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
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Brazil
Hospital São Luiz Gonzaga
RECRUITING
São Paulo
Contact Information
Primary
Lidiane Rocha, MD
dralidianerocha@gmail.com
+55 11 99-112-6991
Backup
Eduardo Ramacciotti, MD, PhD
eduardoramacciotti@gmail.com
+55 11 4040-8670
Time Frame
Start Date: 2024-10-18
Estimated Completion Date: 2025-03-31
Participants
Target number of participants: 30
Treatments
Experimental: SALFOAM 3%
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.
Active_comparator: Tessari Method
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.
Related Therapeutic Areas
Sponsors
Collaborators: Lidiane Aparecida Ferreira Rocha
Leads: Lidiane Rocha