Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Dual Centre, Randomised Controlled Trial of the Clinical and Cost Effectiveness of Endovenous Laser Therapy (EVLT) in the Treatment of Varicose Veins and Venous Ulcers
Brief Summary: Varicose veins are a common problem, affecting up to a third of the western adult population. Most suffer with aching, discomfort, pruritis, and muscle cramps, whilst complications include oedema, eczema, lipodermatosclerosis, ulceration, phlebitis, and bleeding. This is known to have a significant negative effect on patient's quality of life (QoL).

Surgery has been used for many years, but it is known that there is a temporary decline in QoL post-op. This was demonstrated in our pilot study. Surgery leads to painful and prolonged recovery in some patients and has the risks of infection, haematoma and nerve injury.

Recurrence rates are known to be significant. Duplex of veins post surgery has demonstrated persistent reflux in 9-29% of cases at 1 year, 13-40% at 2 years, 40% at 5 years and 60% at 34 years.

26% of NHS patients were 'very dissatisfied' with their varicose vein surgery.

Newer, less invasive treatments are being developed. It would be advantageous to find a treatment that avoided the morbidity of surgery, one that could be performed as a day-case procedure under a local anaesthetic, a treatment that could offer lower recurrence rates and allow an early return to work. These should be the aims of any new treatment for varicose veins.

Endovenous Laser Treatment (EVLT) is performed under a local anaesthetic and uses laser energy delivered into the vein to obliterate it. The vein therefore need not be tied off surgically and stripped out.

The aim of this study is to compare the clinical, cost effectiveness and safety of Surgery and EVLT.


Options:
A: Inclusion Criteria:

* age between 18 and 80 years old
* venous ulcer appeared at least 4 weeks, bellow knee
* ankle-brachial index more than 0.9
* saphenous veins insufficiency plus perforating veins reflux
* saphenous vein diameter between 5 mm and 12 mm
* absence of saphenous veins thrombophlebitis
* absence of personal history of venous deep thrombosis
* absence of ultrasound evidence of actual or previous venous deep thrombosis
* absence of severe ankle anquilosis

Exclusion Criteria:

* Unable to provide informed consent
* Unable to receive surgical intervention due to severe clinical condition
B: Inclusion Criteria:

* Aged 18 or over
* Symptomatic SVI which will likely benefit from treatment in the opinion of an experienced specialist and the participant
* Clinical grades C2-C6 on the CEAP system
* Superficial axial incompetence with proposed treatment lengths of at least 10cm
* Treatment with either endovenous laser ablation or mechanochemical ablation is technically feasible in the view of an experienced endovenous specialist
* Patient is willing to participate (including acceptance of randomisation to either treatment) and give valid, informed consent in the English language

Exclusion Criteria:

* One of the treatments is thought to be preferable by either the patient or an experienced endovenous specialist
* Unwilling or inability to comply with the requirements for follow-up visits
* Known allergy to medications or dressings used in the treatment
* Known right to left circulatory shunt
* Evidence of acute deep venous thrombosis or complete ipsilateral occlusion
* Pelvic vein insufficiency
* Active or recent thrombophlebitis (within 6 weeks)
* Impalpable foot pulses with an Ankle-Brachial Pressure Index of less than 0.8
* Pregnancy or breast feeding
* Active malignancy
* Immobility
* Involvement in other CTIMP trials within the last 6 months
C: Inclusion Criteria:

* Primary, symptomatic, varicose veins.
* Isolated Saphenofemoral junction (SFJ) incompetence leading to long saphenous (LSV) reflux on duplex ultrasound.
* LSV of 4mm diameter at the knee.
* Ability to give informed written consent.

Exclusion Criteria:

* Inability to give informed written consent.
* Symptomatic or complicated varicose veins not attributable to SFJ/LSV reflux.
* Evidence of deep venous reflux on duplex scan.
D: Inclusion Criteria:

1. Enrolled in the VeClose study.
2. Able and willing to complete the required 5 year study visit including Duplex ultrasound exam.
3. Able and willing to provide written informed consent prior to study specific data collection.

Exclusion Criteria:

1. Withdrew consent from the VeClose study.

Answer: C