Condition category
Circulatory System
Date applied
17/02/2004
Date assigned
17/02/2004
Last edited
08/12/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jonathan Michaels

ORCID ID

Contact details

Sheffield Vascular Institute
Northern General Hospital
Sheffield
S5 7AU
United Kingdom
+44 (0)114 226 9124
jonathan.michaels@sth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 02/10/02

Study information

Scientific title

Acronym

VULCAN

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.

Ethics approval

North Sheffield LREC, approved in April 2004 (ref: NS2003 11 1799)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Condition

Venous ulcers

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 measures

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

Overall trial start date

01/07/2004

Overall trial end date

31/01/2010

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant 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

Recruitment start date

01/07/2004

Recruitment end date

31/01/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Sheffield Vascular Institute
Sheffield
S5 7AU
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17551425
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19939335

Publication citations

  1. Protocol

    Palfreyman S, Walker N, Venous leg ulcers and the VULCAN trial., Br J Nurs, 16, 8, 442-443.

  2. Results

    Michaels JA, Campbell WB, King BM, Macintyre J, Palfreyman SJ, Shackley P, Stevenson MD, A prospective randomised controlled trial and economic modelling of antimicrobial silver dressings versus non-adherent control dressings for venous leg ulcers: the VULCAN trial., Health Technol Assess, 2009, 13, 56, 1-114, iii, doi: 10.3310/hta13560.

Additional files

Editorial Notes