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

Not Applicable

• Conditions: Venous Leg Ulcer
• Interventions: Procedure: Standard therapy arm; Procedure: Early endovenous glue embolization arm

• Registration Number: NCT03666754
• Lead Sponsor: Mahidol University

Brief Summary

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

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-09-10
• Study First Submitted QC: 2018-09-10
• Study First Posted: 2018-09-12
• Study Start: 2018-09-26
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-16
• Last Update Posted: 2021-12-17
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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)

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard therapy arm	Standard therapy arm	Multilayer elastic compression bandaging/ stockings with the deferred treatment of superficial reflux (usually once the ulcer has healed)
Early endovenous glue embolization arm	Early endovenous glue embolization arm	Early endovenous glue embolization of superficial venous reflux within 2 weeks in addition to standard compression therapy

Primary Outcome Measures

Name	Time	Method
Time to ulcer healing	time from date of randomisation to date of healing within the 12 month study period	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.

Secondary Outcome Measures

Name	Time	Method
Quality Of Life SF36	6 weeks post randomisation, 6 months, 12 months	Generic (SF36) quality of life assessment
Quality Of Life CIVIQ-20	6 weeks post randomisation, 6 months, 12 months	CIVIQ-20 assessment
Quality Of Life EQ5D	6 weeks post randomisation, 6 months, 12 months	Generic (EQ5D )quality of life assessment
Ulcer Healing Rate	24 weeks & time to ulcer healing within the 12 month study period	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	Up to 12 months	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.
Clinical Success - Presence of residual / recurrent varicose veins	at 6 weeks	The presence of residual / recurrent varicose veins remaining on the venous duplex
Clinical Success - VCSS	at 6 weeks	The Venous Clinical Severity Score (VCSS)
Clinical Success - Complications	up to 12 months	Incidence of complications related to the endovenous intervention

Trial Locations

Locations (1)

Vascular Surgery, Siriraj Hospital, Mahidol University; 🇹🇭 Bangkoknoi, Bangkok, Thailand