Condition category
Circulatory System
Date applied
18/10/2000
Date assigned
18/10/2000
Last edited
29/07/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Alun Davies

ORCID ID

Contact details

Department of Vascular Surgery
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G0000328

Study information

Scientific title

Acronym

USABLE

Study hypothesis

To investigate whether simple venous surgery improves the clinical and cost-effectiveness of four layer bandaging for venous ulcers in terms both healing and recurrence.

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

Treatment

Patient information sheet

Condition

Venous ulcers

Intervention

1. Compression bandaging plus venous surgery
2. Compression bandaging alone

Trial closed early on 15/01/03 on feasibility grounds.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Proportion of ulcers completely healed
2. Proportion of ulcers recurring
3. Ulcer healing rate
4. Quality of life
5. Costs

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2001

Overall trial end date

28/02/2006

Reason abandoned

Feasibility grounds

Eligibility

Participant inclusion criteria

Venous ulcers associated with venous abnormality (superficial vein incompetence, with or without incompetent perforators, with or without deep vein incompetence, suitable for simple surgical correction, with or without perforating vein surgery [as shown by colour duplex scanning])

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1000

Participant exclusion criteria

1. Ankle Brachial Pressure Index (ABPI) less than 0.8
2. Intolerant to compression bandaging
3. Less than six months to live
4. Deep vein occlusion surgery and compression versus compression only

Recruitment start date

01/06/2001

Recruitment end date

28/02/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Vascular Surgery
London
W6 8RF
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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