ISRCTN91735422RecruitingNot Applicable
A three-arm, parallel group, randomised controlled trial of patients with small saphenous vein insufficiency treated with either endovascular laser, ultrasound-guided foam sclerotherapy, or conventional surgery
Åreknudeklinikken (Denmark)0 sites330 target enrollmentStarted: July 8, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 330
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Age: 18-75
- •2. Informed approval
- •3. Varicose veins with symptoms, and reflux in Small Saphenous Vein defined as 0,5 seconds reflux after manual compression of the calf while standing
- •4. Clinical, Etiologic, Anatomic and Pathophysiologic (CEAP) classification C2-C4
- •5. Bilateral treatment is allowed when the same treatment is given to both legs during the same intervention
Exclusion Criteria
- •1. Deep Venous Thrombosis (DVT) of the leg
- •2. Insufficient popliteal perforants
- •3. Previous varicose surgery in the popliteal area
- •4. Age under 18
- •5. Contradictions against use of Aethoxysklerol®
- •6. Great saphenous vein insuffienciency at the same time or surgery for Great Saphenous vein insufficiency < 3 months previously
- •7. History or foot-pulse indicating arterial insufficiency or/and ankle/arm index <0.9
- •8. Convoluted or disrupted Parva, that will make it inappropriate for the treatments
- •9. Other anatomical relations that will make surgery difficult
- •10. Pregnant or have given birth < 3 months previously
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