Status:
UNKNOWN
MechanO-Chemical Ablation Versus CompreSSion
Lead Sponsor:
Belarusian State Medical University
Collaborating Sponsors:
Medical University of Warsaw
Conditions:
Varicose Veins
Surgery
Eligibility:
All Genders
18-80 years
Brief Summary
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 pati...
Detailed 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 treatm...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04441957
Start Date
January 1 2018
End Date
December 31 2021
Last Update
November 16 2021
Active Locations (1)
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1
Educational Institution "Belarusian State Medical University"
Minsk, Dzerzhinski Ave., 83,, Belarus, 220116