Early Venous Reflux Ablation Ulcer Trial

Browse trials for

• Varicose Ulcer 377
• Leg Ulcer 298

Keywords

• endovenous ablation

Study arms

• Active comparator
  Standard therapy arm

  Multilayer elastic compression bandaging/ stockings with deferred treatment of superficial reflux (usually once the ulcer has healed)

  Procedure: Delayed endovenous intervention

• Experimental
  Early arm

  Early endovenous treatment of superficial venous reflux(within 2 weeks) in addition to standard compression therapy

  Procedure: Early endovenous ablation

Interventions

• ProcedureEarly endovenous ablation
• ProcedureDelayed endovenous intervention

Primary outcomes

1. 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

1. 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

2. 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))

3. 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

4. Generic (SF-36) Quality of Life Assessment

   Generic (SF-36) quality of life assessment The Short Form questionnaire-36 items (SF-36) is a generic quality-of-life tool used to determine people's physical and mental health. It has been validated in many patient groups, including those with varicose veins. The physical domain measures physical functioning, physical role limitations, body pain and general health, whereas the mental dimension measures vitality, social functioning, mental health role limitations and general mental health. Two separate scores are produced (separate physical/mental component summary scores), in addition to the eight separate domain scores. Each score is measured on a scale of 0 to 100 (worst to best). Scores represent the percentage of total possible score achieved.

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

5. EuroQol-5 Dimensions (EQ-5D)

   The EuroQol-5 Dimensions (EQ-5D) is a widely recognised, generic tool to measure health outcomes and has been validated in a variety of patient groups, including those with venous leg ulcers. The EQ-5D questionnaire comprises two sections; the first assesses the participant's mobility, self-care, ability to perform usual activities, pain/discomfort and anxiety/depression levels, and the second records the participant's self-rated health on a vertical score of 0 to 100.

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

6. 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

   Time frame: Baseline, 6 weeks, 6 months, 12 months

7. Clinical Success - Presence of Residual / Recurrent Reflux in the Veins

   The presence of residual / recurrent varicose veins remaining on the venous duplex. Any reflux detected by the vascular scientists (as per local scanning policies) is recorded as presence of residual reflux and therefore considered incomplete clinical success. No presence of residual reflux is considered clinical success. (Clinical-Etiology-Anatomy-Pathophysiology) ranges from C0 which means absolutely no venous disease that can be seen or felt in the legs to C6 which means an open and active venous leg ulcer. For this outcome measure: Healed venous leg ulcer (C5), Active venous leg ulcer (C6).

   Time frame: at 6 weeks

8. Clinical Success - VCSS

   The Venous Clinical Severity Score (VCSS) is a component of the Venous Severity Scoring System designed in 2000 by an ad hoc American Venous Forum committee consensus, in order to compliment the CEAP classification and quantify the severity of disease and subsequent improvement or decline. The VCSS has 10 components (pain, varicose veins, venous oedema, skin pigmentation, inflammation, induration, compression used and active ulcer, duration, number and size), each with four categories assigned values of 0-3. The overall scores can range from 0 (lowest severity) to 30 (highest severity).

   Time frame: at 6 weeks

9. Clinical Success - Complications

   Number of complications related to the endovenous intervention

   Time frame: up to 12 months

Baseline characteristics

Publications

• Gohel MS, Mora MSc J, Szigeti M, Epstein DM, Heatley F, Bradbury A, Bulbulia R, Cullum N, Nyamekye I, Poskitt KR, Renton S, Warwick J, Davies AH; Early Venous Reflux Ablation Trial Group. Long-term Clinical and Cost-effectiveness of Early Endovenous Ablation in Venous Ulceration: A Randomized Clinical Trial. JAMA Surg. 2020 Dec 1;155(12):1113-1121. doi: 10.1001/jamasurg.2020.3845. PubMed 32965493 ↗
• Gohel MS, Heatley F, Liu X, Bradbury A, Bulbulia R, Cullum N, Epstein DM, Nyamekye I, Poskitt KR, Renton S, Warwick J, Davies AH. Early versus deferred endovenous ablation of superficial venous reflux in patients with venous ulceration: the EVRA RCT. Health Technol Assess. 2019 May;23(24):1-96. doi: 10.3310/hta23240. PubMed 31140402 ↗

Related links

• Trial website ↗

Study documents

• Study protocol · Apr 6, 2017
• Statistical analysis plan · Oct 26, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — 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: 1. A commitment to using the data only for research purposes and not to identify any individual participant; 2. A commitment to securing the data using appropriate computer technology; 3. 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.