Comparing foam sclerotherapy and ambulatory phlebectomy for varicose veins
Randomised Controlled Trial of Foam Sclerotherapy Versus Ambulatory Phlebectomy for the Treatment of Varicose Vein Tributaries
PHASE4 · Imperial College London · NCT03416413
This study is testing which treatment for varicose veins—foam sclerotherapy or ambulatory phlebectomy—works better for patients after their saphenous vein has been treated.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Imperial College London (other) |
| Locations | 1 site (London) |
| Trial ID | NCT03416413 on ClinicalTrials.gov |
What this trial studies
This study compares two treatment methods for varicose vein tributaries: foam sclerotherapy and ambulatory phlebectomy. Patients will be randomly assigned to receive one of the two treatments after their saphenous vein has been treated. The study will evaluate re-intervention rates, safety, patient experience, and cost-effectiveness of each approach. By analyzing these factors, the study aims to determine which treatment is more effective for patients with varicose veins.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 with symptomatic varicose vein reflux requiring treatment.
Not a fit: Patients with current deep vein thrombosis, recurrent varicose veins, or those preferring a specific treatment option may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify the more effective treatment option for patients suffering from varicose veins.
How similar studies have performed: Other studies have explored similar treatment comparisons, but the specific outcomes of this study may provide new insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults over 18 years of age * Symptomatic GSV or SSV vein reflux \> 0.5 seconds on colour Duplex * Varicose vein tributary requiring treatment Exclusion Criteria: * Current DVT * Recurrent varicose veins * Arterial disease (ABPI\<0.8) * Vein diameter \< 3mm * Preference for one of the treatment options * Patient who are unwilling to participate * Inability or unwillingness to complete questionnaires * Inability to attend follow-up appointments * Patient currently included in a study of varicose vein treatment
Where this trial is running
London
- Charing Cross Hospital, Imperial College London — London, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Amjad Belramman
- Email: a.belramman17@imperial.ac.uk
- Phone: 02033117335
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Varicose Veins