Status:
UNKNOWN
MIcronized Flavonoid Fraction After MechanO-Chemical Ablation
Lead Sponsor:
Belarusian State Medical University
Conditions:
Varicose Veins
Surgery
Eligibility:
All Genders
18-80 years
Brief Summary
This study will be evaluate the clinical efficacy of micronized purified flavonoid fraction (MPFF) phlebotropic therapy for postoperative pain, venospecific symptoms, and quality of life in patients w...
Detailed Description
The pre-op examination involved taking patient history (including the information about prior venous surgeries), identifying varicose veins (VV's) clinical symptoms/signs, duplex ultrasound (US) evalu...
Eligibility Criteria
Inclusion
- Great and small saphenous vein (GSV/SSV) incompetence with reflux at least down to the knee level.
- Primary symptomatic varicose veins, Clinical Etiological Anatomical Pathophysiological (CEAP) classification, clinical class C2-C4.
- Physical status according to American Society of Anesthesiologists (ASA) I-II (I-Healthy, non-smoking, no or minimal alcohol use; II-Mild diseases only without substantive functional limitations).
- Ability to comprehend and sign an informed consent document.
Exclusion
- Postoperative varicose veins disease recurrence.
- Deep venous thrombosis, thrombophilia associated with a high risk of deep venous thrombosis or postthrombotic syndrome.
- Arterial occlusive disease more severe than Intermittent claudication after more than 200 meters of pain free walking (Fontaine IIA) and/or ankle brachial index below 0.8.
- 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 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04434274
Start Date
January 1 2019
End Date
December 31 2022
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