A study to investigate the Effect of Surgery and Compression on Healing And Recurrence in chronic venous ulceration

ISRCTN	ISRCTN07549334
DOI	https://doi.org/10.1186/ISRCTN07549334
Protocol serial number	00PRT/6
Sponsor	South West NHS R&D Directorate (UK)
Funders	Medical Research Council (UK) - interim grant, South West NHS R&D Directorate (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Keith Poskitt
Scientific

Department of Vascular Surgery
Cheltenham General Hospital
Sandford Road
Cheltenham
GL53 7AN
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	ESCHAR
Study objectives	The surgical correction of superficial venous surgery in addition to compression reduces venous ulcer recurrence in comparison to compression therapy alone.
Ethics approval(s)	Approval received from Gloucestershire Local Research Ethics Committee on the 29th January 1998 (ref: 98/44E).
Health condition(s) or problem(s) studied	Chronic venous ulceration
Intervention	Two groups were randomised to either compression therapy alone or compression plus superficial venous surgery.
Intervention type	Other
Primary outcome measure(s)	1. Ulcer healing 2. Ulcer recurrence
Key secondary outcome measure(s)	Ulcer free time
Completion date	01/08/2002

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	500
Key inclusion criteria	Open or recently healed leg ulceration (within six months) of greater than four weeks duration between knee and malleoli, with Ankle Brachial Pressure Index (ABPI) above 0.85 and duplex evidence of superficial with or without deep venous reflux.
Key exclusion criteria	1. Duplex imaging not possible 2. Patient unable/unwilling to give informed consent 3. Deep venous occlusion 4. Unfit for surgery (even under local anaesthetic) 5. Multilayer compression therapy not practical 6. Malignant ulceration
Date of first enrolment	01/01/1999
Date of final enrolment	01/08/2002

Department of Vascular Surgery

Cheltenham
GL53 7AN
United Kingdom

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results ()	05/06/2004		Yes	No
Results article	Long term results ()	14/07/2007		Yes	No