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Randomised controlled trial (RCT) and economic modelling to evaluate the place of anti-microbial agents in the management of venous leg ulcers
ISRCTN ISRCTN72485131
DOI 10.1186/ISRCTN72485131
ClinicalTrials.gov identifier
EudraCT number
Public title Randomised controlled trial (RCT) and economic modelling to evaluate the place of anti-microbial agents in the management of venous leg ulcers
Scientific title
Acronym VULCAN
Serial number at source HTA 02/10/02
Study hypothesis Are anti-microbial treatments for venous leg ulcers cost-effective?

Please note that, as of 16/01/2008, the start and anticipated end date of this trial have been updated from 01/04/2004 and 31/03/2007 to 01/07/2004 and 31/07/2008, respectively.

Please note that, as of 27/08/2009, the anticipated end date of this trial has been updated from 31/07/2008 to 31/01/2010.

Please note that the target number of participants was added as of 07/09/2009.
Lay summary
Ethics approval North Sheffield LREC, approved in April 2004 (ref: NS2003 11 1799)
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Venous ulcers
Participants - inclusion criteria Current inclusion criteria as of 07/09/2009:
Patients with an unhealed venous leg ulcer that had been present for longer than 6 weeks.

Inclusion criteria provided at time of registration:
Patients with an unhealed venous leg ulcer.
Participants - exclusion criteria Added as of 07/09/2009:
1. Refusal to give informed consent to participating in the RCT
2. Insulin controlled diabetes mellitus
3. Pregnancy
4. Sensitivity or specific contra-indications to the use of silver
5. Ankle/brachial pressure index of less than 0.8 in the affected leg
6. Leg ulcers with a maximum diameter of less than one centimetre
7. Atypical ulcers, including those where there was suspicion of malignancy, co-existing skin conditions, or vasculitis
8. Patients on oral or parenteral antibiotic treatment
Anticipated start date 01/07/2004
Anticipated end date 31/01/2010
Status of trial Completed
Patient information material For RCT: http://www.shef.ac.uk/content/1/c6/06/48/22/Info%20sheet.pdf. For observation group: http://www.shef.ac.uk/content/1/c6/06/48/22/obsMay05.pdf
Target number of participants 300
Interventions RCT group:
One group will have a standard non-adherent dressing applied beneath compression bandages. The other will have an anti-microbial dressing applied beneath compression bandages.

Added as of 08/09/2009:
Those patients (n= 91) who were not eligible or did not wish to take part in the RCT were invited to participate in the observational arm of the study. In this arm the treatment was entirely at the discretion of the responsible clinician and the patient. However, information about the dressing, outcomes and subsequent clinical assessments followed the protocol for the randomised trial.
Primary outcome measure(s) Current primary outcome measures as of 08/09/2009:
1. Number of ulcers completely healed at 12 weeks
2. Cost data from the RCT and observation arms at 12 weeks

Information provided at time of registration:
1. Cost data will be collected from the observational database and RCT
2. Clinical end point for the RCT group: time to complete healing of the leg ulcer
Secondary outcome measure(s) Current information as of 08/09/2009:
1. Recurrence rate at six months and one year
2. Quality of life (SF-36® Health Survey, Euroqol EQ-5D and Standard Gamble [SG]) at 1, 3, 6 and 12 months
3. Symptomatic data (including pain) collected weekly until 12 weeks or ulcer healed

Information provided at time of registration:
1. Recurrence rate
2. Quality of life (SF-36® Health Survey, Euroqol EQ-5D and Standard Gamble [SG])
3. Symptomatic measures, including pain
Sources of funding NIHR Health Technology Assessment Programme - HTA (UK)
Trial website
Publications 1. 2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17551425
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19939335
Contact name Prof  Jonathan  Michaels
  Address Sheffield Vascular Institute
Northern General Hospital
  City/town Sheffield
  Zip/Postcode S5 7AU
  Country United Kingdom
  Tel +44 (0)114 226 9124
  Fax +44 (0)114 261 0112
  Email jonathan.michaels@sth.nhs.uk
Sponsor Department of Health (UK)
  Address Quarry House
Quarry Hill
  City/town Leeds
  Zip/Postcode LS2 7UE
  Country United Kingdom
  Email Sheila.Greener@doh.gsi.gov.uk
  Sponsor website: http://www.dh.gov.uk/en/index.htm
Date applied 17/02/2004
Last edited 08/12/2009
Date ISRCTN assigned 17/02/2004
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