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

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ClinicalTrials.gov Identifier: NCT03685838
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : April 4, 2019
Sponsor:
Collaborator:
National University of Ireland, Galway, Ireland
Information provided by (Responsible Party):
Singapore General Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Varicose Veins Chronic Venous Insufficiency Other: Compression Stockings Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of Compression Stockings Therapy Following Mechano-Chemical Ablation
Actual Study Start Date : February 13, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

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.



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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).

  5. Time taken to return to work and normal activities [ Time Frame: 10 days post-op ]
  6. 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

  7. The number of patient compliant with the intervention [ Time Frame: 10 days post-op ]
  8. 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)

  9. Comparison of the cost-effectiveness of the intervention [ Time Frame: 6 months post-op ]
    Analyze cost and patient outcomes to determine effectiveness of interventions

  10. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03685838


Contacts
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Contact: Tang Tjun Yip 65767986 tang.tjun.yip@singhealth.com.sg
Contact: Charyl Yap charyl.yap.j.q@sgh.com.sg

Locations
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Ireland
Galway University Hospital Recruiting
Galway City, Galway, Ireland
Contact: Prof Stewart Walsh         
Singapore
Singapore General Hospital Recruiting
Singapore, Singapore
Sponsors and Collaborators
Singapore General Hospital
National University of Ireland, Galway, Ireland
Investigators
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Principal Investigator: Tang Tjun Yip Singapore General Hospital
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT03685838    
Other Study ID Numbers: COMMOCA
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Singapore General Hospital:
mechano-chemical ablation
compression stockings
Additional relevant MeSH terms:
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Venous Insufficiency
Varicose Veins
Vascular Diseases
Cardiovascular Diseases