Compression Stockings Therapy Following Mechano-Chemical Ablation (Clarivein®) (COMMOCA)
Primary Purpose
Varicose Veins, Chronic Venous Insufficiency
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Compression Stockings
Sponsored by
About this trial
This is an interventional treatment trial for Varicose Veins focused on measuring mechano-chemical ablation, compression stockings
Eligibility 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.
Sites / Locations
- Galway University HospitalRecruiting
- Singapore General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Compression
No Compression
Arm Description
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.
Patient will not receive any compression stockings.
Outcomes
Primary Outcome Measures
Pain Score 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
Quality of Life score using the EQ-5D questionnaire
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
Quality of life score using the Chronic Venous Insufficiency Questionnaire (CIVIQ)
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.
Quality of life score using the Aberdeen Varicose Veins Questionnaire (AVVQ)
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
Clinical Change using Venous Clinical Severity Score (VCSS)
VCSS evaluates the severity of hallmarks of venous disease - 0 (none), 1 (Mild) , 2(Moderate), 3 (Severe).
Time taken to return to work and normal activities
Degree of bruising and phlebitis
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
The number of patient compliant with the intervention
Patient's satisfaction
To rate satisfaction with overall teatment regime with a numerical scale of 0 (least satisfied) to 10 (most satisfied)
Comparison of the cost-effectiveness of the intervention
Analyze cost and patient outcomes to determine effectiveness of interventions
Successful obliteration of target vein
This is assessed by duplex ultrasound scan. Recanalization will be defined by a segment of vein greater than or equal to 5cm
Full Information
NCT ID
NCT03685838
First Posted
September 21, 2018
Last Updated
October 29, 2020
Sponsor
Singapore General Hospital
Collaborators
National University of Ireland, Galway, Ireland
1. Study Identification
Unique Protocol Identification Number
NCT03685838
Brief Title
Compression Stockings Therapy Following Mechano-Chemical Ablation (Clarivein®)
Acronym
COMMOCA
Official Title
A Randomised Controlled Trial of Compression Stockings Therapy Following Mechano-Chemical Ablation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 13, 2019 (Actual)
Primary Completion Date
October 1, 2021 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
Collaborators
National University of Ireland, Galway, Ireland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins, Chronic Venous Insufficiency
Keywords
mechano-chemical ablation, compression stockings
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Compression
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No Compression
Arm Type
No Intervention
Arm Description
Patient will not receive any compression stockings.
Intervention Type
Other
Intervention Name(s)
Compression Stockings
Intervention Description
Class II above knee compression stockings
Primary Outcome Measure Information:
Title
Pain Score post-procedure
Description
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).
Time Frame
First 10 days post-procedure
Secondary Outcome Measure Information:
Title
Quality of Life score using the EQ-5D questionnaire
Description
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
Time Frame
Baseline, 2 weeks post-op, 6 months post-op
Title
Quality of life score using the Chronic Venous Insufficiency Questionnaire (CIVIQ)
Description
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.
Time Frame
Baseline, 2 weeks post-op, 6 months post-op
Title
Quality of life score using the Aberdeen Varicose Veins Questionnaire (AVVQ)
Description
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
Time Frame
Baseline, 2 weeks post-op, 6 months post-op
Title
Clinical Change using Venous Clinical Severity Score (VCSS)
Description
VCSS evaluates the severity of hallmarks of venous disease - 0 (none), 1 (Mild) , 2(Moderate), 3 (Severe).
Time Frame
Baseline, 2 weeks post-op, 6 months post-op
Title
Time taken to return to work and normal activities
Time Frame
10 days post-op
Title
Degree of bruising and phlebitis
Description
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
Time Frame
2 weeks post-op, 6 months post-op
Title
The number of patient compliant with the intervention
Time Frame
10 days post-op
Title
Patient's satisfaction
Description
To rate satisfaction with overall teatment regime with a numerical scale of 0 (least satisfied) to 10 (most satisfied)
Time Frame
2 weeks post-op, 6 months post-op
Title
Comparison of the cost-effectiveness of the intervention
Description
Analyze cost and patient outcomes to determine effectiveness of interventions
Time Frame
6 months post-op
Title
Successful obliteration of target vein
Description
This is assessed by duplex ultrasound scan. Recanalization will be defined by a segment of vein greater than or equal to 5cm
Time Frame
2 weeks post-op, 6 months post-op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tang Tjun Yip
Phone
65767986
Email
tang.tjun.yip@singhealth.com.sg
First Name & Middle Initial & Last Name or Official Title & Degree
Charyl Yap
Email
charyl.yap.j.q@sgh.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tang Tjun Yip
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Galway University Hospital
City
Galway City
State/Province
Galway
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof Stewart Walsh
Facility Name
Singapore General Hospital
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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10396491
Citation
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Compression Stockings Therapy Following Mechano-Chemical Ablation (Clarivein®)
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