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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
308
Foam Sclerotherapy of veins in the immediate vicinity of the venous ulcer
Endovenous ablation of venous reflux in the main superficial veins of the leg
Roscommon Unversity Hospiral
Roscommon, Ireland
RECRUITINGUlcer healing
The main outcome measure is the proportion of ulcers which have healed within the follow up period
Time frame: 6 months
Ulcer Healing
The proportion of ulcers healed at three months
Time frame: 3 months
Reduction in ulcer size
The absolute reduction in ulcer size in square cm
Time frame: 6 months
Relative Reduction in ulcer size
Reduction in ulcer size as a percentage of original ulcer area
Time frame: 6 months
Wound Progress
Progress in Wound regeneration as indicated by changes in Bates-Jensen Wound Assessment Tool (BWAT)
Time frame: 6 months
Change in overall venous disease
Monthly change in Venous Clinical Severity Score
Time frame: 6 months
Change in Venous disease related quality of Live
Changes in Charing Cross Venous Ulcer Quesionnaire score from randomisation to exit from the study
Time frame: 6 months
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