Does venous surgery improve healing and minimise recurrence of venous ulcers?
| ISRCTN | ISRCTN97621126 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97621126 |
| Secondary identifying numbers | G0000328 |
- Submission date
- 18/10/2000
- Registration date
- 18/10/2000
- Last edited
- 29/07/2009
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Alun Davies
Scientific
Scientific
Department of Vascular Surgery
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | USABLE |
| Study objectives | To investigate whether simple venous surgery improves the clinical and cost-effectiveness of four layer bandaging for venous ulcers in terms both healing and recurrence. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Venous ulcers |
| Intervention | 1. Compression bandaging plus venous surgery 2. Compression bandaging alone Trial closed early on 15/01/03 on feasibility grounds. |
| Intervention type | Other |
| Primary outcome measure | 1. Proportion of ulcers completely healed 2. Proportion of ulcers recurring 3. Ulcer healing rate 4. Quality of life 5. Costs |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/06/2001 |
| Completion date | 28/02/2006 |
| Reason abandoned (if study stopped) | Feasibility grounds |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1000 |
| Key inclusion criteria | Venous ulcers associated with venous abnormality (superficial vein incompetence, with or without incompetent perforators, with or without deep vein incompetence, suitable for simple surgical correction, with or without perforating vein surgery [as shown by colour duplex scanning]) |
| Key exclusion criteria | 1. Ankle Brachial Pressure Index (ABPI) less than 0.8 2. Intolerant to compression bandaging 3. Less than six months to live 4. Deep vein occlusion surgery and compression versus compression only |
| Date of first enrolment | 01/06/2001 |
| Date of final enrolment | 28/02/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Vascular Surgery
London
W6 8RF
United Kingdom
W6 8RF
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
