Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2018-01-01
2021-12-31
Brief Summary
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Detailed Description
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To get the ulcer to heal, the current best treatment is to wear a compression bandage with multiple layers, with which about 60% of these ulcers will heal within 6 months.
There is evidence that treatment of the varicose veins by sahenous veins stripping will prevent the ulcer recurrence.
Recent studies have suggested that novel proceduress of superficial truncal reflux elimination, such as foam sclerotherapy or treating the saphenous veins with termal (laser or radiofrequency) ablation to seal it effectively, may help the ulcers to heal more quickly and increase recurrence-free rate. These techniques can be carried out in the outpatient setting and are much better tolerated by patients in comparison to surgery.
At the same time, no studies which compared compression plus endovenous mechanochemical ablation (MOCA) vs. compression alone in chronic venous ulcers have been conducted to date.
The aim of this study is to see whether treatment of varicose veins using MOCA helps with healing.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group A, MOCA-group
Procedure/Surgery: MOCA Mechano-Chemical Ablation plus Elastic Compression
Endovenous Mechano- Chemical Ablation
The Flebogrif™ catheter (Balton® Sp. z o.o., Warsaw, Poland) represents endoluminal Non Thermal Non Tumescent devices designed to cause occlusion (fibrosis) of the target vein through the combined mechanical and chemical damage to its endothelial lining with retractable cutters and foamed sclerosant.
Group B, Elastic Compression only group
Treatment: Elastic Compression only
No interventions assigned to this group
Interventions
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Endovenous Mechano- Chemical Ablation
The Flebogrif™ catheter (Balton® Sp. z o.o., Warsaw, Poland) represents endoluminal Non Thermal Non Tumescent devices designed to cause occlusion (fibrosis) of the target vein through the combined mechanical and chemical damage to its endothelial lining with retractable cutters and foamed sclerosant.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Current leg ulceration of greater than 6 weeks.
3. Great saphenous vein (GSV) incompetence with reflux at least down to the knee level.
4. Primary symptomatic varicose veins, Clinical Etiological Anatomical Pathophysiological (CEAP) classification, clinical class C6.
5. Able to give informed consent to participate in the study after reading the patient information documentation.
6. Ankle Brachial Pressure Index (ABPI) ≥ 0.8.
Exclusion Criteria
2. Patients who are unable to tolerate any multilayer compression bandaging / stockings will be excluded.
3. Deep venous thrombosis, thrombophilia associated with a high risk of deep venous thrombosis or postthrombotic syndrome.
4. History of pulmonary embolism or stroke.
5. Current anticoagulation therapy (within 7 days of enrollment).
6. Pregnant or lactating women.
18 Years
80 Years
ALL
No
Sponsors
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Medical University of Warsaw
OTHER
Belarusian State Medical University
OTHER
Responsible Party
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Vladimir Khryshchanovich
Professor
Principal Investigators
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Vladimir MD Khryshchanovich, Prof
Role: STUDY_CHAIR
Educational Institution "Belarusian State Medical University"
Locations
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Educational Institution "Belarusian State Medical University"
Minsk, Dzerzhinski Ave., 83,, Belarus
Countries
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Central Contacts
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Facility Contacts
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Varvara Boika
Role: primary
References
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Kanchanabat B, Stapanavatr W, Kanchanasuttiruk P. Total superficial vein reflux eradication in the treatment of venous ulcer. World J Surg. 2015 May;39(5):1301-5. doi: 10.1007/s00268-014-2935-y.
Barwell JR, Davies CE, Deacon J, Harvey K, Minor J, Sassano A, Taylor M, Usher J, Wakely C, Earnshaw JJ, Heather BP, Mitchell DC, Whyman MR, Poskitt KR. Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): randomised controlled trial. Lancet. 2004 Jun 5;363(9424):1854-9. doi: 10.1016/S0140-6736(04)16353-8.
Gohel MS, Heatley F, Liu X, Bradbury A, Bulbulia R, Cullum N, Epstein DM, Nyamekye I, Poskitt KR, Renton S, Warwick J, Davies AH; EVRA Trial Investigators. A Randomized Trial of Early Endovenous Ablation in Venous Ulceration. N Engl J Med. 2018 May 31;378(22):2105-2114. doi: 10.1056/NEJMoa1801214. Epub 2018 Apr 24.
Sullivan LP, Quach G, Chapman T. Retrograde mechanico-chemical endovenous ablation of infrageniculate great saphenous vein for persistent venous stasis ulcers. Phlebology. 2014 Dec;29(10):654-7. doi: 10.1177/0268355513501301. Epub 2013 Aug 22.
Elias S, Raines JK. Mechanochemical tumescentless endovenous ablation: final results of the initial clinical trial. Phlebology. 2012 Mar;27(2):67-72. doi: 10.1258/phleb.2011.010100. Epub 2011 Jul 29.
Other Identifiers
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20140456
Identifier Type: -
Identifier Source: org_study_id