Condition category
Circulatory System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
14/07/2008
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

Professor Charles Nevin McCollum

ORCID ID

Contact details

Academic Department of Surgery
South Manchester University Hospitals NHS Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 0161 291 5853 (Barbara)
CNMCC@man.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0226118474

Study information

Scientific title

Acronym

Study hypothesis

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

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 ulcer

Intervention

Surgery to take place within 4 weeks of randomisation.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Improvement in venous function.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/2002

Overall trial end date

30/06/2004

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Added July 2008: 32 subjects

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/07/2002

Recruitment end date

30/06/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Department of Surgery
Manchester
M23 9LT
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

South Manchester University Hospitals NHS Trust (UK)

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

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16096860

Publication citations

  1. Results

    Dix FP, Picton A, McCollum CN, Effect of superficial venous surgery on venous function in chronic venous insufficiency., Ann Vasc Surg, 2005, 19, 5, 678-685, doi: 10.1007/s10016-005-6869-6.

Additional files

Editorial Notes