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 |
| Protocol serial number | N0013146069 |
| Sponsor | Department of Health |
| Funders | Guy's and St. Thomas' NHS Foundation Trust (UK), Own Account - NHS R&D Support Funding |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | 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 objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Haemosiderin |
| Primary outcome measure(s) |
Ulcer sizes, complete or incomplete healing |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 60 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/09/2003 |
| Date of final enrolment | 01/12/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Guy's and St Thomas' NHS Foundation Trust
London
SE1 7EH
United Kingdom
SE1 7EH
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
02/02/2017: No publications found, verifying study status with principal investigator.
