MIcronized Flavonoid Fraction After MechanO-Chemical Ablation (MIFFMOCA)

November 13, 2021 updated by: Vladimir Khryshchanovich, Belarusian State Medical University

Efficacy of MIcronized Purified Flavonoid Fraction-Based Phlebotropic Therapy After Endovenous MechanO-Chemical Ablation

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 with incompetent great or small saphenous veins (GSV/SSV) following an endovenous mechanochemical ablation procedure (MOCA).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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) evaluation of the lower extremities, clinical-etiological and anatomical-pathophysiological assessment based on the CEAP classification.

The primary transverse and longitudinal US examination (B-mode, color and spectral Doppler) was performed by expert doctors at the Vascular Pathology Non-Invasive Diagnostics Unit before deciding on treatment choices. Reflux in the saphenofemoral/saphenopopliteal junction (SFJ/SPJ) area was determined in supine and upright positions using the Valsalva manoeuvre or manual compression/decompression test, respectively. SFJ/SPJ and great/small saphenous vein (GSV/SSV) segments with retrograde blood flow longer than 0.5 seconds were considered incompetent. Venous reflux section length and incompetent GSV/SSV segments' diameter (in mm) were reflected in medical documentation.

The trial inclusion criteria were as follows: age >18 years old; VV's CEAP clinical class C2-C4; SFJ/SPJ insufficiency and pathological (>0.5 s) reflux in GSV/SSV manifested by one or more "venous" symptoms (pain, itching, nocturnal leg cramps, swelling/pulsing sensation, heaviness, fatigue and overall discomfort), vein diameter at the SFJ/SPJ >4.5 mm and <8 mm in an upright position.

The patients were informed about the MOCA technique, the intervention's potential complications and side effects.

The exclusion criteria included isolated reflux in tributaries, excessive GSV/SSV tortuosity, known allergy to the sclerosant, deep/superficial vein thrombosis, post-thrombotic occlusion, confirmed thrombophilia, postoperative VV recurrence, obliterating peripheral artery diseases (ankle-brachial pressure index <0.8), pregnancy and lactation.

The Flebogrif™ device's design is based on a 5Fr single-channel diagnostic vascular catheter 60 cm or 90 cm long (with 1-cm graduated marks), its lumen containing a retractable metal rod with five sharp wires ("claws") attached to its tip. As the "claws" get released and the catheter is then withdrawn from the vessel, the vein wall's endothelial layer gets damaged; at this time, the distance between the fully opened cutting elements is ~29 mm, which is quite enough to treat incompetent veins up to 17-20 mm in diameter.

The patients were put in supine or prone positions for GSV or SSV ablation, respectively. The catheter length choice was determined by that of the incompetent vein segment. The GSV/SSV was punctured with a straight needle 18G at the distal point of reflux in an operating room under local anesthesia (1% lidocaine hydrochloride solution) and US guidance, after which a 0.035" J-shape guidewire was employed to insert a 6Fr introducer with an expander. Upon the latter's removal, a Flebogrif™ catheter was delivered to the target vein's lumen so as to have its tip positioned 2-3 cm below the SFJ/SPJ. Following the guidewire's removal, the catheter's cutting elements were released, shifting its outer "shell" against the stationary inner rod, after which a syringe containing a dose of 3% lauromacrogol-400 foamed solution (Ethoxysclerol®, Kreussler & Co. GmbH, Wiesbaden, Germany) prepared using the Tessari's method was connected to the central channel's port. The catheter was being distally removed from the vein in a smooth motion all the way up to the introducer, damaging the endothelium with its cutters, with simultaneous introduction of the foam in the amount of 0.1-0.2 ml per 1 cm. The graduated marks on the catheter helped measure the treated GSV/SSV section's length. During and within 5 minutes after the foam injection, the ultrasound probe was used to apply percutaneous compression in the SFJ/SPJ plane. Where deemed necessary, MOCA was supplemented with simultaneous Müller- Varadi miniphlebectomy or standard foam sclerotherapy of the visible varicose tributaries.

Immediately after the procedure, a class 2 RAL compression stocking was put on the operated lower limb, and the patients were recommended a 30-minute walk. The duration of elastic compression was continuous over the first 24 hours, with subsequent transition to daytime wear for 4 weeks.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belarus
    • Dzerzhinski Ave., 83,
      • Minsk, Dzerzhinski Ave., 83,, Belarus, 220116
        • Recruiting
        • Educational Institution "Belarusian State Medical University"
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with GSV/SSV incompetence and C2-C4 were included in in the prospective consecutive case study if they satisfied the selection criteria

Description

Inclusion Criteria:

  1. Great and small saphenous vein (GSV/SSV) incompetence with reflux at least down to the knee level.
  2. Primary symptomatic varicose veins, Clinical Etiological Anatomical Pathophysiological (CEAP) classification, clinical class C2-C4.
  3. 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).
  4. Ability to comprehend and sign an informed consent document.

