Early Glue Saphenous Vein Ablation With Compression Versus Compression Alone in the Healing of the Venous Ulcer

Mahidol University80 enrolled

Overview

The study evaluates the effects of early endovenous glue ablation on ulcer healing in patients with chronic venous ulceration. Half the patients are randomized to receive early endovenous ablation (within 2 weeks) and a half to standard care

To get the venous leg ulcer to heal, the current best treatment is to wear a multi-component compression bandage, 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 sclerotherapy, laser or radiofrequency in an outpatient setting may help the ulcers to heal more quickly and reduce the chance of the ulcer recurrence. The aim of this study is to see whether early treatment of varicose veins using endovenous glue embolization helps with healing.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Venous Leg Ulcer

Interventions

Standard therapy armPROCEDURE

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

Early endovenous glue embolization armPROCEDURE

Early endovenous glue embolization of superficial venous reflux within 2 weeks in addition to standard compression therapy

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 * Patients who are unable to tolerate any multilayer compression bandaging / stockings will be excluded. * The inability of the patient to receive the prompt endovenous intervention * Pregnancy (female participants of reproductive age will be eligible for inclusion in the study, subject to a negative pregnancy test prior to randomisation)

Locations (1)

Vascular Surgery, Siriraj Hospital, Mahidol University

Bangkoknoi, Bangkok, Thailand

RECRUITING

Outcomes

Primary Outcomes

Time to ulcer healing

For the purposes of this study, ulcer healing is defined as complete re-epithelialization of all ulceration on the randomized (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 Outcomes

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

Time frame: 24 weeks & time to ulcer healing within the 12 month study period

Ulcer recurrence / Ulcer Free Time

Will be calculated up to 1 year for each study arm to 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 randomization.

Time frame: Up to 12 months

Quality Of Life SF36

Generic (SF36) quality of life assessment

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

Quality Of Life CIVIQ-20

CIVIQ-20 assessment

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

Quality Of Life EQ5D

Generic (EQ5D )quality of life assessment

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

Clinical Success - Presence of residual / recurrent varicose veins

Central Contacts

Nuttawut Sermsathanasawadi,, MD

CONTACT

6624198021 nutttawut@gmail.com

Nuttawut Sermsathanasawadi, MD

CONTACT

6624198021 nutttawut@gmail.com

Data from ClinicalTrials.gov

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