Early Venous Reflux Ablation (EVRA) ulcer trial

Not Applicable

Completed

• Conditions: Venous disease/leg ulcers; Circulatory System; Ulcer of lower limb, not elsewhere classified

• Registration Number: ISRCTN02335796
• Lead Sponsor: Imperial College London (UK)

Brief Summary

1. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29688123 (added 26/04/2018) 2. 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30741425 (added 12/02/2019) 3. 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31140402 (added 30/05/2019) 4. 2020 results in: https://pubmed.ncbi.nlm.nih.gov/32965493/ (added 24/09/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-03
• Study Completion: 2019-06-30
• Last Update Posted: 5 October 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

1. Current leg ulceration of greater than 6 weeks, but less than 6 months duration
2. Able to give informed consent to participate in the study after reading the patient information documentation
3. Patient age > 18 years
4. Ankle Brachial Pressure Index (ABPI) greater than or equal to 0.8
5. 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)

Patients who cannot speak/understand English will be eligible for inclusion and informed consent will be obtained with assistance from translation services as per standard clinical practice. In view of the lack of cross cultural validation for quality of life tools, only healing outcome data will be collected.

Exclusion Criteria

1. Presence of deep venous occlusive disease or other conditions precluding superficial venous intervention
2. Patients who are unable to tolerate any multilayer compression bandaging will be excluded. However, concordance with compression therapy can be variable for patients at different times. Patients who are generally compliant with compression but unable to tolerate the bandages for short periods will still be eligible for inclusion. A period of noncompliance with compression bandages will not be considered a protocol violation, but a normal variation within the spectrum of standard therapy.
3. Inability of the patient to receive prompt endovenous intervention by the recruiting centre
4. Pregnancy (female participants of reproductive age will be eligible for inclusion in the study, subject to a negative pregnancy test prior to randomisation)
5. Leg ulcer of nonvenous aetiology (as assessed by the responsible clinician)
6. If patient is deemed to require skin grafting they cannot be included

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to ulcer healing (from date of randomization to date of healing)