MechanO-Chemical Ablation Versus CompreSSion

Surgery Clinical Trial

— MOCASS  

Official title:

Endovenous MechanO-Chemical Ablation Plus Compression Versus CompreSSion Alone in Chronic Venous Ulcers Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04441957
• Other study ID #: 20140456
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2021
• Source: Belarusian State Medical University
• Contact: Vladimir MD Khryshchanovich, Prof
• Phone: +375296245578
• Email: vladimirkh77[@]mail.ru
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2021
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patient age > 18 years.

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:

1. Postoperative varicose veins disease recurrence.

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.

Related Conditions & MeSH terms

• Surgery
• Varicose Veins

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Belarus	Educational Institution "Belarusian State Medical University"	Minsk	Dzerzhinski Ave., 83,

Sponsors (2)

Lead Sponsor	Collaborator
Belarusian State Medical University	Medical University of Warsaw

Country where clinical trial is conducted

Belarus, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	6-12 months
Primary	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)	6-12 months
Primary	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)	6-12 months
Primary	Number of Participants with active ulcers from absent (score 0) to severe (score 3).	None (0), 1 (1), 2 (2), more than 2 (3)	6-12 months
Primary	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)	6-12 months
Secondary	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)	3-24 months