Axial Ablation Versus Terminal Interruption of the Reflux Source

Not Applicable

• Conditions: Venous Ulcer
• Interventions: Procedure: Terminal Interruption of the Reflux Source; Procedure: Axial Ablation

• 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

Study Timeline

• Study First Submitted: 2020-07-20
• Study First Submitted QC: 2020-07-20
• Study Start: 2020-07-21
• Study First Posted: 2020-07-23
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-18
• Primary Completion: 2022-10
• Study Completion: 2022-10

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

Arm && Interventions

Group	Intervention	Description
Terminal Interruption of the Reflux Source (TIRS	Terminal Interruption of the Reflux Source	These patients will have foam sclerotherapy of the veins in the immediate vicinity of their venous ulcer and thereafter be managed in compression bandaging and followed up fro 6 months or until the ulcer has healed
Axial Ablation	Axial Ablation	These patients will undergo endovenous ablation of the great or small saphenous veins, or other large superficial veins exhibiting significant reflux

Primary Outcome Measures

Name	Time	Method
Ulcer healing	6 months	The main outcome measure is the proportion of ulcers which have healed within the follow up period

Secondary Outcome Measures

Name	Time	Method
Ulcer Healing	3 months	The proportion of ulcers healed at three months
Wound Progress	6 months	Progress in Wound regeneration as indicated by changes in Bates-Jensen Wound Assessment Tool (BWAT)
Change in Venous disease related quality of Live	6 months	Changes in Charing Cross Venous Ulcer Quesionnaire score from randomisation to exit from the study
Reduction in ulcer size	6 months	The absolute reduction in ulcer size in square cm
Relative Reduction in ulcer size	6 months	Reduction in ulcer size as a percentage of original ulcer area
Change in overall venous disease	6 months	Monthly change in Venous Clinical Severity Score

Trial Locations

Locations (1)

Roscommon Unversity Hospiral; 🇮🇪 Roscommon, Ireland