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 | https://doi.org/10.1186/ISRCTN72485131 |
| Protocol serial number | HTA 02/10/02 |
| Sponsor | Department of Health (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- Submission date
- 17/02/2004
- Registration date
- 17/02/2004
- Last edited
- 08/12/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Jonathan Michaels
Scientific
Scientific
Sheffield Vascular Institute
Northern General Hospital
Sheffield
S5 7AU
United Kingdom
| Phone | +44 (0)114 226 9124 |
|---|---|
| jonathan.michaels@sth.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study acronym | VULCAN |
| Study objectives | 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(s) | North Sheffield LREC, approved in April 2004 (ref: NS2003 11 1799) |
| Health condition(s) or problem(s) studied | 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 |
| 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 |
| Key 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 |
| Completion date | 31/01/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 300 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/07/2004 |
| Date of final enrolment | 31/01/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Sheffield Vascular Institute
Sheffield
S5 7AU
United Kingdom
S5 7AU
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2009 | Yes | No | |
| Protocol article | protocol | 01/04/2007 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
