Treatment with doxycycline to promote the healing of chronic venous ulcer and markers of chronic venous insufficiency
| ISRCTN | ISRCTN28389872 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28389872 |
| Secondary identifying numbers | N0013146069 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 02/02/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Prof Kevin Burnand
Scientific
Scientific
Guy's and St Thomas' NHS Foundation Trust
General, Vascular and Colorectal Surgery Department
F01 North Wing
St Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom
| Phone | +44 (0)20 7188 2570 |
|---|---|
| Kevin.burnand@kcl.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 contact details to request a participant information sheet |
| Scientific title | Treatment with doxycycline to promote the healing of chronic venous ulcer and markers of chronic venous insufficiency: a randomised controlled trial |
| Study hypothesis | 1. Is haemosiderin a reliable marker for venous insufficiency? 2. Does the inhibition of matrix metalloproteinase play any role in the healing of ulcer? |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Cardiovascular: Venous ulcers |
| Intervention | Patients will be randomised into either treatment or control group. Each group will be matched according to ulcer size. The treatment group will take two daily 100mg of doxycycline and the patients in the control group will take matched placebo tablets. A biopsy from the ulcer will be obtained before the start of the study and at 8 weeks. Sample will be used to determine the Matrix Metalloproteinase (MMPs) level. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Haemosiderin |
| Primary outcome measure | Ulcer sizes, complete or incomplete healing |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/09/2003 |
| Overall study end date | 01/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 60 patients will be recruited from the venous ulcer out patients clinic at St Thomas' Hospital |
| Participant inclusion criteria | Not provided at time of registration |
| Participant exclusion criteria | Not provided at time of registration |
| Recruitment start date | 01/09/2003 |
| Recruitment end date | 01/12/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Guy's and St Thomas' NHS Foundation Trust
London
SE1 7EH
United Kingdom
SE1 7EH
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Guy's and St. Thomas' NHS Foundation Trust (UK)
No information available
Own Account - NHS R&D Support Funding
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 |
Editorial Notes
02/02/2017: No publications found, verifying study status with principal investigator.
