NCT03666754

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

The Effectiveness of Compression and Early Glue Ablation of Saphenous Vein Reflux Compared With Compression Alone in the Healing of Venous Ulcer, a Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Venous Leg Ulcer

Interventions

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

Timeline

• Start date: 2018-09-26
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2018-09-12
• Last updated: 2021-12-17

Locations

1 site across 1 country: Thailand