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 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
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