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    Clinical Trial Results:
    Randomised controlled trial comparing foam sclerotherapy, alone or in combination with endovenous laser therapy, with conventional surgery as a treatment for varicose veins

    Summary
    EudraCT number
    		 2008-001069-26
    Trial protocol
    		 GB  
    Global end of trial date
    29 Nov 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Feb 2019
    First version publication date
    13 Feb 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    06/45/02
    Additional study identifiers
    ISRCTN number
    		 ISRCTN51995477
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Aberdeen
    Sponsor organisation address
    Foresterhill House Annex, Foresterhill, Aberdeen, United Kingdom, AB25 2ZD
    Public contact
    Julie Brittenden, University of Glasgow, 0141 2321795, Julie.Brittenden@glasgow.ac.uk
    Scientific contact
    Julie Brittenden, University of Glasgow, 0141 2321795, Julie.Brittenden@glasgow.ac.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Nov 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Nov 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Nov 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the clinical and cost-effectiveness of conventional surgery with two minimally invasive treatment modalities (a) foam sclerotherapy alone of main long or short saphenous trunk and non-trunk varicosities and (b) Endovenous laser ablation (EVLA) of main trunk including foam sclerotherapy of non-trunk varicosities, if required, performed under local anaesthetic in respect of quality of life for each intervention at 6 months (and ultimately through to 5 years) and cost-effectiveness as cost per quality adjusted life year (QALY) gained
    Protection of trial subjects
    All trial subjects provided fully informed consent. Trial oversight by Sponsor, independent data monitoring and trial steering committees.
    Background therapy
    		 Participants may have been on background therapy - this was not changed in the context of the trial
    Evidence for comparator
    		 Surgery has been used in the treatment of varicose veins for many years. Ultrasound-guided foam sclerotherapy and endovenous laser ablation are widely used alternatives to surgery for the treatment of varicose veins, but their comparative effectiveness and safety remain uncertain.
    Actual start date of recruitment
    03 Nov 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 785
    Worldwide total number of subjects
    785
    EEA total number of subjects
    785
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    672
    From 65 to 84 years
    112
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Potentially eligible patients were provided with information about the trial; those providing fully informed consent were randomised. 8 hospitals randomised participants to all three treatment options; 3 hospitals randomised to surgery and foam sclerotherapy only.

    Pre-assignment
    Screening details
    		 Patients referred to one of 11 UK vascular surgery departments were screened for eligibility.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    None

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Foam Sclerotherapy
    Arm description
    		 Up to four treatments with foam sclerotherapy injected into the varicose vein(s)
    Arm type
    		 Experimental

    Investigational medicinal product name
    fibrovein
    Investigational medicinal product code
    C05BB04
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Other use
    Dosage and administration details
    Foam was produced with the use of the Tessari technique at a ratio of 0.5ml of sodium tetradecyl sulphate to 1.5ml air, with a maximum of 12 ml of foam per session. 3% sodium tetradecyl sulphate was used for saphenous veins, 1% sodium tetradecyl sulphate was used for varicosities.

    Arm title
    		 Surgery
    Arm description
    		 Conventional surgery for varicose veins
    Arm type
    		 surgical active comparator

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Laser therapy
    Arm description
    		 Endovenous laser ablation, with up to four sessions of foam sclerotherapy to residual varicose veins.
    Arm type
    		 Surgical active comparator

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Foam Sclerotherapy Surgery Laser therapy
    Started
    286
    289
    210
    Completed
    251
    236
    183
    Not completed
    35
    53
    27
         Lost to follow-up
    35
    53
    27

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Foam Sclerotherapy
    Reporting group description
    		 Up to four treatments with foam sclerotherapy injected into the varicose vein(s)

    Reporting group title
    Surgery
    Reporting group description
    		 Conventional surgery for varicose veins

    Reporting group title
    Laser therapy
    Reporting group description
    		 Endovenous laser ablation, with up to four sessions of foam sclerotherapy to residual varicose veins.

