Compression Stockings Therapy Following Mechano-Chemical Ablation (Clarivein®)

Study Overview
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Brief Summary
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This study will be looking at the effect of compression therapy in patients having Mechano-Chemical Ablation (MOCA) therapy for truncal incompetence of their varicose veins using the ClariVein® device. Patients will be randomised to either the compression group (group A) or the no compression group (group B). The pain scores, compliance, quality of life scores, occlusion rate at 6 months as well as the cost effectiveness of each intervention will be assessed.

Detailed Description
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Varicose veins are common and are known to affect approximately one third of the population. Chronic Venous Disease (CVD) has been shown to have a negative impact on the quality of life of patients and treatment of varicose veins has been demonstrated to lead to improvement in the quality of life of patients. Over the past decade, new endovenous techniques have been introduced and these are felt to be cost-effective, especially, when performed in an outpatient or 'office-based' setting. There is currently uncertainty about the use of compression stockings following treatment of varicose veins. International Union of Phlebology (IUP), The Society for Vascular Surgery and the American Venous Forum, as well as 2013 National Institute for Health and Care Excellence (NICE) Guideline on Varicose Veins in the Legs have recommended that compression stockings are suitable in certain clinical indications and can be worn post-operatively for no more than 7 days after interventional treatment to prevent haematoma formation, pain and swelling. However, further research is essential for determining clinical and cost effectiveness, as well as length of time compression should be worn, and level of compression. Several researchers have looked into the practice of using compression after venous ablation. In a survey of the management of varicose veins by the members of the Vascular Society of Great Britain and Ireland. Edwards et al. found that the majority of surgeons used bandages post-operatively, with 49% using elastic bandage. To date, the literature on the use of compression stockings following treatment of varicose veins is limited. Mechano-Chemical Ablation (MOCA) combines mechanical damage to the endothelium caused by a rotating wire with simultaneous catheter-guided infusion of a liquid sclerosant that irreversibly damages the cellular membrane of the endothelium, causing fibrosis of the vein. The exact mechanism is still not exactly known. However, recent experimental research showed that various sclerosants induced apoptosis in the vein wall rather than having an effect restricted to the endothelium. Incomplete loss of endothelial cells and penetration of the sclerosant effect into the media suggest that medial damage is crucial to the success of sclerotherapy and may explain why it is less effective in larger veins. This poses the question whether compression is needed post sclerotherapy to improve contact of the sclerosant to the endothelium when media penetration seems to be more important to allow apoptosis of smooth muscle cells. The investigators therefore propose to undertake a randomised study looking at the effect of compression therapy after MOCA using Clarivein device

Official Title
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A Randomised Controlled Trial of Compression Stockings Therapy Following Mechano-Chemical Ablation

Conditions
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Varicose Veins, Chronic Venous Insufficiency

Intervention / Treatment
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* Other: Compression Stockings


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age>=21 to <=80 Able to walk unassisted and attend follow-up visits Symptomatic Great Saphenous Vein (GSV) or Small Saphenous Vein (SSV) vein reflux >0.5 seconds on colour Duplex ultrasound Able to provide informed consent Exclusion Criteria: Previous or current deep vein thrombosis or pulmonary embolism Patients with a hypercoaguable state Previous thrombophlebitis in the truncal vein in question, which had recanalized and was now incompetent on duplex ultrasound Recurrent varicose vein i.e. patients who have had treatment previously in the designated truncal vein with any modality Patients who have had treatment in either leg for an incompetent saphenous truncal vein less than 3 months prior to treatment and enrolment into this study Patients requiring adjuvant treatment of varicose veins Arterial disease (ABPI < 0.6 and the absence of a palpable pedal pulse) Vein diameter <3mm or >12mm as measured in the standing position on duplex ultrasound Varicose veins unsuitable for MOCA (e.g. very tortuous vein) Pregnancy Lycra, sclerosant or local anaesthetic allergy Patients who have opted for an alternative method of treatment Patients with fibromyalgia Patients with Clinical, Etiologic, Anatomic and Pathophysiologic (CEAP) score of C6 (active ulcer), C1 and C2 (asymptomatic) disease Patients with a life expectancy less than 12 months Inability or unwillingness to complete questionnaires Patients who refuses to participate and unable to provide informed consent or comply with the study protocol.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Compression<br>Patient will receive Class II above knee compression stockings, and will be asked to wear it for 1 week. This would involve wearing the stocking during daytime but patients will be allowed to take it off at night whilst in bed. | Other: Compression Stockings<br>* Class II above knee compression stockings<br>|
| No Intervention: No Compression<br>Patient will not receive any compression stockings. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score post-procedure | Participants will record their pain score using the Visual Analogue Score (VAS) for pain. The scale ranges from 0 (no pain) to 10 (worst pain imaginable). | First 10 days post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life score using the EQ-5D questionnaire | EQ-5D is used to assess quality of life based on Mobility, Self-care, Usual Activities, Pain/Discomfort and Anxiety, rated at 5 levels: no problems, slight problems, moderate problems, severe problems, unable to perform activity. Inputs from this questionnaire is used to observe for changes in quality of life overtime | Baseline, 2 weeks post-op, 6 months post-op | 
| Quality of life score using the Chronic Venous Insufficiency Questionnaire (CIVIQ) | CIVIQ-14 is a questionnaire based on three dimensions - pain, physical and psychological, based on a scale from 1 to 5 (no trouble, slight, moderate, considerable, severe). Based on inputs, Global Index Score (GIS) will be tabulated, ranging from 0 to 100 - the higher the value, the poorer the quality of life. | Baseline, 2 weeks post-op, 6 months post-op | 
| Quality of life score using the Aberdeen Varicose Veins Questionnaire (AVVQ) | To measure health status of varicose vein patients based on symptoms and impact on daily activities. A total score ranging from 0 to 100 will be tabulated, with 100 being worst quality of life | Baseline, 2 weeks post-op, 6 months post-op | 
| Clinical Change using Venous Clinical Severity Score (VCSS) | VCSS evaluates the severity of hallmarks of venous disease - 0 (none), 1 (Mild) , 2(Moderate), 3 (Severe). | Baseline, 2 weeks post-op, 6 months post-op | 
| Time taken to return to work and normal activities |  | 10 days post-op | 
| Degree of bruising and phlebitis | Assessed using a pre-determined score (0=0%; 1= <25% of treated vein affected; 2 = 25-50% ; 3 = 50-75%; 4 = 75-100% and 5 = extending beyond the treated vein | 2 weeks post-op, 6 months post-op | 
| The number of patient compliant with the intervention |  | 10 days post-op | 
| Patient's satisfaction | To rate satisfaction with overall teatment regime with a numerical scale of 0 (least satisfied) to 10 (most satisfied) | 2 weeks post-op, 6 months post-op | 
| Comparison of the cost-effectiveness of the intervention | Analyze cost and patient outcomes to determine effectiveness of interventions | 6 months post-op | 
| Successful obliteration of target vein | This is assessed by duplex ultrasound scan. Recanalization will be defined by a segment of vein greater than or equal to 5cm | 2 weeks post-op, 6 months post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mechano-chemical ablation, compression stockings