Early Venous Reflux Ablation Ulcer Trial

Imperial College London450 enrolled

Overview

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

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. However, when there is an underlying problem with the skin, ulcers do not heal and may result in longstanding (chronic), painful, smelly and embarrassing wounds. The ulcers are often due to varicose veins in the legs, which can cause skin breakdown and ulcer formation. To get the ulcer to heal, the current best treatment is to wear a tight compression bandage with multiple layers, with which about 60% of these ulcers will heal within 24 weeks. There is evidence that treatment of the varicose veins by surgery will prevent the ulcer from returning after it has healed. Recent studies have suggested that newer techniques of treating varicose veins, such as injecting a medicine into the varicose vein (sclerotherapy) or treating the vein with heat ablation to seal it (using laser or radiofrequency), in an outpatient setting may help the ulcers to heal more quickly and (like surgery) reduce the chance of the ulcer coming back. These techniques can be carried out in the outpatient setting and are much better tolerated by patients in comparison to surgery. The aim of this study is to see whether early treatment of varicose veins using sclerotherapy or heat ablation helps with healing.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

450

Conditions

Venous Leg Ulcer

Interventions

Early endovenous ablationPROCEDURE

Delayed endovenous interventionPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Imperial College London

London, United Kingdom

Outcomes

Primary Outcomes

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

Secondary Outcomes

Percentage of Participants With Ulcer Healing

Healing rate will be reported at 24 weeks using the percentage of participants with a healed ulcer

Time frame: 24 weeks & time to ulcer healing up to 365 days

Ulcer Recurrence / Ulcer Free Time

Will be calculated up to 1 year for each study arm and with the extension, up to 5 years (median approximately 3.7 years). This will allow a very practical and easily understood assessment of the clinical difference between the 2 arms of the study. This will also allow comparison with other studies that have reported this outcome. In order to facilitate accurate calculation of reoccurrence / ulcer free time, clinical follow up will be continued after ulcer healing up to 1 year after randomisation.

Time frame: 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

Disease specific (AVVQ) quality of life The Aberdeen Varicose Vein Questionnaire (AVVQ) is a validated patient-reported disease-specific health questionnaire to assess quality of life in patients with varicose veins. The AVVQ comprises a diagram on which patients draw on their varicose veins and a questionnaire with 12 questions, half of which require a response for each leg. The scores range from 0 to 100 (no effect to severe effect).

Time frame: 6 weeks post randomisation, 6 months, 12 months

Generic (SF-36) Quality of Life Assessment

Data from ClinicalTrials.gov

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