    Reporting group values
    		 Foam Sclerotherapy Surgery Laser therapy Total
    Number of subjects
    		 286 289 210 785
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 250 253 169 672
        From 65-84 years
    		 36 35 41 112
        85 years and over
    		 0 1 0 1
    Age continuous
    Age (years)
    Units: years
        arithmetic mean (standard deviation)
    		 49.0 ( 13.3 ) 49.2 ( 13.7 ) 49.7 ( 14.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 162 163 120 445
        Male
    		 124 126 90 340

    End points

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    End points reporting groups
    Reporting group title
    Foam Sclerotherapy
    Reporting group description
    		 Up to four treatments with foam sclerotherapy injected into the varicose vein(s)

    Reporting group title
    Surgery
    Reporting group description
    		 Conventional surgery for varicose veins

    Reporting group title
    Laser therapy
    Reporting group description
    		 Endovenous laser ablation, with up to four sessions of foam sclerotherapy to residual varicose veins.

    Subject analysis set title
    6 month intention to treat
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants attending for 6 month follow-up

    Primary: Aberdeen Varicose Vein Questionnaire

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    End point title
    		 Aberdeen Varicose Vein Questionnaire
    End point description
    End point type
    Primary
    End point timeframe
    6 months
    End point values
    		 Foam Sclerotherapy Surgery Laser therapy
    Number of subjects analysed
    238
    214
    175
    Units: points
        arithmetic mean (standard deviation)
    9.1 ( 7.9 )
    7.8 ( 7.5 )
    7.9 ( 8.4 )
    Statistical analysis title
    		 surgery vs foam
    Comparison groups
    Surgery v Foam Sclerotherapy
    Number of subjects included in analysis
    452
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3
         upper limit
    		 -0.5
    Variability estimate
    Standard error of the mean
    Statistical analysis title
    		 surgery vs laser
    Comparison groups
    Surgery v Laser therapy
    Number of subjects included in analysis
    389
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.2
         upper limit
    		 0.9
    Variability estimate
    Standard error of the mean
    Statistical analysis title
    		 laser vs foam
    Comparison groups
    Laser therapy v Foam Sclerotherapy
    Number of subjects included in analysis
    413
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.6
         upper limit
    		 0.4
    Variability estimate
    Standard error of the mean

    Primary: EQ-5D

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    End point title
    		 EQ-5D
    End point description
    End point type
    Primary
    End point timeframe
    6 months
    End point values
    		 Foam Sclerotherapy Surgery Laser therapy
    Number of subjects analysed
    238
    214
    175
    Units: points
        arithmetic mean (standard deviation)
    0.895 ( 0.174 )
    0.881 ( 0.202 )
    0.903 ( 0.171 )
    Statistical analysis title
    		 surgery vs foam
    Comparison groups
    Foam Sclerotherapy v Surgery
    Number of subjects included in analysis
    452
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.005
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.025
         upper limit
    		 0.035
    Variability estimate
    Standard error of the mean
    Statistical analysis title
    		 surgery vs laser
    Comparison groups
    Surgery v Laser therapy
    Number of subjects included in analysis
    389
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.015
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.051
         upper limit
    		 0.021
    Variability estimate
    Standard error of the mean
    Statistical analysis title
    		 laser vs foam
    Comparison groups
    Laser therapy v Foam Sclerotherapy
    Number of subjects included in analysis
    413
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.025
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.01
         upper limit
    		 0.059
    Variability estimate
    Standard error of the mean

    Primary: SF-36 Physical component

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    End point title
    		 SF-36 Physical component
    End point description
    End point type
    Primary
    End point timeframe
    6 months
    End point values
    		 Foam Sclerotherapy Surgery Laser therapy
    Number of subjects analysed
    238
    214
    175
    Units: points
        arithmetic mean (standard deviation)
    52.3 ( 8.5 )
    52.4 ( 8.9 )
    52.6 ( 7.3 )
    Statistical analysis title
    		 surgery vs foam
    Comparison groups
    Surgery v Foam Sclerotherapy
    Number of subjects included in analysis
    452
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 2.3
    Variability estimate
    Standard error of the mean
    Statistical analysis title
    		 surgery vs laser
    Comparison groups
    Surgery v Laser therapy
    Number of subjects included in analysis
    389
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 1.6
    Variability estimate
    Standard error of the mean
    Statistical analysis title
    		 laser vs foam
    Comparison groups
    Laser therapy v Foam Sclerotherapy
    Number of subjects included in analysis
    413
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 2.1
    Variability estimate
    Standard error of the mean

