A study to investigate the Effect of Surgery and Compression on Healing And Recurrence in chronic venous ulceration
| ISRCTN | ISRCTN07549334 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07549334 |
| Secondary identifying numbers | 00PRT/6 |
- Submission date
- 28/02/2007
- Registration date
- 13/04/2007
- Last edited
- 13/06/2007
- 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
Mr Keith Poskitt
Scientific
Scientific
Department of Vascular Surgery
Cheltenham General Hospital
Sandford Road
Cheltenham
GL53 7AN
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | ESCHAR |
| Study hypothesis | The surgical correction of superficial venous surgery in addition to compression reduces venous ulcer recurrence in comparison to compression therapy alone. |
| Ethics approval(s) | Approval received from Gloucestershire Local Research Ethics Committee on the 29th January 1998 (ref: 98/44E). |
| Condition | Chronic venous ulceration |
| Intervention | Two groups were randomised to either compression therapy alone or compression plus superficial venous surgery. |
| Intervention type | Other |
| Primary outcome measure | 1. Ulcer healing 2. Ulcer recurrence |
| Secondary outcome measures | Ulcer free time |
| Overall study start date | 01/01/1999 |
| Overall study end date | 01/08/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 500 |
| Participant inclusion criteria | Open or recently healed leg ulceration (within six months) of greater than four weeks duration between knee and malleoli, with Ankle Brachial Pressure Index (ABPI) above 0.85 and duplex evidence of superficial with or without deep venous reflux. |
| Participant exclusion criteria | 1. Duplex imaging not possible 2. Patient unable/unwilling to give informed consent 3. Deep venous occlusion 4. Unfit for surgery (even under local anaesthetic) 5. Multilayer compression therapy not practical 6. Malignant ulceration |
| Recruitment start date | 01/01/1999 |
| Recruitment end date | 01/08/2002 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Vascular Surgery
Cheltenham
GL53 7AN
United Kingdom
GL53 7AN
United Kingdom
Sponsor information
South West NHS R&D Directorate (UK)
Government
Government
Whiteladies Road
Bristol
BS8 2PR
United Kingdom
Funders
Funder type
Research council
Medical Research Council (UK) - interim grant
No information available
South West NHS R&D Directorate (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? |
|---|---|---|---|---|---|
| Results article | Results () | 05/06/2004 | Yes | No | |
| Results article | Long term results () | 14/07/2007 | Yes | No |
