Back to resultsEarly Venous Reflux Ablation Ulcer Trial (EVRA)
Primary Purpose
Venous Leg Ulcer
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Early endovenous ablation
Delayed endovenous intervention
Sponsored by
About this trial
This is an interventional treatment trial for Venous Leg Ulcer focused on measuring endovenous ablation
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
Sites / Locations
- Imperial College London
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard therapy arm
Early arm
Arm Description
Multilayer elastic compression bandaging/ stockings with deferred treatment of superficial reflux (usually once the ulcer has healed)
Early endovenous treatment of superficial venous reflux(within 2 weeks) in addition to standard compression therapy
Outcomes
Primary Outcome Measures
Time to ulcer healing
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.
Secondary Outcome Measures
Ulcer Healing Rate
Healing rate will be reported at 24 weeks in addition to time to ulcer healing to allow comparison with other published studies
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.
Quality Of Life Questionnaire
Disease specific (AVVQ) quality of life
Quality Of Life Questionnaire
Generic (SF36) quality of life assessment
Quality Of Life Questionnaire
Generic (EQ5D )quality of life assessment
Health Economic Assessment
A within-RCT cost effectiveness analysis will be carried out based on the data collected in the trial, Resource use items in hospital and community care related to the treatment of venous ulceration or complications will be recorded for each patient at each follow-up. Resource use will be multiplied by UK unit costs obtained from published literature, HRG costs, and manufacturers' list prices to calculate overall costs. A standard tariff will be applied for each bandage change. Utilities (QALYs) will be calculated from the EQ-5D questionnaire administered to patients
Clinical Success - Presence of residual / recurrent varicose veins
The presence of residual / recurrent varicose veins remaining on the venous duplex
Clinical Success - VCSS
The Venous Clinical Severity Score (VCSS)
Clinical Success - Complications
Incidence of complications related to the endovenous intervention
Full Information
NCT ID
NCT03286140
First Posted
September 4, 2017
Last Updated
July 10, 2019
Sponsor
Imperial College London
Collaborators
University of Birmingham, Universidad de Granada, University of Manchester, University of Warwick
1. Study Identification
Unique Protocol Identification Number
NCT03286140
Brief Title
Early Venous Reflux Ablation Ulcer Trial
Acronym
EVRA
Official Title
A Randomised Clinical Trial to Compare Early Versus Delayed Endovenous Treatment of Superficial Venous Reflux in Patients With Chronic Venous Ulceration
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2013 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
March 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
University of Birmingham, Universidad de Granada, University of Manchester, University of Warwick
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 (within 2 weeks) and half to standard care
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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcer
Keywords
endovenous ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The EVRA ulcer trial is a pragmatic; multicentre randomised clinical trial with participants randomised1:1 to either:
'Standard' therapy consisting of multilayer elastic compression bandaging/ stockings with deferred treatment of superficial reflux (usually once the ulcer has healed)
Early endovenous treatment of superficial venous reflux(within 2 weeks) in addition to standard therapy
Masking
Outcomes Assessor
Masking Description
Blinded assessment of ulcer healing photos
Allocation
Randomized
Enrollment
450 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard therapy arm
Arm Type
Active Comparator
Arm Description
Multilayer elastic compression bandaging/ stockings with deferred treatment of superficial reflux (usually once the ulcer has healed)
Arm Title
Early arm
Arm Type
Experimental
Arm Description
Early endovenous treatment of superficial venous reflux(within 2 weeks) in addition to standard compression therapy
Intervention Type
Procedure
Intervention Name(s)
Early endovenous ablation
Intervention Type
Procedure
Intervention Name(s)
Delayed endovenous intervention
Primary Outcome Measure Information:
Title
Time to ulcer healing
Description
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 within the 12 month study period
Secondary Outcome Measure Information:
Title
Ulcer Healing Rate
Description
Healing rate will be reported at 24 weeks in addition to time to ulcer healing to allow comparison with other published studies
Time Frame
24 weeks & time to ulcer healing within the 12 month study period
Title
Ulcer recurrence / Ulcer Free Time
Description
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))
Title
Quality Of Life Questionnaire
Description
Disease specific (AVVQ) quality of life
Time Frame
6 weeks post randomisation, 6 months, 12 months and at one time point between October 2018 and March 2019
Title
Quality Of Life Questionnaire
Description
Generic (SF36) quality of life assessment
Time Frame
6 weeks post randomisation, 6 months, 12 months and at one time point between October 2018 and March 2019
Title
Quality Of Life Questionnaire
Description
Generic (EQ5D )quality of life assessment
Time Frame
6 weeks post randomisation, 6 months, 12 months and at one time point between October 2018 and March 2019
Title
Health Economic Assessment
Description
A within-RCT cost effectiveness analysis will be carried out based on the data collected in the trial, Resource use items in hospital and community care related to the treatment of venous ulceration or complications will be recorded for each patient at each follow-up. Resource use will be multiplied by UK unit costs obtained from published literature, HRG costs, and manufacturers' list prices to calculate overall costs. A standard tariff will be applied for each bandage change. Utilities (QALYs) will be calculated from the EQ-5D questionnaire administered to patients
Time Frame
Baseline, 6 weeks, 6 months, 12 months
Title
Clinical Success - Presence of residual / recurrent varicose veins
Description
The presence of residual / recurrent varicose veins remaining on the venous duplex
Time Frame
at 6 weeks
Title
Clinical Success - VCSS
Description
The Venous Clinical Severity Score (VCSS)
Time Frame
at 6 weeks
Title
Clinical Success - Complications
Description
Incidence of complications related to the endovenous intervention
Time Frame
up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerard Stansby
Organizational Affiliation
Newcastle University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Julie Brittenden
Organizational Affiliation
University of Glasgow
Official's Role
Study Chair
Facility Information:
Facility Name
Imperial College London
City
London
ZIP/Postal Code
W68RF
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
At completion of the study, data will be shared in accordance with the NIHR HTA guidance on study outputs as per the research contract between the secretary of state for health research and Imperial College London. Only anonymised data will be shared under the terms of the consent forms.
Data and associated documentation will be available to users only under a data-sharing agreement that provides for the following:
A commitment to using the data only for research purposes and not to identify any individual participant;
A commitment to securing the data using appropriate computer technology;
A commitment to destroying or returning the data after analyses are completed. All requests are dealt with on a case-by-case basis. Any request should be submitted to the corresponding author who will then review with the Trial Management Group and sponsor. A record of all access to data will be maintained by the Imperial College Archive team.
Learn more about this trial
Early Venous Reflux Ablation Ulcer Trial
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