Condition category
Circulatory System
Date applied
28/02/2007
Date assigned
13/04/2007
Last edited
13/06/2007
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

Mr Keith Poskitt

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

00PRT/6

Study information

Scientific title

Acronym

ESCHAR

Study hypothesis

The surgical correction of superficial venous surgery in addition to compression reduces venous ulcer recurrence in comparison to compression therapy alone.

Ethics approval

Approval received from Gloucestershire Local Research Ethics Committee on the 29th January 1998 (ref: 98/44E).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Chronic venous ulceration

Intervention

Two groups were randomised to either compression therapy alone or compression plus superficial venous surgery.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Ulcer healing
2. Ulcer recurrence

Secondary outcome measures

Ulcer free time

Overall trial start date

01/01/1999

Overall trial end date

01/08/2002

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

500

Participant 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

Recruitment start date

01/01/1999

Recruitment end date

01/08/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Vascular Surgery
Cheltenham
GL53 7AN
United Kingdom

Sponsor information

Organisation

South West NHS R&D Directorate (UK)

Sponsor details

Whiteladies Road
Bristol
BS8 2PR
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Research council

Funder name

Medical Research Council (UK) - interim grant

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

South West NHS R&D Directorate (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

1. Results (2004) in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=15183623
2. Long term results (2007) in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=17545185

Publication citations

  1. Barwell JR, Davies CE, Deacon J, Harvey K, Minor J, Sassano A, Taylor M, Usher J, Wakely C, Earnshaw JJ, Heather BP, Mitchell DC, Whyman MR, Poskitt KR, Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): randomised controlled trial., Lancet, 2004, 363, 9424, 1854-1859, doi: 10.1016/S0140-6736(04)16353-8.

  2. Gohel MS, Barwell JR, Taylor M, Chant T, Foy C, Earnshaw JJ, Heather BP, Mitchell DC, Whyman MR, Poskitt KR, Long term results of compression therapy alone versus compression plus surgery in chronic venous ulceration (ESCHAR): randomised controlled trial., BMJ, 2007, 335, 7610, 83, doi: 10.1136/bmj.39216.542442.BE.

Additional files

Editorial Notes