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
- Conditions
- Varicose Veins
- Registration Number
- NCT06667570
- Lead Sponsor
- Lidiane Rocha
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Vein Occlusion Rate at 30 Days 30 days post-procedure Vein occlusion will be measured using Doppler ultrasound to assess whether the treated veins are completely occluded, partially occluded, or not occluded at 30 days post-procedure.
- Secondary Outcome Measures
Name Time Method Hyperpigmentation Rate 7 and 30 days post-procedure Incidence of hyperpigmentation will be evaluated using a 4-point scale (1 = absent, 2 = mild, 3 = moderate, 4 = severe) at 7 and 30 days post-procedure.
Trial Locations
- Locations (1)
Hospital São Luiz Gonzaga
🇧🇷São Paulo, Brazil