Varicose Veins
Conditions
Keywords
Chronic Venous Disease, Varicose Veins, Polidocanol Foam, Sclerotherapy, SALFOAM 3%, Tessari Method, Vein Occlusion, Hyperpigmentation
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.
Interventions
PROCEDURESALFOAM 3%
* Drug: Polidocanol 3% * Device: Lidstop®
PROCEDUREControl Group
* Drug: Polidocanol 3% * Device: Standard compression with dental roll and elastic stockings
Sponsors
Lidiane Rocha
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event Rate | 7 and 30 days post-procedure | Incidence of adverse events, including thrombophlebitis, skin ulceration, and other complications, will be assessed through clinical and ultrasound evaluations. |
| Quality of Life Improvement | 30 days post-procedure | Measured using the revised Venous Clinical Severity Score (rVCSS) to assess changes in the quality of life of participants at 30 days post-procedure. The total score ranges from a minimum of 0 to a maximum of 30 for a single limb. Minimum score: 0. This indicates the complete absence of symptoms or signs for all 10 characteristics. Maximum score: 30. This indicates the most severe symptoms and signs across all 10 characteristics. |
Countries
Brazil
Outcome results
None listed