RCT Comparing Standard Cannula Delivered FS, UGFS and ClariVein® in the Management of SVI

• Status: Withdrawn
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hull University Teaching Hospitals NHS Trust; University of Hull
• Treatments: Sodium Tetradecyl Sulfate

Criteria

Inclusion Criteria:

• • Aged 18 or over

• Symptomatic superficial venous insufficiency; Clinical grades C2 - C6; which will likely benefit from treatment in the opinion of an experienced specialist and the participant

• Superficial axial incompetence with proposed treatment lengths of >10cm. This axis may be a great saphenous vein (GSV), anterior accessory saphenous vein (ASV), small saphenous vein (SSV) or Giacomini vein (GV). Multiple veins can be treated.

• The proposed treatment length is straight enough to be cannulated with the catheter devices and the SVI is suitable for treatment with any modality in the study in the view of an experienced specialist

• Willing to participate (including acceptance of randomisation to either treatment) and give valid, informed consent

Exclusion Criteria:

• • Inability to give informed written consent

• Unsuitable for any of the treatments in the opinion of a suitably experienced specialist.

• Unwilling or inability to comply with the requirements for follow-up visits.

• Known allergy to any of the key medications used in the treatment protocols

• Known right to left circulatory shunt

• Evidence of deep venous thrombosis or occlusion

• Active or recent thrombophlebitis (within 6 weeks)

• Impalpable foot pulses and an Ankle-Brachial Pressure Index of less than 0.8

• Pregnancy

• Active malignancy

• Immobility