MechanO-Chemical Ablation Versus CompreSSion

Study Overview
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Brief Summary
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This study will be looking at the effect of Endovenous Mechano-Chemical Ablation (MOCA) in addition to multilayer elastic compression bandaging vs multilayer elastic compression bandaging only in patients with incompetent great saphenous vein (GSV) and venous ulcers (VU's).

Detailed Description
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The most severe form of chronic venous disease is venous ulceration with an overall prevalence of about 1% in the adult population. Venous ulcers significantly impair quality of life, and their treatment places a heavy financial burden upon healthcare systems. To get the ulcer to heal, the current best treatment is to wear a compression bandage with multiple layers, with which about 60% of these ulcers will heal within 6 months. There is evidence that treatment of the varicose veins by sahenous veins stripping will prevent the ulcer recurrence. Recent studies have suggested that novel proceduress of superficial truncal reflux elimination, such as foam sclerotherapy or treating the saphenous veins with termal (laser or radiofrequency) ablation to seal it effectively, may help the ulcers to heal more quickly and increase recurrence-free rate. These techniques can be carried out in the outpatient setting and are much better tolerated by patients in comparison to surgery. At the same time, no studies which compared compression plus endovenous mechanochemical ablation (MOCA) vs. compression alone in chronic venous ulcers have been conducted to date. The aim of this study is to see whether treatment of varicose veins using MOCA helps with healing.

Official Title
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Endovenous MechanO-Chemical Ablation Plus Compression Versus CompreSSion Alone in Chronic Venous Ulcers Treatment

Conditions
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Varicose Veins, Surgery

Intervention / Treatment
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* Device: Endovenous Mechano- Chemical Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient age > 18 years. Current leg ulceration of greater than 6 weeks. Great saphenous vein (GSV) incompetence with reflux at least down to the knee level. Primary symptomatic varicose veins, Clinical Etiological Anatomical Pathophysiological (CEAP) classification, clinical class C6. Able to give informed consent to participate in the study after reading the patient information documentation. Ankle Brachial Pressure Index (ABPI) ≥ 0.8. Exclusion Criteria: Postoperative varicose veins disease recurrence. Patients who are unable to tolerate any multilayer compression bandaging / stockings will be excluded. Deep venous thrombosis, thrombophilia associated with a high risk of deep venous thrombosis or postthrombotic syndrome. History of pulmonary embolism or stroke. Current anticoagulation therapy (within 7 days of enrollment). Pregnant or lactating women.

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A, MOCA-group<br>Procedure/Surgery: MOCA Mechano-Chemical Ablation plus Elastic Compression | Device: Endovenous Mechano- Chemical Ablation<br>* The Flebogrif™ catheter (Balton® Sp. z o.o., Warsaw, Poland) represents endoluminal Non Thermal Non Tumescent devices designed to cause occlusion (fibrosis) of the target vein through the combined mechanical and chemical damage to its endothelial lining with retractable cutters and foamed sclerosant.<br>* Other names: MOCA;|
| Group B, Elastic Compression only group<br>Treatment: Elastic Compression only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with varicose Veins from absent (score 0) to severe (score 3). | None (0), Few, scattered (1), Confined to calf or thigh (2) Involve calf and thigh (3) | 6-12 months | 
| Number of Participants with skin Pigmentation from absent (score 0) to severe (score 3). | None (0), Limited to perimalleolar area (1), Diffuse over lower third of calf (2), Wider distribution (above lower third of calf) (3) | 6-12 months | 
| Number of Participants with induration from absent (score 0) to severe (score 3). | None (0), Limited to perimalleolar area (1), Involving lower third of calf (2), Involving more than lower third of calf (3) | 6-12 months | 
| Number of Participants with active ulcers from absent (score 0) to severe (score 3). | None (0), 1 (1), 2 (2), more than 2 (3) | 6-12 months | 
| Number of Participants with active ulcer diameter from absent (score 0) to severe (score 3). | None (0), Diameter less than 2 cm (1), Diameter 2-6 cm (2), Diameter more than 6 cm (3) | 6-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with ulcer recurrence-free rate (no - score 0, yes - score 1) | None (0), Less than 3 months (1), More than 3 months but less than 1 year (2) More than 1year (3) | 3-24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VV, MOCA, GSV, Venous Ulcers