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

Lidiane Rocha

Status: Completed

Conditions: Varicose Veins

Treatments: Procedure: SALFOAM 3%; Procedure: Control Group

Study type: Interventional

Funder types: Other

Identifiers

NCT06667570

SALFOAM 3%

Details and patient eligibility

About

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.

Full description

Chronic venous disease (CVD) is prevalent in approximately 38% of the adult population in Brazil, posing significant public health challenges due to its potential complications, including ulcerations and reduced quality of life. The SALFOAM 3% method is a novel approach that combines saline wash prior to polidocanol 3% foam sclerotherapy and extrinsic compression with Lidstop®, aiming to improve outcomes by reducing adverse effects such as hyperpigmentation and enhancing patient quality of life. This randomized controlled trial will compare the efficacy, safety, and quality of life outcomes of patients treated with the SALFOAM 3% method versus those treated with the conventional Tessari method for lower limb varicose veins.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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35 participants in 2 patient groups

SALFOAM 3%

Experimental group

Description:

Participants in this group will receive a saline wash, followed by an injection of polidocanol 3% foam using the Tessari method, and extrinsic compression with Lidstop® over the treated vein. This is followed by the application of elastic compression stockings (20-30 mmHg) for 72 hours.

Treatment:

Procedure: SALFOAM 3%

Tessari Method

Active Comparator group

Description:

Participants in this group will receive the conventional Tessari method of polidocanol 3% foam injection, followed by compression with a dental roll and elastic compression stockings (20-30 mmHg) for 24 hours.

Treatment:

Procedure: Control Group