 370 patients
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Interventions
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3 armed trial: Larval therapy (loose and bagged) and Purilon hydrogel
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Primary outcome measure(s)
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Added 10/07/08:
Time to healing of reference ulcer
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Secondary outcome measure(s)
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Added 10/07/08:
1. Time to debridement of reference ulcer
2. Health related quality of life
3. Bacterial load (including MRSA)
4. Adverse event data
5. Costs of leg ulcer treatments
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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http://www.york.ac.uk/healthsciences/centres/trials/larthe.htm
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Publications
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1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19304577
2. 2009 cost-effectiveness results in http://www.ncbi.nlm.nih.gov/pubmed/19304578
3. 2009 HTA report in http://www.ncbi.nlm.nih.gov/pubmed/19925723
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Contact name
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Prof
Nicky
Cullum
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Address
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Dept of Health Sciences
SRB (Area 2)
University of York
Heslington
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City/town
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York
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Zip/Postcode
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YO10 5DD
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Country
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United Kingdom
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Tel
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+44 (0)1904 321343
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Fax
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+44 (0)1904 321382
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Email
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nac2@york.ac.uk
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Sponsor
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University of York (UK)
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Address
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Heslington
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City/town
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York
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Zip/Postcode
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YO10 5DD
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Country
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United Kingdom
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Sponsor website:
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http://www.york.ac.uk/
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Date applied
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18/06/2004
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Last edited
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08/02/2010
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Date ISRCTN assigned
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18/06/2004
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