MechanO-Chemical Ablation Versus CompreSSion

Overview

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).

Full Title of Study: “Endovenous MechanO-Chemical Ablation Plus Compression Versus CompreSSion Alone in Chronic Venous Ulcers Treatment”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 15, 2020

Detailed 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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Group A, MOCA-group
    • Procedure/Surgery: MOCA Mechano-Chemical Ablation plus Elastic Compression
  • Group B, Elastic Compression only group
    • Treatment: Elastic Compression only

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants with varicose Veins from absent (score 0) to severe (score 3).
    • Time Frame: 6-12 months
    • None (0), Few, scattered (1), Confined to calf or thigh (2) Involve calf and thigh (3)
  • Number of Participants with skin Pigmentation from absent (score 0) to severe (score 3).
    • Time Frame: 6-12 months
    • None (0), Limited to perimalleolar area (1), Diffuse over lower third of calf (2), Wider distribution (above lower third of calf) (3)
  • Number of Participants with induration from absent (score 0) to severe (score 3).
    • Time Frame: 6-12 months
    • None (0), Limited to perimalleolar area (1), Involving lower third of calf (2), Involving more than lower third of calf (3)
  • Number of Participants with active ulcers from absent (score 0) to severe (score 3).
    • Time Frame: 6-12 months
    • None (0), 1 (1), 2 (2), more than 2 (3)
  • Number of Participants with active ulcer diameter from absent (score 0) to severe (score 3).
    • Time Frame: 6-12 months
    • None (0), Diameter less than 2 cm (1), Diameter 2-6 cm (2), Diameter more than 6 cm (3)

Secondary Measures

  • Number of Participants with ulcer recurrence-free rate (no – score 0, yes – score 1)
    • Time Frame: 3-24 months
    • None (0), Less than 3 months (1), More than 3 months but less than 1 year (2) More than 1year (3)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Belarusian State Medical University
  • Collaborator
    • Medical University of Warsaw
  • Provider of Information About this Clinical Study
    • Principal Investigator: Vladimir Khryshchanovich, Professor – Belarusian State Medical University
  • Overall Official(s)
    • Vladimir MD Khryshchanovich, Prof, Study Chair, Educational Institution “Belarusian State Medical University”
  • Overall Contact(s)
    • Vladimir MD Khryshchanovich, Prof, +375296245578, vladimirkh77@mail.ru

References

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.

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.

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