    Primary: SF-36 Mental component

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    End point title
    		 SF-36 Mental component
    End point description
    End point type
    Primary
    End point timeframe
    6 months
    End point values
    		 Foam Sclerotherapy Surgery Laser therapy
    Number of subjects analysed
    238
    214
    175
    Units: points
        arithmetic mean (standard deviation)
    52.2 ( 9.1 )
    52.1 ( 8.6 )
    53.5 ( 7.7 )
    Statistical analysis title
    		 surgery vs foam
    Comparison groups
    Surgery v Foam Sclerotherapy
    Number of subjects included in analysis
    452
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 1.6
    Variability estimate
    Standard error of the mean
    Statistical analysis title
    		 surgery vs laser
    Comparison groups
    Surgery v Laser therapy
    Number of subjects included in analysis
    389
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.9
         upper limit
    		 0.2
    Variability estimate
    Standard error of the mean
    Statistical analysis title
    		 laser vs foam
    Comparison groups
    Laser therapy v Foam Sclerotherapy
    Number of subjects included in analysis
    413
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 3.1
    Variability estimate
    Standard error of the mean

    Secondary: Success of ablation of the great saphenous vein

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    End point title
    		 Success of ablation of the great saphenous vein
    End point description
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 Foam Sclerotherapy Surgery Laser therapy
    Number of subjects analysed
    182
    173
    141
    Units: subjects
        Complete success
    79
    135
    116
        Partial success without reflux
    35
    4
    13
        Partial success with reflux
    9
    20
    3
        Failure
    59
    14
    9
    Statistical analysis title
    		 surgery vs foam
    Comparison groups
    Surgery v Foam Sclerotherapy
    Number of subjects included in analysis
    355
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    4.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.1
         upper limit
    		 7.9
    Variability estimate
    Standard error of the mean
    Statistical analysis title
    		 surgery vs laser
    Comparison groups
    Surgery v Laser therapy
    Number of subjects included in analysis
    314
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 1.5
    Variability estimate
    Standard error of the mean
    Statistical analysis title
    		 laser vs foam
    Comparison groups
    Laser therapy v Foam Sclerotherapy
    Number of subjects included in analysis
    323
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    4.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.8
         upper limit
    		 8.5
    Variability estimate
    Standard error of the mean

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    6 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Foam Sclerotherapy
    Reporting group description
    		 Up to four treatments with foam sclerotherapy injected into the varicose vein(s)

    Reporting group title
    Surgery
    Reporting group description
    		 Conventional surgery for varicose veins

    Reporting group title
    Laser therapy
    Reporting group description
    		 Endovenous laser ablation, with up to four sessions of foam sclerotherapy to residual varicose veins.

