Superficial venous surgery in the treatment of venous ulcers and the prevention of recurrence
| ISRCTN | ISRCTN55254723 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55254723 |
| Protocol serial number | N0226118474 |
| Sponsor | Department of Health (UK) |
| Funder | South Manchester University Hospitals NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 14/07/2008
- 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 Charles Nevin McCollum
Scientific
Scientific
Academic Department of Surgery
South Manchester University Hospitals NHS Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
| Phone | +44 0161 291 5853 (Barbara) |
|---|---|
| CNMCC@man.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | In addition to the role of superficial venous surgery (SVS) in venous ulcer healing and recurrence, to identify patients at risk for venous ulceration and to establish a role for SVS in the prevention of venous ulceration. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular: Venous ulcer |
| Intervention | Surgery to take place within 4 weeks of randomisation. |
| Intervention type | Other |
| Primary outcome measure(s) |
Improvement in venous function. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/06/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 32 |
| Key inclusion criteria | Patients divided into three groups: Patients with venous ulcers attending the vascular clinic at SMUHT Patients with venous insufficiency, and no previous ulceration Patients with venous insufficiency, and previous ulceration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/07/2002 |
| Date of final enrolment | 30/06/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Academic Department of Surgery
Manchester
M23 9LT
United Kingdom
M23 9LT
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 | 01/09/2005 | Yes | No |
