MechanO-Chemical Ablation Versus CompreSSion (MOCASS)

November 13, 2021 updated by: Vladimir Khryshchanovich, Belarusian State Medical University

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belarus
    • Dzerzhinski Ave., 83,
      • Minsk, Dzerzhinski Ave., 83,, Belarus, 220116
        • Recruiting
        • Educational Institution "Belarusian State Medical University"
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with GSV incompetence and C6 were included in in the prospective consecutive case study if they satisfied the selection criteria.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6-12 months
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)
6-12 months
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)
6-12 months
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)
6-12 months
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)
6-12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3-24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Belarusian State Medical University

Collaborators

Medical University of Warsaw

Investigators

  • Study Chair: Vladimir MD Khryshchanovich, Prof, Educational Institution "Belarusian State Medical University"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

June 15, 2020

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

June 19, 2020

First Submitted That Met QC Criteria

June 19, 2020

First Posted (Actual)

June 22, 2020

Study Record Updates

Last Update Posted (Actual)

November 16, 2021

Last Update Submitted That Met QC Criteria

November 13, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20140456

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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).

IPD Sharing Time Frame

12.2021

IPD Sharing 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).

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Surgery

Clinical Trials on Endovenous Mechano- Chemical Ablation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe