Clinical trial NCT06667570: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Varicose Veins
Keywords: Chronic Venous Disease
Varicose Veins
Polidocanol Foam
Sclerotherapy
SALFOAM 3%
Tessari Method
Vein Occlusion
Hyperpigmentation
Lead sponsor: Science Valley Research Institute
Sponsor class: OTHER
Collaborators: name: Lidiane Aparecida Ferreira Rocha
First posted: 2024-10-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: Vein Occlusion Rate at 30 Days
timeFrame: 30 days post-procedure
Secondary outcomes:
measure: Hyperpigmentation Rate
timeFrame: 7 and 30 days post-procedure
Other outcomes:
measure: Adverse Event Rate
timeFrame: 7 and 30 days post-procedure
measure: Quality of Life Improvement
timeFrame: 30 days post-procedure
Locations:
city: São Paulo
country: Brazil
facility: Hospital São Luiz Gonzaga
Study officials:
References:
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