RCT Comparing Standard Cannula Delivered FS, UGFS and ClariVein® in the Management of SVI
Status:
Withdrawn
Trial end date:
2015-04-01
Target enrollment:
Participant gender:
Summary
Leaking valves in the veins of the legs causes veins to become large and bloated. These
swollen veins are called "varicose veins" and are a very common problem, affecting more than
a third of all adults in the UK. Varicose veins reduce people's quality of life by causing
problems such as pain, itching and restless legs. Varicose veins may also damage the skin
over time causing problems such as bleeding, skin colour changes, eczema and even break-down
in the skin which is called an ulcer. Newer, "key-hole" methods of treating leaky veins have
been developed as an alternative to surgery and can be performed under local anaesthetic with
the patient awake. Rather than cuts in the skin, these minimally invasive techniques are
performed through tiny stab wounds; little larger than needle holes. The varicose vein is
then destroyed from within, usually using heat to burn the inside of the vein. These
procedures are popular; with a rapid recovery and a very high success rate. However these
methods also require the vein to be surrounded by a large volume of dilute local anaesthetic
which can to be slightly painful to administer. A technique called "Foam sclerotherapy"
involves the injection of a drug which has been mixed into a foam. This goes into the vein
and causes it to stick shut. This procedure is near painless to perform as very few, small
local anaesthetic injections are required; however the chance for a successful treatment
first time are lower and patients may need to return for repeat treatments to successfully
treat the vein.
The aim of this study is to see whether the success rates for this technique can be improved.
One method "catheter directed foam sclerotherapy" involves the delivery of the foam through a
catheter (a long very thin tube), so that large lengths of vein can be treated through a
single hole. The final method "ClariVein" again uses a catheter; but this time the catheter
has a small wire on the end which spins around inside the vein; similar to an edge strimmer
in the garden; except it irritates the vein: rather than cutting it. This irritation makes
the vein more susceptible to the drug which can again be applied directly to the vein wall
whilst it is still active. Early results show that this final method is very successful;
however the equipment is more expensive than for the other two.
This study will randomly allocate willing participants with varicose veins to receive one of
these three treatments to see whether the two newer treatments can improve the success rates
and quality of life improvements seen with foam sclerotherapy, whilst also allowing near
painless treatment, without significant complications, at an appropriate cost.
Phase:
Phase 4
Details
Lead Sponsor:
Hull University Teaching Hospitals NHS Trust University of Hull