MedPath

Axial Ablation Versus Terminal Interruption of the Reflux Source

Not Applicable
Conditions
Venous Ulcer
Registration Number
NCT04484168
Lead Sponsor
University College Hospital Galway
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
308
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Ulcer healing6 months

The main outcome measure is the proportion of ulcers which have healed within the follow up period

Secondary Outcome Measures
NameTimeMethod
Ulcer Healing3 months

The proportion of ulcers healed at three months

Wound Progress6 months

Progress in Wound regeneration as indicated by changes in Bates-Jensen Wound Assessment Tool (BWAT)

Change in Venous disease related quality of Live6 months

Changes in Charing Cross Venous Ulcer Quesionnaire score from randomisation to exit from the study

Reduction in ulcer size6 months

The absolute reduction in ulcer size in square cm

Relative Reduction in ulcer size6 months

Reduction in ulcer size as a percentage of original ulcer area

Change in overall venous disease6 months

Monthly change in Venous Clinical Severity Score

Trial Locations

Locations (1)

Roscommon Unversity Hospiral

🇮🇪

Roscommon, Ireland

Roscommon Unversity Hospiral
🇮🇪Roscommon, Ireland
Colum R Keohane, MB BCh BAO
Contact
00353876492372
columkeohane@rcsi.ie

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.