Condition category
Circulatory System
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
14/03/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Kevin Burnand

ORCID ID

Contact details

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
+44 (0)20 7188 2570
Kevin.burnand@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0013146069

Study information

Scientific title

Acronym

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

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 2 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 Specified

Drug names

Haemosiderin

Primary outcome measures

Ulcer sizes, complete or incomplete healing.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2003

Overall trial end date

01/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

60 patients will be recruited from the venous ulcer out patients clinic at St Thomas' Hospital.

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

United Kingdom

Trial participating centre

Guy's and St Thomas' NHS Foundation Trust
London
SE1 7EH
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Guy's and St. Thomas' NHS Foundation Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Own Account - NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes