Early Venous Reflux Ablation Ulcer Trial

NCT03286140 | Completed Results DMC

• 1 other identifier: 13HH0722
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

The EVRA study evaluates the effects of early endovenous ablation on ulcer healing in patients with chronic venous ulceration. Half the patients are randomised to receive early endovenous ablation (within 2 weeks) and half to standard care

Conditions

Venous Leg Ulcer

Keywords

endovenous ablation

Outcome Measures

Primary Outcomes (1)

• Time to Ulcer Healing From Date of Randomisation to Date of Healing up to 365 Days

  For the purposes of this study, ulcer healing is defined as complete re-epithelialisation of all ulceration on the randomised (reference) leg in the absence of a scab (eschar) with no dressing required.

  time from date of randomisation to date of healing up to 365 days

Secondary Outcomes (9)

• Percentage of Participants With Ulcer Healing

  24 weeks & time to ulcer healing up to 365 days

• Ulcer Recurrence / Ulcer Free Time

  Up to 12 months (and with the extension, up to 5 years (median approximately 3.7 years))

• Quality Of Life Questionnaire up to 365 Days

  6 weeks post randomisation, 6 months, 12 months

• Generic (SF-36) Quality of Life Assessment

  6 weeks post randomisation, 6 months, 12 months

• EuroQol-5 Dimensions (EQ-5D)

  6 weeks post randomisation, 6 months, 12 months

Study Arms (2)

Standard therapy arm

ACTIVE COMPARATOR

Multilayer elastic compression bandaging/ stockings with deferred treatment of superficial reflux (usually once the ulcer has healed)

Procedure: Delayed endovenous intervention

Early arm

EXPERIMENTAL

Early endovenous treatment of superficial venous reflux(within 2 weeks) in addition to standard compression therapy

Procedure: Early endovenous ablation

Interventions

Early endovenous ablation PROCEDURE

Early arm

Delayed endovenous intervention PROCEDURE

Standard therapy arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current leg ulceration of greater than 6 weeks, but less than 6 months duration
• Able to give informed consent to participate in the study after reading the patient information documentation
• Patient age \> 18 years
• Ankle Brachial Pressure Index (ABPI) ≥ 0.8
• Superficial venous disease on colour duplex assessment deemed to be significant enough to warrant ablation by the treating clinician (either primary or recurrent venous reflux)

You may not qualify if:

• Presence of deep venous occlusive disease or other conditions precluding superficial venous intervention (at the discretion of local research team)
• Inability of the patient to receive prompt endovenous intervention by recruiting centre
• Leg ulcer of non-venous aetiology (as assessed by responsible clinician)
• Patient deemed to require skin grafting

Sponsors & Collaborators

• Imperial College London: lead
• University of Birmingham: collaborator
• Universidad de Granada: collaborator
• University of Manchester: collaborator
• University of Warwick: collaborator

Study Sites (1)

Imperial College London

London, W68RF, United Kingdom

Location

Related Publications (2)

• Gohel MS, Mora MSc J, Szigeti M, Epstein DM, Heatley F, Bradbury A, Bulbulia R, Cullum N, Nyamekye I, Poskitt KR, Renton S, Warwick J, Davies AH; Early Venous Reflux Ablation Trial Group. Long-term Clinical and Cost-effectiveness of Early Endovenous Ablation in Venous Ulceration: A Randomized Clinical Trial. JAMA Surg. 2020 Dec 1;155(12):1113-1121. doi: 10.1001/jamasurg.2020.3845.

  PMID: 32965493 RESULT

• Gohel MS, Heatley F, Liu X, Bradbury A, Bulbulia R, Cullum N, Epstein DM, Nyamekye I, Poskitt KR, Renton S, Warwick J, Davies AH. Early versus deferred endovenous ablation of superficial venous reflux in patients with venous ulceration: the EVRA RCT. Health Technol Assess. 2019 May;23(24):1-96. doi: 10.3310/hta23240.

  PMID: 31140402 RESULT

Related Links

• Trial website

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Professor Alun Davies
• Organization: Imperial College London

a.h.davies@imperial.ac.uk

+44 (0)20 3311 7309

Study Officials

• Gerard Stansby

  Newcastle University

  STUDY CHAIR

• Julie Brittenden

  University of Glasgow

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded assessment of ulcer healing photos
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The EVRA ulcer trial is a pragmatic; multicentre randomised clinical trial with participants randomised1:1 to either: 1. 'Standard' therapy consisting of multilayer elastic compression bandaging/ stockings with deferred treatment of superficial reflux (usually once the ulcer has healed) 2. Early endovenous treatment of superficial venous reflux(within 2 weeks) in addition to standard therapy

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: September 18, 2017
• Study Start: September 1, 2013
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: May 20, 2024
• Results First Posted: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)