Axial Ablation Versus Terminal Interruption of the Reflux Source
- 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
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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
Roscommon Unversity Hospiral🇮🇪Roscommon, IrelandColum R Keohane, MB BCh BAOContact00353876492372columkeohane@rcsi.ie