<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04434274</url>
  </required_header>
  <id_info>
    <org_study_id>20140455</org_study_id>
    <nct_id>NCT04434274</nct_id>
  </id_info>
  <brief_title>MIcronized Flavonoid Fraction After MechanO-Chemical Ablation</brief_title>
  <acronym>MIFFMOCA</acronym>
  <official_title>Efficacy of MIcronized Purified Flavonoid Fraction-Based Phlebotropic Therapy After Endovenous MechanO-Chemical Ablation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Belarusian State Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Belarusian State Medical University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be evaluate the clinical efficacy of micronized purified flavonoid fraction&#xD;
      (MPFF) phlebotropic therapy for postoperative pain, venospecific symptoms, and quality of&#xD;
      life in patients with incompetent great or small saphenous veins (GSV/SSV) following an&#xD;
      endovenous mechanochemical ablation procedure (MOCA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The pre-op examination involved taking patient history (including the information about prior&#xD;
      venous surgeries), identifying varicose veins (VV's) clinical symptoms/signs, duplex&#xD;
      ultrasound (US) evaluation of the lower extremities, clinical-etiological and&#xD;
      anatomical-pathophysiological assessment based on the CEAP classification.&#xD;
&#xD;
      The primary transverse and longitudinal US examination (B-mode, color and spectral Doppler)&#xD;
      was performed by expert doctors at the Vascular Pathology Non-Invasive Diagnostics Unit&#xD;
      before deciding on treatment choices. Reflux in the saphenofemoral/saphenopopliteal junction&#xD;
      (SFJ/SPJ) area was determined in supine and upright positions using the Valsalva manoeuvre or&#xD;
      manual compression/decompression test, respectively. SFJ/SPJ and great/small saphenous vein&#xD;
      (GSV/SSV) segments with retrograde blood flow longer than 0.5 seconds were considered&#xD;
      incompetent. Venous reflux section length and incompetent GSV/SSV segments' diameter (in mm)&#xD;
      were reflected in medical documentation.&#xD;
&#xD;
      The trial inclusion criteria were as follows: age &gt;18 years old; VV's CEAP clinical class&#xD;
      C2-C4; SFJ/SPJ insufficiency and pathological (&gt;0.5 s) reflux in GSV/SSV manifested by one or&#xD;
      more &quot;venous&quot; symptoms (pain, itching, nocturnal leg cramps, swelling/pulsing sensation,&#xD;
      heaviness, fatigue and overall discomfort), vein diameter at the SFJ/SPJ &gt;4.5 mm and &lt;8 mm in&#xD;
      an upright position.&#xD;
&#xD;
      The patients were informed about the MOCA technique, the intervention's potential&#xD;
      complications and side effects.&#xD;
&#xD;
      The exclusion criteria included isolated reflux in tributaries, excessive GSV/SSV tortuosity,&#xD;
      known allergy to the sclerosant, deep/superficial vein thrombosis, post-thrombotic occlusion,&#xD;
      confirmed thrombophilia, postoperative VV recurrence, obliterating peripheral artery diseases&#xD;
      (ankle-brachial pressure index &lt;0.8), pregnancy and lactation.&#xD;
&#xD;
      The Flebogrif™ device's design is based on a 5Fr single-channel diagnostic vascular catheter&#xD;
      60 cm or 90 cm long (with 1-cm graduated marks), its lumen containing a retractable metal rod&#xD;
      with five sharp wires (&quot;claws&quot;) attached to its tip. As the &quot;claws&quot; get released and the&#xD;
      catheter is then withdrawn from the vessel, the vein wall's endothelial layer gets damaged;&#xD;
      at this time, the distance between the fully opened cutting elements is ~29 mm, which is&#xD;
      quite enough to treat incompetent veins up to 17-20 mm in diameter.&#xD;
&#xD;
      The patients were put in supine or prone positions for GSV or SSV ablation, respectively. The&#xD;
      catheter length choice was determined by that of the incompetent vein segment. The GSV/SSV&#xD;
      was punctured with a straight needle 18G at the distal point of reflux in an operating room&#xD;
      under local anesthesia (1% lidocaine hydrochloride solution) and US guidance, after which a&#xD;
      0.035&quot; J-shape guidewire was employed to insert a 6Fr introducer with an expander. Upon the&#xD;
      latter's removal, a Flebogrif™ catheter was delivered to the target vein's lumen so as to&#xD;
      have its tip positioned 2-3 cm below the SFJ/SPJ. Following the guidewire's removal, the&#xD;
      catheter's cutting elements were released, shifting its outer &quot;shell&quot; against the stationary&#xD;
      inner rod, after which a syringe containing a dose of 3% lauromacrogol-400 foamed solution&#xD;
      (Ethoxysclerol®, Kreussler &amp; Co. GmbH, Wiesbaden, Germany) prepared using the Tessari's&#xD;
      method was connected to the central channel's port. The catheter was being distally removed&#xD;
      from the vein in a smooth motion all the way up to the introducer, damaging the endothelium&#xD;
      with its cutters, with simultaneous introduction of the foam in the amount of 0.1-0.2 ml per&#xD;
      1 cm. The graduated marks on the catheter helped measure the treated GSV/SSV section's&#xD;
      length. During and within 5 minutes after the foam injection, the ultrasound probe was used&#xD;
      to apply percutaneous compression in the SFJ/SPJ plane. Where deemed necessary, MOCA was&#xD;
      supplemented with simultaneous Müller- Varadi miniphlebectomy or standard foam sclerotherapy&#xD;
      of the visible varicose tributaries.&#xD;
&#xD;
      Immediately after the procedure, a class 2 RAL compression stocking was put on the operated&#xD;
      lower limb, and the patients were recommended a 30-minute walk. The duration of elastic&#xD;
      compression was continuous over the first 24 hours, with subsequent transition to daytime&#xD;
      wear for 4 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">June 18, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with pain from absent (score 0) to severe (score 3)</measure>
    <time_frame>7 days</time_frame>
    <description>None (0), Occasional (1), Daily, interfering with, but not preventing regular daily activities (2), Daily, limiting most regular daily activities (3)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with pain from absent (score 0) to severe (score 3)</measure>
    <time_frame>14 days</time_frame>
    <description>None (0), Occasional (1), Daily, interfering with, but not preventing regular daily activities (2), Daily, limiting most regular daily activities (3)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with pain from absent (score 0) to severe (score 3)</measure>
    <time_frame>30 days</time_frame>
    <description>None (0), Occasional (1), Daily, interfering with, but not preventing regular daily activities (2), Daily, limiting most regular daily activities (3)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with other discomfort (ie aching, heaviness, fatigue, soreness, burning) from absent (score 0) to severe (score 3)</measure>
    <time_frame>7 days</time_frame>
    <description>None (0), Occasional (1), Daily, interfering with, but not preventing regular daily activities (2), Daily, limiting most regular daily activities (3)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with other discomfort (ie aching, heaviness, fatigue, soreness, burning) from absent (score 0) to severe (score 3)</measure>
    <time_frame>14 days</time_frame>
    <description>None (0), Occasional (1), Daily, interfering with, but not preventing regular daily activities (2), Daily, limiting most regular daily activities (3)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with other discomfort (ie aching, heaviness, fatigue, soreness, burning) from absent (score 0) to severe (score 3)</measure>
    <time_frame>30 days</time_frame>
    <description>None (0), Occasional (1), Daily, interfering with, but not preventing regular daily activities (2), Daily, limiting most regular daily activities (3)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with venous oedema from absent (score 0) to severe (score 3)</measure>
    <time_frame>7 days</time_frame>
    <description>None (0), Limited to foot or ankle (1), Extends above ankle but below knee (2), Extends to knee or above (3)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with venous oedema from absent (score 0) to severe (score 3)</measure>
    <time_frame>14 days</time_frame>
    <description>None (0), Limited to foot or ankle (1), Extends above ankle but below knee (2), Extends to knee or above (3)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with venous oedema from absent (score 0) to severe (score 3)</measure>
    <time_frame>30 days</time_frame>
    <description>None (0), Limited to foot or ankle (1), Extends above ankle but below knee (2), Extends to knee or above (3)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with inflammation from absent (score 0) to severe (score 3)</measure>
    <time_frame>7 days</time_frame>
    <description>None (0), Limited to paramalleolar area (1), Diffuse over lower third of calf (2), Wider distribution (above lower third of calf) (3)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with inflammation from absent (score 0) to severe (score 3)</measure>
    <time_frame>14 days</time_frame>
    <description>None (0), Limited to paramalleolar area (1), Diffuse over lower third of calf (2), Wider distribution (above lower third of calf) (3)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with inflammation from absent (score 0) to severe (score 3)</measure>
    <time_frame>30 days</time_frame>
    <description>None (0), Limited to paramalleolar area (1), Diffuse over lower third of calf (2), Wider distribution (above lower third of calf) (3)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Responders to Treatment, Assessed by Duplex Ultrasound</measure>
    <time_frame>8 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Varicose Veins</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Group A, MPFF-group</arm_group_label>
    <description>MPFF [Detralex®, Servier, France] 1,000 mg OD for 30 days in the postoperative period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <description>No venoactive drug prescribed in the postoperative period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Micronized Purified Flavonoid Fraction</intervention_name>
    <description>Based on the (non-)use of adjuvant phlebotropic therapy in the postoperative period.</description>
    <arm_group_label>Group A, MPFF-group</arm_group_label>
    <other_name>Endovenous Mechano-Chemical Ablation</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with GSV/SSV incompetence and C2-C4 were included in in the prospective&#xD;
        consecutive case study if they satisfied the selection criteria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Great and small saphenous vein (GSV/SSV) incompetence with reflux at least down to the&#xD;
             knee level.&#xD;
&#xD;
          2. Primary symptomatic varicose veins, Clinical Etiological Anatomical Pathophysiological&#xD;
             (CEAP) classification, clinical class C2-C4.&#xD;
&#xD;
          3. Physical status according to American Society of Anesthesiologists (ASA) I-II&#xD;
             (I-Healthy, non-smoking, no or minimal alcohol use; II-Mild diseases only without&#xD;
             substantive functional limitations).&#xD;
&#xD;
          4. Ability to comprehend and sign an informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Postoperative varicose veins disease recurrence.&#xD;
&#xD;
          2. Deep venous thrombosis, thrombophilia associated with a high risk of deep venous&#xD;
             thrombosis or postthrombotic syndrome.&#xD;
&#xD;
          3. Arterial occlusive disease more severe than Intermittent claudication after more than&#xD;
             200 meters of pain free walking (Fontaine IIA) and/or ankle brachial index below 0.8.&#xD;
&#xD;
          4. History of pulmonary embolism or stroke.&#xD;
&#xD;
          5. Current anticoagulation therapy (within 7 days of enrollment).&#xD;
&#xD;
          6. Pregnant or lactating women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vladimir Khryshchanovich, MD, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Educational Institution &quot;Belarusian State Medical University&quot;</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Vladimir Khryshchanovich, MD, Prof</last_name>
    <phone>+375296245578</phone>
    <email>vladimirkh77@mail.ru</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yuri Nebylitsin, MD</last_name>
    <phone>+375299694114</phone>
    <email>nebylicin.uravgm@mail.ru</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Educational Institution &quot;Belarusian State Medical University&quot;</name>
      <address>
        <city>Minsk</city>
        <state>Dzerzhinski Ave., 83,</state>
        <zip>220116</zip>
        <country>Belarus</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Varvara Boika</last_name>
      <phone>+ 375 17 277-16-72</phone>
      <email>intdept@bsmu.by</email>
    </contact>
  </location>
  <location_countries>
    <country>Belarus</country>
  </location_countries>
  <reference>
    <citation>Nicolaides AN. The Benefits of Micronized Purified Flavonoid Fraction (MPFF) Throughout the Progression of Chronic Venous Disease. Adv Ther. 2020 Feb;37(Suppl 1):1-5. doi: 10.1007/s12325-019-01218-8. Epub 2020 Jan 22.</citation>
    <PMID>31970659</PMID>
  </reference>
  <reference>
    <citation>Pokrovsky AV, Saveljev VS, Kirienko AI, Bogachev VY, Zolotukhin IA, Sapelkin SV, Shvalb PG, Zhukov BN, Vozlubleny SI, Sabelnikov VV, Voskanian YE, Katelnitsky II, Burleva EP, Tolstikhin VY. Surgical correction of varicose vein disease under micronized diosmin protection (results of the Russian multicenter controlled trial DEFANS). Angiol Sosud Khir. 2007;13(2):47-55. English, Russian.</citation>
    <PMID>18004259</PMID>
  </reference>
  <reference>
    <citation>Bogachev VIu, Golovanova OV, Kuzhetsov AN, Shekoian AO. [On advisability of perioperative phleboprotection in endovascular treatment of lower in varicose disease: first initial results of the decision study]. Angiol Sosud Khir. 2012;18(2):90-5. Russian.</citation>
    <PMID>22929677</PMID>
  </reference>
  <reference>
    <citation>Bogachev VY, Boldin BV, Lobanov VN. Benefits of micronized purified flavonoid fraction as adjuvant therapy on inflammatory response after sclerotherapy. Int Angiol. 2018 Feb;37(1):71-78. doi: 10.23736/S0392-9590.17.03868-8. Epub 2017 Sep 22.</citation>
    <PMID>28945060</PMID>
  </reference>
  <reference>
    <citation>Mansilha A, Sousa J. Benefits of venoactive drug therapy in surgical or endovenous treatment for varicose veins: a systematic review. Int Angiol. 2019 Aug;38(4):291-298. doi: 10.23736/S0392-9590.19.04216-0. Epub 2019 Jul 5.</citation>
    <PMID>31284708</PMID>
  </reference>
  <reference>
    <citation>Sun JJ, Chowdhury MM, Sadat U, Hayes PD, Tang TY. Mechanochemical Ablation for Treatment of Truncal Venous Insufficiency: A Review of the Current Literature. J Vasc Interv Radiol. 2017 Oct;28(10):1422-1431. doi: 10.1016/j.jvir.2017.07.002. Epub 2017 Aug 12.</citation>
    <PMID>28811080</PMID>
  </reference>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>November 13, 2021</last_update_submitted>
  <last_update_submitted_qc>November 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Belarusian State Medical University</investigator_affiliation>
    <investigator_full_name>Vladimir Khryshchanovich</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>VV</keyword>
  <keyword>MPPF</keyword>
  <keyword>MOCA</keyword>
  <keyword>QoL</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Varicose Veins</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_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_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>12.2020</ipd_time_frame>
    <ipd_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_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04434274
org study id: 20140455
nct id: NCT04434274
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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).
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.
observational model: Cohort
time perspective: Prospective
measure: Number of Participants with pain from absent (score 0) to severe (score 3)
time frame: 7 days
description: None (0), Occasional (1), Daily, interfering with, but not preventing regular daily activities (2), Daily, limiting most regular daily activities (3)
measure: Number of Participants with pain from absent (score 0) to severe (score 3)
time frame: 14 days
description: None (0), Occasional (1), Daily, interfering with, but not preventing regular daily activities (2), Daily, limiting most regular daily activities (3)
measure: Number of Participants with pain from absent (score 0) to severe (score 3)
time frame: 30 days
description: None (0), Occasional (1), Daily, interfering with, but not preventing regular daily activities (2), Daily, limiting most regular daily activities (3)
measure: Number of Participants with other discomfort (ie aching, heaviness, fatigue, soreness, burning) from absent (score 0) to severe (score 3)
time frame: 7 days
description: None (0), Occasional (1), Daily, interfering with, but not preventing regular daily activities (2), Daily, limiting most regular daily activities (3)
measure: Number of Participants with other discomfort (ie aching, heaviness, fatigue, soreness, burning) from absent (score 0) to severe (score 3)
time frame: 14 days
description: None (0), Occasional (1), Daily, interfering with, but not preventing regular daily activities (2), Daily, limiting most regular daily activities (3)
measure: Number of Participants with other discomfort (ie aching, heaviness, fatigue, soreness, burning) from absent (score 0) to severe (score 3)
time frame: 30 days
description: None (0), Occasional (1), Daily, interfering with, but not preventing regular daily activities (2), Daily, limiting most regular daily activities (3)
measure: Number of Participants with venous oedema from absent (score 0) to severe (score 3)
time frame: 7 days
description: None (0), Limited to foot or ankle (1), Extends above ankle but below knee (2), Extends to knee or above (3)
measure: Number of Participants with venous oedema from absent (score 0) to severe (score 3)
time frame: 14 days
description: None (0), Limited to foot or ankle (1), Extends above ankle but below knee (2), Extends to knee or above (3)
measure: Number of Participants with venous oedema from absent (score 0) to severe (score 3)
time frame: 30 days
description: None (0), Limited to foot or ankle (1), Extends above ankle but below knee (2), Extends to knee or above (3)
measure: Number of Participants with inflammation from absent (score 0) to severe (score 3)
time frame: 7 days
description: None (0), Limited to paramalleolar area (1), Diffuse over lower third of calf (2), Wider distribution (above lower third of calf) (3)
measure: Number of Participants with inflammation from absent (score 0) to severe (score 3)
time frame: 14 days
description: None (0), Limited to paramalleolar area (1), Diffuse over lower third of calf (2), Wider distribution (above lower third of calf) (3)
measure: Number of Participants with inflammation from absent (score 0) to severe (score 3)
time frame: 30 days
description: None (0), Limited to paramalleolar area (1), Diffuse over lower third of calf (2), Wider distribution (above lower third of calf) (3)
measure: Responders to Treatment, Assessed by Duplex Ultrasound
time frame: 8 weeks
description: 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.
arm group label: Group A, MPFF-group
description: MPFF [Detralex®, Servier, France] 1,000 mg OD for 30 days in the postoperative period.
arm group label: Group B
description: No venoactive drug prescribed in the postoperative period.
intervention type: Drug
intervention name: Micronized Purified Flavonoid Fraction
description: Based on the (non-)use of adjuvant phlebotropic therapy in the postoperative period.
arm group label: Group A, MPFF-group
other name: Endovenous Mechano-Chemical Ablation
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Vladimir Khryshchanovich, MD, Prof
role: Study Chair
affiliation: Educational Institution "Belarusian State Medical University"
last name: Vladimir Khryshchanovich, MD, Prof
phone: +375296245578
email: vladimirkh77@mail.ru
last name: Yuri Nebylitsin, MD
phone: +375299694114
email: nebylicin.uravgm@mail.ru
facility: 
status: Recruiting
contact: 
country: Belarus
citation: Nicolaides AN. The Benefits of Micronized Purified Flavonoid Fraction (MPFF) Throughout the Progression of Chronic Venous Disease. Adv Ther. 2020 Feb;37(Suppl 1):1-5. doi: 10.1007/s12325-019-01218-8. Epub 2020 Jan 22.
PMID: 31970659
citation: Pokrovsky AV, Saveljev VS, Kirienko AI, Bogachev VY, Zolotukhin IA, Sapelkin SV, Shvalb PG, Zhukov BN, Vozlubleny SI, Sabelnikov VV, Voskanian YE, Katelnitsky II, Burleva EP, Tolstikhin VY. Surgical correction of varicose vein disease under micronized diosmin protection (results of the Russian multicenter controlled trial DEFANS). Angiol Sosud Khir. 2007;13(2):47-55. English, Russian.
PMID: 18004259
citation: Bogachev VIu, Golovanova OV, Kuzhetsov AN, Shekoian AO. [On advisability of perioperative phleboprotection in endovascular treatment of lower in varicose disease: first initial results of the decision study]. Angiol Sosud Khir. 2012;18(2):90-5. Russian.
PMID: 22929677
citation: Bogachev VY, Boldin BV, Lobanov VN. Benefits of micronized purified flavonoid fraction as adjuvant therapy on inflammatory response after sclerotherapy. Int Angiol. 2018 Feb;37(1):71-78. doi: 10.23736/S0392-9590.17.03868-8. Epub 2017 Sep 22.
PMID: 28945060
citation: Mansilha A, Sousa J. Benefits of venoactive drug therapy in surgical or endovenous treatment for varicose veins: a systematic review. Int Angiol. 2019 Aug;38(4):291-298. doi: 10.23736/S0392-9590.19.04216-0. Epub 2019 Jul 5.
PMID: 31284708
citation: Sun JJ, Chowdhury MM, Sadat U, Hayes PD, Tang TY. Mechanochemical Ablation for Treatment of Truncal Venous Insufficiency: A Review of the Current Literature. J Vasc Interv Radiol. 2017 Oct;28(10):1422-1431. doi: 10.1016/j.jvir.2017.07.002. Epub 2017 Aug 12.
PMID: 28811080
responsible party type: Principal Investigator
investigator affiliation: Belarusian State Medical University
investigator full name: Vladimir Khryshchanovich
investigator title: Professor
mesh term: Varicose Veins
sharing ipd: Yes
ipd 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 info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: 12.2020
ipd 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).