VenUS III: Ultrasound for venous leg ulcers
| ISRCTN | ISRCTN21175670 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21175670 |
| Secondary identifying numbers | HTA 02/37/03 |
- Submission date
- 06/06/2005
- Registration date
- 09/06/2005
- Last edited
- 21/07/2011
- 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
Not provided at time of registration
Contact information
Dr Elizabeth Andrea Nelson
Scientific
Scientific
School of Healthcare
Baines Wing
University of Leeds
Leeds
LS2 9JT
United Kingdom
| Phone | +44 (0)113 3431373 |
|---|---|
| E.A.Nelson@leeds.ac.uk |
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 |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | VenUS III |
| Study hypothesis | Low dose ultrasound will accelerate the healing of 'hard to heal' venous leg ulcers used in addition to compression bandaging |
| Ethics approval(s) | Added 21 August 2008: Favourable ethics review provided by York Research Ethics Committee (UK) on 04/02/2005 (Ref 05/Q1108/3). |
| Condition | Venous ulcers |
| Intervention | Low dose ultrasound administered weekly for 12 weeks, for between 5 and 10 minutes using in conjunction with compression therapy versus compression therapy alone. |
| Intervention type | Other |
| Primary outcome measure | Time to complete healing of all ulcers. |
| Secondary outcome measures | 1. Proportion of patients with all ulcers healed at 24 weeks 2. Costs of healing ulcers 3. Health related quality of life 4. 12 month recurrence rate |
| Overall study start date | 01/05/2005 |
| Overall study end date | 30/10/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 336 |
| Participant inclusion criteria | People with venous ulcers treated in community or hospital out-patients with venous ulcers defined as hard to heal based on their being larger than 5 cm^2 or of greater than 6 months duration (or both). Able and willing to give informed written consent. |
| Participant exclusion criteria | Active infection in the ulcer, presence of shrapnel or joint replacements near ulcerated area; allergy to ultrasound transmission gel. |
| Recruitment start date | 01/05/2005 |
| Recruitment end date | 30/10/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
School of Healthcare
Leeds
LS2 9JT
United Kingdom
LS2 9JT
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
| Sheila.Greener@doh.gsi.gov.uk | |
| Website | http://www.dh.gov.uk/en/index.htm |
"ROR" |
https://ror.org/03sbpja79 |
Funders
Funder type
Government
NIHR Health Technology Assessment Programme - HTA (UK)
No information available
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/01/2006 | Yes | No | |
| Results article | results | 01/05/2009 | Yes | No | |
| Results article | results | 01/03/2011 | Yes | No | |
| Results article | results | 08/03/2011 | Yes | No |