    Serious adverse events
    		 Foam Sclerotherapy Surgery Laser therapy
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 286 (3.85%)
    10 / 289 (3.46%)
    7 / 210 (3.33%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    myeloma
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 289 (0.00%)
    0 / 210 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    breast cancer
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 289 (0.00%)
    0 / 210 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 286 (0.00%)
    0 / 289 (0.00%)
    1 / 210 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    postoperative haematoma
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 289 (0.35%)
    0 / 210 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peroneal nerve injury
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 289 (0.35%)
    0 / 210 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 286 (0.00%)
    0 / 289 (0.00%)
    1 / 210 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Site specific injuries NEC
         subjects affected / exposed
    0 / 286 (0.00%)
    0 / 289 (0.00%)
    1 / 210 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 286 (0.35%)
    1 / 289 (0.35%)
    0 / 210 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    3 / 286 (1.05%)
    0 / 289 (0.00%)
    0 / 210 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    palpitation
         subjects affected / exposed
    0 / 286 (0.00%)
    0 / 289 (0.00%)
    1 / 210 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Surgery
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 289 (0.35%)
    0 / 210 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Involuntary commitment
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 289 (0.35%)
    0 / 210 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    migraine
         subjects affected / exposed
    0 / 286 (0.00%)
    0 / 289 (0.00%)
    1 / 210 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    transient ischaemic attack
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 289 (0.00%)
    0 / 210 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 289 (0.00%)
    0 / 210 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    stroke
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 289 (0.00%)
    0 / 210 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    ANAL POLYP
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 289 (0.35%)
    0 / 210 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    BREAST ENLARGEMENT
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 289 (0.35%)
    0 / 210 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 286 (0.00%)
    1 / 289 (0.35%)
    0 / 210 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    urinary retention
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 289 (0.00%)
    0 / 210 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal pain
         subjects affected / exposed
    1 / 286 (0.35%)
    0 / 289 (0.00%)
    2 / 210 (0.95%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Post procedural infection
         subjects affected / exposed
    0 / 286 (0.00%)
    2 / 289 (0.69%)
    0 / 210 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.05%
    Non-serious adverse events
    		 Foam Sclerotherapy Surgery Laser therapy
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    144 / 286 (50.35%)
    109 / 289 (37.72%)
    89 / 210 (42.38%)
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    38 / 286 (13.29%)
    40 / 289 (13.84%)
    25 / 210 (11.90%)
         occurrences all number
    38
    40
    25
    Lumpiness
         subjects affected / exposed
    67 / 286 (23.43%)
    17 / 289 (5.88%)
    25 / 210 (11.90%)
         occurrences all number
    67
    17
    25
    Vascular disorders
    development of thread veins
         subjects affected / exposed
    34 / 286 (11.89%)
    26 / 289 (9.00%)
    24 / 210 (11.43%)
         occurrences all number
    34
    26
    24
    Nervous system disorders
    NUMBNESS
         subjects affected / exposed
    10 / 286 (3.50%)
    37 / 289 (12.80%)
    17 / 210 (8.10%)
         occurrences all number
    10
    37
    17
    Skin and subcutaneous tissue disorders
    Skin loss or ulceration
         subjects affected / exposed
    2 / 286 (0.70%)
    0 / 289 (0.00%)
    1 / 210 (0.48%)
         occurrences all number
    2
    0
    1
    Skin staining
         subjects affected / exposed
    92 / 286 (32.17%)
    24 / 289 (8.30%)
    32 / 210 (15.24%)
         occurrences all number
    82
    24
    32

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Sep 2008
    Section 4.2 – deleted ‘and are suitable for day case treatment’ from the inclusion criteria. Section 4.8.3 – added expected serious adverse events related to laser and surgery and additional expected serious adverse events related to foam.
    06 Feb 2009
    Section 4.1 – revision of detail re fibrovein administration and addition of info re labelling and storage; removal of specific type of laser. Section 4.2 – clarification re HRT. Section 4.3 – addition of detail re clinic log, postal information leaflet, consent by post. Section 4.4 – clarification of randomisation and post-randomisation processes. Section 4.7 – addition of VAS to assess pain during treatment; timing of BRQ.
    17 Jun 2009
    Section 4 – revision to add additional (unnamed) sites. Section 7.3 – removal of sentence relating to joint sponsorship.
    23 Oct 2009
    Section 4.8.3 - inclusion of TIA as an expected adverse reaction following foam sclerotherapy.
    22 Feb 2010
    Section 4.8.1 – revision of definition of SAE: inclusion of category ‘an important medical event that may not be immediately life threatening or result in death, but may jeopardise the patient or may require intervention to prevent one of the other outcomes listed in the definition’.
    08 Oct 2010
    Section 4.1 – rewording of paragraph detailing the storage and temperature monitoring of Fibrovein. Section 6.4 – revised recruitment rates. Section 4 – rewording of paragraph on trial design.
    25 May 2011
    Section 4.1 – rewording of paragraph detailing Fibrovein labelling; removal of obligation to label FV
    08 Nov 2011
    Addition of migraines ‘which are frequent…or…severe enough to require hospitalisation’ as an exclusion criteria. Addition of migraine as an expected AE following foam sclerotherapy.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    There was no blinding. Comparison did not include radio-frequency ablation.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/25251616
    http://www.ncbi.nlm.nih.gov/pubmed/25858333
    http://www.ncbi.nlm.nih.gov/pubmed/25274220
    http://www.ncbi.nlm.nih.gov/pubmed/26805720
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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