CompletedNot Applicable

Efficacy of the SALFOAM 3% Method Compared to the Conventional Polidocanol Foam Method (Tessari Method) for Treating Lower Limb Varicose Veins

Brazil35 participantsStarted 2024-10-25

Plain-language summary

This clinical trial aims to assess the efficacy and safety of the SALFOAM 3% method, which involves saline wash, polidocanol 3% foam injection, and extrinsic compression using Lidstop®, in comparison with the conventional Tessari method for the treatment of lower limb varicose veins. The primary objective is to determine whether the SALFOAM 3% method results in better or equivalent vein occlusion rates and fewer adverse effects, such as hyperpigmentation, compared to the standard treatment.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Vein Occlusion Rate at 30 Days

Timeframe: 30 days post-procedure

Trial details

NCT IDNCT06667570

SponsorLidiane Rocha

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-14

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