Exclusion Criteria:

  1. Postoperative varicose veins disease recurrence.
  2. Deep venous thrombosis, thrombophilia associated with a high risk of deep venous thrombosis or postthrombotic syndrome.
  3. 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.
  4. History of pulmonary embolism or stroke.
  5. Current anticoagulation therapy (within 7 days of enrollment).
  6. Pregnant or lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A, MPFF-group
MPFF [Detralex®, Servier, France] 1,000 mg OD for 30 days in the postoperative period.
Drug: Micronized Purified Flavonoid Fraction
Based on the (non-)use of adjuvant phlebotropic therapy in the postoperative period.
Other Names:
  • Endovenous Mechano-Chemical Ablation
Group B
No venoactive drug prescribed in the postoperative period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with pain from absent (score 0) to severe (score 3)
Time Frame: 7 days
None (0), Occasional (1), Daily, interfering with, but not preventing regular daily activities (2), Daily, limiting most regular daily activities (3)
7 days
Number of Participants with pain from absent (score 0) to severe (score 3)
Time Frame: 14 days
None (0), Occasional (1), Daily, interfering with, but not preventing regular daily activities (2), Daily, limiting most regular daily activities (3)
14 days
Number of Participants with pain from absent (score 0) to severe (score 3)
Time Frame: 30 days
None (0), Occasional (1), Daily, interfering with, but not preventing regular daily activities (2), Daily, limiting most regular daily activities (3)
30 days
Number of Participants with other discomfort (ie aching, heaviness, fatigue, soreness, burning) from absent (score 0) to severe (score 3)
Time Frame: 7 days
None (0), Occasional (1), Daily, interfering with, but not preventing regular daily activities (2), Daily, limiting most regular daily activities (3)
7 days
Number of Participants with other discomfort (ie aching, heaviness, fatigue, soreness, burning) from absent (score 0) to severe (score 3)
Time Frame: 14 days
None (0), Occasional (1), Daily, interfering with, but not preventing regular daily activities (2), Daily, limiting most regular daily activities (3)
14 days
Number of Participants with other discomfort (ie aching, heaviness, fatigue, soreness, burning) from absent (score 0) to severe (score 3)
Time Frame: 30 days
None (0), Occasional (1), Daily, interfering with, but not preventing regular daily activities (2), Daily, limiting most regular daily activities (3)
30 days
Number of Participants with venous oedema from absent (score 0) to severe (score 3)
Time Frame: 7 days
None (0), Limited to foot or ankle (1), Extends above ankle but below knee (2), Extends to knee or above (3)
7 days
Number of Participants with venous oedema from absent (score 0) to severe (score 3)
Time Frame: 14 days
None (0), Limited to foot or ankle (1), Extends above ankle but below knee (2), Extends to knee or above (3)
14 days
Number of Participants with venous oedema from absent (score 0) to severe (score 3)
Time Frame: 30 days
None (0), Limited to foot or ankle (1), Extends above ankle but below knee (2), Extends to knee or above (3)
30 days
Number of Participants with inflammation from absent (score 0) to severe (score 3)
Time Frame: 7 days
None (0), Limited to paramalleolar area (1), Diffuse over lower third of calf (2), Wider distribution (above lower third of calf) (3)
7 days
Number of Participants with inflammation from absent (score 0) to severe (score 3)
Time Frame: 14 days
None (0), Limited to paramalleolar area (1), Diffuse over lower third of calf (2), Wider distribution (above lower third of calf) (3)
14 days
Number of Participants with inflammation from absent (score 0) to severe (score 3)
Time Frame: 30 days
None (0), Limited to paramalleolar area (1), Diffuse over lower third of calf (2), Wider distribution (above lower third of calf) (3)
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Responders to Treatment, Assessed by Duplex Ultrasound
Time Frame: 8 weeks
Responders; elimination of reflux through the saphenofemoral/saphenopopliteal junctions and/or coplete occlusion of the great/small saphenous veins at 8 weeks, as measured by duplex ultrasound.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Belarusian State Medical University

Investigators

  • Study Chair: Vladimir Khryshchanovich, MD, Prof, Educational Institution "Belarusian State Medical University"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

June 18, 2021

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

June 10, 2020

First Submitted That Met QC Criteria

June 15, 2020

First Posted (Actual)

June 16, 2020

Study Record Updates

Last Update Posted (Actual)

November 16, 2021

Last Update Submitted That Met QC Criteria

November 13, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20140455

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

To evaluate clinical efficacy of micronized purified flavonoid fraction (MPFF) phlebotropic therapy for postoperative pain, venospecific symptoms, and quality of life in patients with varicose veins (VV) following an endovenous mechanochemical ablation procedure (MOCA).

IPD Sharing Time Frame

12.2020

IPD Sharing Access Criteria

To evaluate clinical efficacy of micronized purified flavonoid fraction (MPFF) phlebotropic therapy for postoperative pain, venospecific symptoms, and quality of life in patients with varicose veins (VV) following an endovenous mechanochemical ablation procedure (MOCA).

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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