MechanO-Chemical Ablation Versus CompreSSion (MOCASS)

Belarusian State Medical University

Status: Unknown

Conditions: Surgery; Varicose Veins

Treatments: Device: Endovenous Mechano- Chemical Ablation

Study type: Observational

Funder types: Other

Identifiers

NCT04441957

20140456

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient age > 18 years.
2. Current leg ulceration of greater than 6 weeks.
3. Great saphenous vein (GSV) incompetence with reflux at least down to the knee level.
4. Primary symptomatic varicose veins, Clinical Etiological Anatomical Pathophysiological (CEAP) classification, clinical class C6.
5. Able to give informed consent to participate in the study after reading the patient information documentation.
6. Ankle Brachial Pressure Index (ABPI) ≥ 0.8.

Exclusion criteria

1. Postoperative varicose veins disease recurrence.
2. Patients who are unable to tolerate any multilayer compression bandaging / stockings will be excluded.
3. Deep venous thrombosis, thrombophilia associated with a high risk of deep venous thrombosis or postthrombotic syndrome.
4. History of pulmonary embolism or stroke.
5. Current anticoagulation therapy (within 7 days of enrollment).
6. Pregnant or lactating women.

Trial design

50 participants in 2 patient groups

Group A, MOCA-group

Description:

Procedure/Surgery: MOCA Mechano-Chemical Ablation plus Elastic Compression

Treatment:

Device: Endovenous Mechano- Chemical Ablation

Group B, Elastic Compression only group

Description:

Treatment: Elastic Compression only