Varicose veins (VVs) or Superficial Venous Insufficiency (SVI) of the legs results from inflammation mediated damage to vein structure, allowing reverse flow. SVI affects 30% of adults and is associated with symptoms causing pain and disability
Conditions
Interventions
Trade Name: Fibrovein 3% Solution for Injection
Product Name: Fibrovein 3% Solution for Injection
Product Code: UK/H/2775/001-4/DC
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Sodi
Sponsors
Hull and East Yorkshire Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age 18 or over - Symptomatic SVI which will likely benefit from treatment in the opinion of an experienced specialist and the participant - Clinical grades C2-C6 on the CEAP system - Superficial axial incompetence with proposed treatment lengths of at least 10cm - Treatment with either endovenous laser ablation or mechanochemical ablation is technically feasible in the view of an experienced endovenous specialist - Patient is willing to participate (including acceptance of randomisation to either treatment) and give valid, informed consent in the English language Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 140 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 140
Exclusion criteria
Exclusion criteria: - One of the treatments is thought to be preferable by either the patient or an experienced endovenous specialist - Unwilling or inability to comply with the requirements for follow-up visits - Known allergy to any medications used during treatment - Known right to left circulatory shunt - Evidence of acute deep venous thrombosis or complete ipsilateral occlusion - Pelvic vein insufficiency - Active or recent thrombophlebitis (within 6 weeks) - Impalpable foot pulses with Ankle-Brachial Pressure Index of less than 0.8 - Pregnancy or breast feeding - Active malignancy - Immobility - Have been included in other CTIMP trials within the last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Randomised trials have established that closing veins using a heat source such as laser has significantly higher success rates than using chemicals, however heat treatment requires multiple additional uncomfortable injections of local anaesthetic. Recently a newer treatment mechanochemical ablation (MOCA) has been developed aiming to provide improved success rates similar to those seen with heat treatment, yet still avoid additional injections. This technology involves a spinning wire inside the vein which releases the chemical. The wire performs several actions which makes the vein more susceptible to the action of the chemical. Early non-randomised data suggests that MOCA may have similar success rates as heat, which seems very promising and this trial aims to randomly allocate patients to receive treatment with MOCA or with a popular heat method endovenous laser ablation (EVLA). The results can then be directly compared to see whether there are any differences in efficacy, ef;Secondary Objective: n/a;Primary end point(s): The joint primary outcomes will assess the hypothesised advantaged and disadvantages of mechanochemical ablation (MOCA) when compared with endovenous laser ablation (EVLA), the current first choice treatment of superficial venous insufficiency (SVI). The first will be patient reported intra-procedural pain measured on a standardised visual analogue scale (VAS). The second will be technical efficacy at 1 year, with successful procedure defined as complete occlusion of the target vein segment. This will be assessed during duplex ultrasound. Recanalisation at 1 year is defined as blood flow within the target vein that had been treated. This is broken down into partial <25% or full =25% of the length of the treated vein.;Timepoint(s) of evaluation of this end point: Patients will record their intra- and post-procedural pain on visual analogue scale (VAS). They will complete this immediately following axial treatment and again | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Disease specific quality of life using the Aberdeen Varicose Vein Questionnaire (AVVQ), the Chronic Venous Insufficiency Questionnaire (CIVIQ), and the VEnous INsufficiency Epidemiological and Economic Study to evaluate Quality of Life and Symptoms (VEINES-QOL/Sym). - Generic quality of life using the Short Form 36 (SF-36), EuroQol (EQ5D), and SF6D. - Bruising visual analogue scale on a 100mm unmarked scale. - Satisfaction visual analogue scale on a 100mm unmarked scale. - Cosmesis visual analogue scale on a 100mm unmarked scale. - Recovery time in terms of time taken to return to work and normal activities. - Clinical severity using the CEAP (Clinical severity, Etiology, Anatomy and Pathophysiology) classification, and Venous Clinical Severity Score (VCSS). - Complications - Surface planimetry of skin changes and complications estimated by measurement of tracing on acetate pre-printed with 1cm2 grids. - Duplex ultrasound to assess treatment efficacy. - Costs and resource use.;Timepoint(s) of evaluation of this end point: Patients will be followed up at 1 week, 6 weeks, 6 months and 1 year, during which they will be assessed for the secondary outcome measures. | — |
Countries
United Kingdom
Contacts
Public ContactDaniel Carradice
Hull and East Yorkshire Hospitals NHS Trust
Outcome results
None listed