Comparing two methods for treating varicose veins
Randomized Controlled Trial to Evaluate the Efficacy of the SALFOAM 3% Method Compared to the Conventional Polidocanol Foam Method (Tessari Method) for Treating Lower Limb Varicose Veins
This study is testing a new way to treat varicose veins using a special foam method to see if it works better and causes fewer side effects than the standard treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Science Valley Research Institute Academic / other |
| Locations | 1 site (São Paulo) |
| Trial ID | NCT06667570 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of the SALFOAM 3% method, which combines saline wash and polidocanol 3% foam injection with extrinsic compression, against the conventional Tessari method for treating lower limb varicose veins. The study aims to determine if the SALFOAM 3% method provides better vein occlusion rates and fewer adverse effects, such as hyperpigmentation. It involves adults with clinically confirmed varicose veins and will assess both treatment outcomes and patient quality of life.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with clinically confirmed varicose veins in the lower limbs.
Not a fit: Patients who are pregnant, breastfeeding, or have known allergies to polidocanol may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with varicose veins, enhancing their quality of life and reducing adverse effects.
How similar studies have performed: Other studies have shown promising results with similar sclerotherapy approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 years or older with clinically confirmed varicose veins in the lower limbs by ultrasonography. * All Fitzpatrick skin types (I-VI). * Ability to provide written informed consent. Exclusion Criteria: * Pregnancy or breastfeeding. * Known allergy or adverse reaction to polidocanol or similar agents. * Active infection in the area of treatment. * Immunosuppressed patients. * Severe coagulopathies or a history of recent deep vein thrombosis or pulmonary embolism. * Diagnosis of patent foramen ovale. * CEAP classification VI (active venous ulcers). * Use of medications that may interfere with the study outcomes. * Inability to comply with the study protocol or refusal to participate.
Where this trial is running
São Paulo
- Hospital São Luiz Gonzaga — São Paulo, Brazil (Recruiting)
Study contacts
- Study coordinator: Lidiane Rocha, MD
- Email: dralidianerocha@gmail.com
- Phone: +55 11 99-112-6991
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.