Status:
COMPLETED
Early Venous Reflux Ablation Ulcer Trial
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
University of Birmingham
Universidad de Granada
Conditions:
Venous Leg Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
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 (wi...
Detailed Description
A large number of patients (around 1% of the adult population) suffer from an ulcer (break in the skin surface) near the ankle. In most people, such an injury should heal up within a week or two. Howe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2019
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT03286140
Start Date
September 1 2013
End Date
March 31 2019
Last Update
May 20 2024
Active Locations (1)
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1
Imperial College London
London, United Kingdom, W68RF