Compression Stockings Therapy Following Mechano-Chemical Ablation (Clarivein®) (COMMOCA)

October 29, 2020 updated by: Singapore General Hospital

A Randomised Controlled Trial of Compression Stockings Therapy Following Mechano-Chemical Ablation

This study will be looking at the effect of compression therapy in patients having Mechano-Chemical Ablation (MOCA) therapy for truncal incompetence of their varicose veins using the ClariVein® device. Patients will be randomised to either the compression group (group A) or the no compression group (group B).

The pain scores, compliance, quality of life scores, occlusion rate at 6 months as well as the cost effectiveness of each intervention will be assessed.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Varicose veins are common and are known to affect approximately one third of the population. Chronic Venous Disease (CVD) has been shown to have a negative impact on the quality of life of patients and treatment of varicose veins has been demonstrated to lead to improvement in the quality of life of patients. Over the past decade, new endovenous techniques have been introduced and these are felt to be cost-effective, especially, when performed in an outpatient or 'office-based' setting.

There is currently uncertainty about the use of compression stockings following treatment of varicose veins. International Union of Phlebology (IUP), The Society for Vascular Surgery and the American Venous Forum, as well as 2013 National Institute for Health and Care Excellence (NICE) Guideline on Varicose Veins in the Legs have recommended that compression stockings are suitable in certain clinical indications and can be worn post-operatively for no more than 7 days after interventional treatment to prevent haematoma formation, pain and swelling. However, further research is essential for determining clinical and cost effectiveness, as well as length of time compression should be worn, and level of compression.

Several researchers have looked into the practice of using compression after venous ablation. In a survey of the management of varicose veins by the members of the Vascular Society of Great Britain and Ireland. Edwards et al. found that the majority of surgeons used bandages post-operatively, with 49% using elastic bandage. To date, the literature on the use of compression stockings following treatment of varicose veins is limited.

Mechano-Chemical Ablation (MOCA) combines mechanical damage to the endothelium caused by a rotating wire with simultaneous catheter-guided infusion of a liquid sclerosant that irreversibly damages the cellular membrane of the endothelium, causing fibrosis of the vein. The exact mechanism is still not exactly known. However, recent experimental research showed that various sclerosants induced apoptosis in the vein wall rather than having an effect restricted to the endothelium. Incomplete loss of endothelial cells and penetration of the sclerosant effect into the media suggest that medial damage is crucial to the success of sclerotherapy and may explain why it is less effective in larger veins. This poses the question whether compression is needed post sclerotherapy to improve contact of the sclerosant to the endothelium when media penetration seems to be more important to allow apoptosis of smooth muscle cells.

The investigators therefore propose to undertake a randomised study looking at the effect of compression therapy after MOCA using Clarivein device

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Ireland
    • Galway
      • Galway City, Galway, Ireland
        • Recruiting
        • Galway University Hospital
        • Contact:
          • Prof Stewart Walsh
  • Singapore
      • Singapore, Singapore
        • Recruiting
        • Singapore General Hospital

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

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age>=21 to <=80
  • Able to walk unassisted and attend follow-up visits
  • Symptomatic Great Saphenous Vein (GSV) or Small Saphenous Vein (SSV) vein reflux >0.5 seconds on colour Duplex ultrasound
  • Able to provide informed consent

Exclusion Criteria:

