Varicose VeinsMIFFMOCANCT04434274
MIcronized Flavonoid Fraction After MechanO-Chemical Ablation
An observational study of Varicose Veins and Surgery, run by Belarusian State Medical University at 1 site in Belarus.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Varicose Veins, Surgery
- What is being tested?
- Micronized Purified Flavonoid Fraction
- How many people
- 100 participants
- Where
- 1 siteBelarus
- Study dates
- 1 Jan 2019to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Belarus1 site, 1 recruiting
- Recruiting
Educational Institution "Belarusian State Medical University"
Minsk, Dzerzhinski Ave., 83,, 220116
Varvara Boika, + 375 17 277-16-72, intdept@bsmu.by
About this study
Official title: 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).
Read the 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.
- Conditions
- Varicose Veins, Surgery
- Being tested
- Micronized Purified Flavonoid Fraction
- Keywords
- VV, MPPF, MOCA, QoL
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micronized Purified Flavonoid FractionDrug
Also called Endovenous Mechano-Chemical Ablation
Based on the (non-)use of adjuvant phlebotropic therapy in the postoperative period.
| Study group | Role | What they receive |
|---|---|---|
| Group A, MPFF-group | MPFF [Detralex®, Servier, France] 1,000 mg OD for 30 days in the postoperative period. Receives: Drug: Micronized Purified Flavonoid Fraction | |
| Group B | No venoactive drug prescribed in the postoperative period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 30 days
Secondary outcomes (1)
Responders to Treatment, Assessed by Duplex Ultrasound
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start1 Jan 2019
- Primary completion18 Jun 2021
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Belarusian State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vladimir Khryshchanovich, Belarusian State Medical University
- Investigators
- Vladimir Khryshchanovich, MD, Prof, Study chair, Educational Institution "Belarusian State Medical University"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434274
- Sponsor's protocol ID
- 20140455
- Acronym
- MIFFMOCA
- Status last verified
- Nov 2021
- First submitted
- 10 Jun 2020
- Last updated
- 16 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Publications
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.
PubMed 31970659Pokrovsky 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.
PubMed 18004259Bogachev 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.
PubMed 22929677Bogachev 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.
PubMed 28945060Mansilha 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.
PubMed 31284708Sun 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.
PubMed 28811080
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of MIcronized Purified Flavonoid Fraction-Based Phlebotropic Therapy After Endovenous MechanO-Chemical Ablation
- ClinicalTrials.gov ID
- NCT04434274
- Acronym / sponsor ID
- MIFFMOCA / 20140455
- Conditions
- Varicose Veins, Surgery
- Keywords
- VV, MPPF, MOCA, QoL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Belarusian State Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 18 Jun 2021 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A, MPFF-group | – | Drug: Micronized Purified Flavonoid FractionMPFF [Detralex®, Servier, France] 1,000 mg OD for 30 days in the postoperative period. |
| Group B | – | –No venoactive drug prescribed in the postoperative period. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micronized Purified Flavonoid FractionAlso: Endovenous Mechano-Chemical AblationBased on the (non-)use of adjuvant phlebotropic therapy in the postoperative period. | Drug | Group A, MPFF-group |
Primary outcome
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
1 secondary outcome
Responders to Treatment, Assessed by Duplex Ultrasound
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- Background: PubMed 31970659Nicolaides 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.
- Background: PubMed 18004259Pokrovsky 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.
- Background: PubMed 22929677Bogachev 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.
- Background: PubMed 28945060Bogachev 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.
- Background: PubMed 31284708Mansilha 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.
- Background: PubMed 28811080Sun 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.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir Khryshchanovich, MD, Prof study chair
Educational Institution "Belarusian State Medical University"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Varicose Veins and Surgery, run by Belarusian State Medical University at 1 site in Belarus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vladimir Khryshchanovich, MD, Prof (+375296245578, vladimirkh77@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with pain from absent (score 0) to severe (score 3) (time frame: 7 days). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04434274, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.