NCT04484168

Axial Ablation Versus Terminal Interruption of the Reflux Source

Axial Ablation Versus Terminal Interruption of the Reflux Source (AAVTIRS): A Randomised Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 308 (estimated)
• Sponsor: University College Hospital Galway · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This randomised trial aims to compare the effect on ulcer healing of different means of managing venous reflux in the lower limb. It is a non-inferiority trial comparing endovenous ablation of the axial (Saphenous and other large veins) veins of the lowere limb, versus terminal interruption of the reflux source (TIRS). For the purposes of this trial TIRS will be achieved using foam sclerotherapy of the distal tributaries in the immediate vicinity of the ulcer being treated.

Conditions

• Venous Ulcer

Interventions

Type	Name	Description
PROCEDURE	Terminal Interruption of the Reflux Source	Foam Sclerotherapy of veins in the immediate vicinity of the venous ulcer
PROCEDURE	Axial Ablation	Endovenous ablation of venous reflux in the main superficial veins of the leg

Timeline

• Start date: 2020-07-21
• Primary completion: 2022-10-01
• Completion: 2022-10-01
• First posted: 2020-07-23
• Last updated: 2022-05-18

Locations

1 site across 1 country: Ireland