  • Previous or current deep vein thrombosis or pulmonary embolism
  • Patients with a hypercoaguable state
  • Previous thrombophlebitis in the truncal vein in question, which had recanalized and was now incompetent on duplex ultrasound
  • Recurrent varicose vein i.e. patients who have had treatment previously in the designated truncal vein with any modality
  • Patients who have had treatment in either leg for an incompetent saphenous truncal vein less than 3 months prior to treatment and enrolment into this study
  • Patients requiring adjuvant treatment of varicose veins
  • Arterial disease (ABPI < 0.6 and the absence of a palpable pedal pulse)
  • Vein diameter <3mm or >12mm as measured in the standing position on duplex ultrasound
  • Varicose veins unsuitable for MOCA (e.g. very tortuous vein)
  • Pregnancy
  • Lycra, sclerosant or local anaesthetic allergy
  • Patients who have opted for an alternative method of treatment
  • Patients with fibromyalgia
  • Patients with Clinical, Etiologic, Anatomic and Pathophysiologic (CEAP) score of C6 (active ulcer), C1 and C2 (asymptomatic) disease
  • Patients with a life expectancy less than 12 months
  • Inability or unwillingness to complete questionnaires
  • Patients who refuses to participate and unable to provide informed consent or comply with the study protocol.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Compression
Patient will receive Class II above knee compression stockings, and will be asked to wear it for 1 week. This would involve wearing the stocking during daytime but patients will be allowed to take it off at night whilst in bed.
Other: Compression Stockings
Class II above knee compression stockings
No Intervention: No Compression
Patient will not receive any compression stockings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score post-procedure
Time Frame: First 10 days post-procedure
Participants will record their pain score using the Visual Analogue Score (VAS) for pain. The scale ranges from 0 (no pain) to 10 (worst pain imaginable).
First 10 days post-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life score using the EQ-5D questionnaire
Time Frame: Baseline, 2 weeks post-op, 6 months post-op
EQ-5D is used to assess quality of life based on Mobility, Self-care, Usual Activities, Pain/Discomfort and Anxiety, rated at 5 levels: no problems, slight problems, moderate problems, severe problems, unable to perform activity. Inputs from this questionnaire is used to observe for changes in quality of life overtime
Baseline, 2 weeks post-op, 6 months post-op
Quality of life score using the Chronic Venous Insufficiency Questionnaire (CIVIQ)
Time Frame: Baseline, 2 weeks post-op, 6 months post-op
CIVIQ-14 is a questionnaire based on three dimensions - pain, physical and psychological, based on a scale from 1 to 5 (no trouble, slight, moderate, considerable, severe). Based on inputs, Global Index Score (GIS) will be tabulated, ranging from 0 to 100 - the higher the value, the poorer the quality of life.
Baseline, 2 weeks post-op, 6 months post-op
Quality of life score using the Aberdeen Varicose Veins Questionnaire (AVVQ)
Time Frame: Baseline, 2 weeks post-op, 6 months post-op
To measure health status of varicose vein patients based on symptoms and impact on daily activities. A total score ranging from 0 to 100 will be tabulated, with 100 being worst quality of life
Baseline, 2 weeks post-op, 6 months post-op
Clinical Change using Venous Clinical Severity Score (VCSS)
Time Frame: Baseline, 2 weeks post-op, 6 months post-op
VCSS evaluates the severity of hallmarks of venous disease - 0 (none), 1 (Mild) , 2(Moderate), 3 (Severe).
Baseline, 2 weeks post-op, 6 months post-op
Time taken to return to work and normal activities
Time Frame: 10 days post-op
10 days post-op
Degree of bruising and phlebitis
Time Frame: 2 weeks post-op, 6 months post-op
Assessed using a pre-determined score (0=0%; 1= <25% of treated vein affected; 2 = 25-50% ; 3 = 50-75%; 4 = 75-100% and 5 = extending beyond the treated vein
2 weeks post-op, 6 months post-op
The number of patient compliant with the intervention
Time Frame: 10 days post-op
10 days post-op
Patient's satisfaction
Time Frame: 2 weeks post-op, 6 months post-op
To rate satisfaction with overall teatment regime with a numerical scale of 0 (least satisfied) to 10 (most satisfied)
2 weeks post-op, 6 months post-op
Comparison of the cost-effectiveness of the intervention
Time Frame: 6 months post-op
Analyze cost and patient outcomes to determine effectiveness of interventions
6 months post-op
Successful obliteration of target vein
Time Frame: 2 weeks post-op, 6 months post-op
This is assessed by duplex ultrasound scan. Recanalization will be defined by a segment of vein greater than or equal to 5cm
2 weeks post-op, 6 months post-op

Collaborators and Investigators

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

Sponsor

Singapore General Hospital

Collaborators

National University of Ireland, Galway, Ireland

Investigators

  • Principal Investigator: Tang Tjun Yip, Singapore General Hospital

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)

February 13, 2019

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

September 21, 2018

First Submitted That Met QC Criteria

September 24, 2018

First Posted (Actual)

September 26, 2018

Study Record Updates

Last Update Posted (Actual)

October 30, 2020

Last Update Submitted That Met QC Criteria

October 29, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COMMOCA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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