MedTrace Logo

Axial Ablation Versus Terminal Interruption of the Reflux Source

NCT04484168 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 308

Last updated 2022-05-18

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Stewart R Walsh

    collaborator UNKNOWN

  • Wael Tawfick

    collaborator UNKNOWN

  • Thomas A Aherne

    collaborator UNKNOWN

  • Mark Twyford

    collaborator UNKNOWN

  • Marie O'Shaughnessy

    collaborator UNKNOWN

  • University College Hospital Galway

    lead OTHER

Principal Investigators

  • Colum R Keohane, MB,BCh,BAO · UCH Galway and NUI Galway

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-21
Primary Completion
2022-10-31
Completion
2022-10-31

Countries

  • Ireland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04484168 on ClinicalTrials.gov