An observational study in Varicose Veins and Surgery, sponsored by Belarusian State Medical University. Status unknown at 1 site in Belarus. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-11-16.
Sponsored by Belarusian State Medical University · Observational
This study will be looking at the effect of Endovenous Mechano-Chemical Ablation (MOCA) in addition to multilayer elastic compression bandaging vs multilayer elastic compression bandaging only in patients with incompetent great saphenous vein (GSV) and venous ulcers (VU's).
The most severe form of chronic venous disease is venous ulceration with an overall prevalence of about 1% in the adult population. Venous ulcers significantly impair quality of life, and their treatment places a heavy financial burden upon healthcare systems.
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.
369 studies on the registry are indexed under Varicose Ulcer; 77 are open to participants now.
This study's planned enrollment of 50 is below the median of 131 across 47 observational studies indexed under Varicose Ulcer.
Browse Varicose Ulcer studies →Belarusian State Medical University is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Compared within Varicose Ulcer, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Varicose Veins. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patients with GSV incompetence and C6 were included in in the prospective consecutive case study if they satisfied the selection criteria.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure/Surgery: MOCA Mechano-Chemical Ablation plus Elastic Compression
Device: Endovenous Mechano- Chemical Ablation
Treatment: Elastic Compression only
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.
Also known as: MOCA
Number of Participants with varicose Veins from absent (score 0) to severe (score 3).
None (0), Few, scattered (1), Confined to calf or thigh (2) Involve calf and thigh (3)
Time frame: 6-12 months
Number of Participants with skin Pigmentation from absent (score 0) to severe (score 3).
None (0), Limited to perimalleolar area (1), Diffuse over lower third of calf (2), Wider distribution (above lower third of calf) (3)
Time frame: 6-12 months
Number of Participants with induration from absent (score 0) to severe (score 3).
None (0), Limited to perimalleolar area (1), Involving lower third of calf (2), Involving more than lower third of calf (3)
Time frame: 6-12 months
Number of Participants with active ulcers from absent (score 0) to severe (score 3).
None (0), 1 (1), 2 (2), more than 2 (3)
Time frame: 6-12 months
Number of Participants with active ulcer diameter from absent (score 0) to severe (score 3).
None (0), Diameter less than 2 cm (1), Diameter 2-6 cm (2), Diameter more than 6 cm (3)
Time frame: 6-12 months
Number of Participants with ulcer recurrence-free rate (no - score 0, yes - score 1)
None (0), Less than 3 months (1), More than 3 months but less than 1 year (2) More than 1year (3)
Time frame: 3-24 months
Plan to share: Yes — To compare clinical efficacy of Endovenous Mechano-Chemical Ablation (MOCA) in addition to multilayer elastic compression bandaging and multilayer elastic compression bandaging only in patients with incompetent great saphenous vein (GSV) and venous ulcers (VU's).
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: 12.2021
Access criteria: To compare clinical efficacy of Endovenous Mechano-Chemical Ablation (MOCA) in addition to multilayer elastic compression bandaging and multilayer elastic compression bandaging only in patients with incompetent great saphenous vein (GSV) and venous ulcers (VU's).
Ran from Jan 2018 to primary completion in Jun 2020, 29 months.
Of 27 observational studies under Varicose Ulcer, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 141. This study's 29 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Belarusian State Medical University