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

Launched by LIDIANE ROCHA · Oct 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment method called SALFOAM 3% for lower limb varicose veins, which are swollen and twisted veins that can cause discomfort. The trial compares this new method to the traditional Tessari method, focusing on how well each treatment closes off the veins and their side effects. The researchers want to find out if SALFOAM 3% is just as effective or better, while also causing fewer problems like skin discoloration.

To join the trial, participants need to be adults aged 18 or older with confirmed varicose veins. It’s important that they can provide written consent and have no serious health issues that could complicate the treatment. During the trial, participants will receive either the SALFOAM 3% treatment or the standard method, and they will be monitored for effectiveness and any side effects. This trial is currently looking for volunteers, and everyone is welcome to apply, regardless of their skin type.

Gender

ALL

Eligibility 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.