N/A
N=450
Early Venous Reflux Ablation Ulcer Trial
Venous Leg Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT03286140 ↗Enrolled (actual)
450
Serious AEs
20.2%
Results posted
May 2024
Primary outcome: Primary: Time to Ulcer Healing From Date of Randomisation to Date of Healing up to 365 Days — 82; 56 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Early endovenous ablation (Procedure); Delayed endovenous intervention (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Ulcer Healing From Date of Randomisation to Date of Healing up to 365 Days |
82; 56 | — |
| SECONDARY Percentage of Participants With Ulcer Healing |
76.3; 85.6 | — |
| SECONDARY Ulcer Recurrence / Ulcer Free Time |
32; 24 | — |
| SECONDARY Quality Of Life Questionnaire up to 365 Days |
41.2; 39.4; 39.5; 34.6; 34.3; 32.4 | — |
| SECONDARY Generic (SF-36) Quality of Life Assessment |
45.6; 45.7; 44.5; 44.9; 45.1; 45.3 | — |
| SECONDARY EuroQol-5 Dimensions (EQ-5D) |
71.1; 72.7; 71.4; 74.1; 73.7; 74.8 | — |
| SECONDARY Health Economic Assessment |
2516; 2514 | — |
| SECONDARY Clinical Success - Presence of Residual / Recurrent Reflux in the Veins |
1; 1; 225; 224 | — |
| SECONDARY Clinical Success - VCSS |
12.6; 10.5 | — |
| SECONDARY Clinical Success - Complications |
24; 28 | — |
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
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- Presence of deep venous occlusive disease or other conditions precluding superficial venous intervention (at the discretion of local research team)
- Patients who are unable to tolerate any multilayer compression bandaging / stockings 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 to inclusion. A period of non-compliance with compression bandages will not be considered a protocol violation, but a normal variation within the spectrum of 'standard therapy'.
- Inability of the patient to receive prompt endovenous intervention by recruiting centre
- Pregnancy (female participants of reproductive age will be eligible for inclusion in the study, subject to a negative pregnancy test prior to randomisation)
- Leg ulcer of non-venous aetiology (as assessed by responsible clinician)
- Patient deemed to require skin grafting
Data sourced from ClinicalTrials.gov (NCT03286140). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.