A randomized clinical trial to compare early versus delayed treatment of superficial venous reflux in patients with chronic venous ulceration. Early Venous Reflux Ablation (EVRA) ulcer trial
A UK-wide clinical trial is testing whether treating damaged leg veins within two weeks of diagnosis—rather than waiting for ulcers to heal first—can speed up recovery in patients with chronic leg ulcers. These open sores, lasting more than six weeks, affect tens of thousands of people and are notoriously slow to heal. Standard care involves compression bandaging alone, but many ulcers recur or never fully close. The underlying cause is often superficial venous reflux—leaky valves in leg veins that allow blood to pool. This trial asks whether adding early endovenous treatment (using foam, laser, or radiofrequency to seal the faulty veins) to compression therapy can heal ulcers faster and keep them healed longer. If early ablation proves more effective, it could transform NHS leg ulcer care—shifting from a watch-and-wait approach to an active, early intervention. Faster healing would reduce patient suffering, lower district nurse visits, and cut long-term costs for the health service. The trial also includes a full economic analysis to determine whether the upfront cost of early treatment is offset by savings from fewer recurrences and less ongoing care.
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STUDY DESIGN: Multicentre randomized clinical trial RESEARCH QUESTION: What is the clinical and cost effectiveness of early endovenous treatment of superficial venous reflux in addition to standard care compared to standard care alone in patients with chronic venous ulceration? HEALTH TECHNOLOGIES BEING ASSESSED: 1) Multilayer elastic compression bandaging (control group); 2) Multilayer elastic compression bandaging plus early treatment of superficial venous reflux using endovenous interventions (ultrasound guided foam sclerotherapy, endovenous laser or radiofrequency ablation). The choice of endovenous modality will be left to the discretion of the responsible clinician, in the patient’s best interests. However, the only stipulation will be that the first stage of the endovenous treatment strategy should be planned within 2 weeks of randomisation, if possible. SETTING: Hospital and community run leg ulcer clinics within Vascular Surgery Departments from across the UK. A total of 20 NHS Trusts have randomised participants in the trial. 1. Imperial College Healthcare NHS Trust 2. Cambridge University Hospitals NHS Foundation Trust 3. Worcestershire Acute Hospitals NHS Trust 4. North West London Hospitals NHS Trust 5. Gloucestershire Hospitals NHS Foundation Trust 6. Heart of England NHS Trust 7. University Hospital Birmingham NHS Trust 8. City and Sandwell NHS Trust 9. The Dudley Group NHS Trust 10. The Royal Wolverhampton Hospitals NHS Trust 11. York Hospitals NHS Foundation Trust 12. Hull & East Yorkshire Hospitals NHS Trust 13.The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust 14. Frimley Park Hospital NHS Foundation Trust 15. Plymouth Hospitals NHS Trust 16. Bradford Teaching Hospitals NHS Foundation Trust 17. Salisbury NHS Foundation Trust 18. Leeds Teaching Hospitals NHS Trust 19. Sheffield Teaching Hospitals NHS Foundation Trust 20. Taunton and Somerset NHS Foundation Trust TARGET POPULATION: Patients with open chronic leg ulceration (>6 weeks duration) will be targeted in hospital and community settings. In patients with bilateral venous ulceration, the worst leg (as assessed by the patient) will be designated the ‘reference’ leg. Adults over 18 years of age with superficial venous reflux (in great, small or non-saphenous veins) of >1s duration, will be assessed for eligibility. Exclusion criteria will include current deep vein thrombosis (DVT) or obstruction, arterial disease (ABPI<0.8), pregnancy, non-compliance with multilayer elastic compression and inability to perform prompt endovenous intervention. OUTCOME MEASURES: The primary outcome measure will be time to ulcer healing. Secondary outcomes will be ulcer healing rate, ulcer free time (to 1 year), Quality of life (generic and disease specific), health economic assessments (using in trial analysis and modelling techniques) and other markers of clinical success (including VCSS and incidence of complications). The economic evaluation will be based on both a modeling exercise and a patient level in-trial analysis, developed from the model used for another HTA funded project (REACTIV trial). SAMPLE SIZE: Participants will be randomized to two groups: multilayer elastic compression bandaging alone (standard therapy) or multilayer elastic compression plus early endovenous treatment of superficial reflux. In order to calculate a sample size for this study, a benefit associated with early treatment is estimated at around 15%. Assuming the 24-week healing rate in the standard arm is 60%, to identify a difference in 24-week healing rates of 15% between the two groups (60% vs 75%) with 90% power and allowing for 10% dropout the study will therefore require 416 subjects (208 in each arm, 254 healed leg ulcers in total). To incorporate further allowances for protocol violations and unexpected dropouts, the target sample size will be 450 patients. RANDOMISATION: Consenting participants will be registered
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