Does venous surgery improve healing and minimise recurrence of venous ulcers?

ISRCTN	ISRCTN97621126
DOI	https://doi.org/10.1186/ISRCTN97621126
Protocol serial number	G0000328
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (MRC) (UK)

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

Mr Alun Davies
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	USABLE
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	1. Proportion of ulcers completely healed 2. Proportion of ulcers recurring 3. Ulcer healing rate 4. Quality of life 5. Costs
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	28/02/2006
Reason abandoned (if study stopped)	Feasibility grounds

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	1000
Key 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])
Key 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
Date of first enrolment	01/06/2001
Date of final enrolment	28/02/2006

Department of Vascular Surgery

London
W6 8RF
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan