NCT04434274

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 18, 2021

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

November 16, 2021

Status Verified

November 1, 2021

Enrollment Period

2.5 years

First QC Date

June 10, 2020

Last Update Submit

November 13, 2021

Conditions

Varicose VeinsSurgery

Keywords

VVMPPFMOCAQoL

Outcome Measures

Primary Outcomes (12)

  • Number of Participants with pain from absent (score 0) to severe (score 3)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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 Outcomes (1)

  • Responders to Treatment, Assessed by Duplex Ultrasound

    8 weeks

Study Arms (2)

Group A, MPFF-group

MPFF \[Detralex®, Servier, France\] 1,000 mg OD for 30 days in the postoperative period.

Drug: Micronized Purified Flavonoid Fraction

Group B

No venoactive drug prescribed in the postoperative period.

Interventions

Micronized Purified Flavonoid FractionDRUG

Based on the (non-)use of adjuvant phlebotropic therapy in the postoperative period.

Also known as: Endovenous Mechano-Chemical Ablation
Group A, MPFF-group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Educational Institution "Belarusian State Medical University"

Minsk, Dzerzhinski Ave., 83,, 220116, Belarus

RECRUITING

Related Publications (6)

  • 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: 31970659BACKGROUND

  • 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: 18004259BACKGROUND

  • 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: 22929677BACKGROUND

  • 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: 28945060BACKGROUND

  • 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: 31284708BACKGROUND

  • 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: 28811080BACKGROUND

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Vladimir Khryshchanovich, MD, Prof

    Educational Institution "Belarusian State Medical University"

    STUDY CHAIR

Central Study Contacts

Vladimir Khryshchanovich, MD, Prof

CONTACT

+375296245578vladimirkh77@mail.ru

Yuri Nebylitsin, MD

CONTACT

+375299694114nebylicin.uravgm@mail.ru

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 10, 2020

First Posted

June 16, 2020

Study Start

January 1, 2019

Primary Completion

June 18, 2021

Study Completion

December 31, 2022

Last Updated

November 16, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will share

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).

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
12.2020
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).

Locations

BE(1)