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

NCT06667570 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-11-25

No results posted yet for this study

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.

Conditions

  • Varicose Veins

Interventions

PROCEDURE

SALFOAM 3%

* Drug: Polidocanol 3% * Device: Lidstop®

PROCEDURE

Control Group

* Drug: Polidocanol 3% * Device: Standard compression with dental roll and elastic stockings

Sponsors & Collaborators

  • Lidiane Rocha

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-25
Primary Completion
2025-02-14
Completion
2025-02-14

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06667570 on ClinicalTrials.gov