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

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.

Study Overview

• Status: Completed
• Conditions: Varicose Veins
• Intervention / Treatment: Procedure: SALFOAM 3%; Procedure: Control Group

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • São Paulo, São Paulo, Brazil
      • Hospital São Luiz Gonzaga

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: SALFOAM 3%; Drug: Polidocanol 3%; Device: Lidstop®
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.	Procedure: Control Group; Drug: Polidocanol 3%; Device: Standard compression with dental roll and elastic stockings

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vein Occlusion Rate at 30 Days	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.	30 days post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hyperpigmentation Rate	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.	7 and 30 days post-procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event Rate	Incidence of adverse events, including thrombophlebitis, skin ulceration, and other complications, will be assessed through clinical and ultrasound evaluations.	7 and 30 days post-procedure
Quality of Life Improvement	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.	30 days post-procedure

Collaborators and Investigators

• Sponsor: Lidiane Rocha
• Collaborators: Lidiane Aparecida Ferreira Rocha

Publications and helpful links

General Publications

• Vasquez MA, Rabe E, McLafferty RB, Shortell CK, Marston WA, Gillespie D, Meissner MH, Rutherford RB; American Venous Forum Ad Hoc Outcomes Working Group. Revision of the venous clinical severity score: venous outcomes consensus statement: special communication of the American Venous Forum Ad Hoc Outcomes Working Group. J Vasc Surg. 2010 Nov;52(5):1387-96. doi: 10.1016/j.jvs.2010.06.161. Epub 2010 Sep 27.
• Hamel-Desnos CM, Guias BJ, Desnos PR, Mesgard A. Foam sclerotherapy of the saphenous veins: randomised controlled trial with or without compression. Eur J Vasc Endovasc Surg. 2010 Apr;39(4):500-7. doi: 10.1016/j.ejvs.2009.11.027. Epub 2010 Jan 25.
• Rutherford RB, Padberg FT Jr, Comerota AJ, Kistner RL, Meissner MH, Moneta GL. Venous severity scoring: An adjunct to venous outcome assessment. J Vasc Surg. 2000 Jun;31(6):1307-12. doi: 10.1067/mva.2000.107094.
• Danneil O, Dorler M, Stockfleth E, Stucker M. Factors influencing superficial and deep vein thrombosis after foam sclerotherapy in varicose veins. J Dtsch Dermatol Ges. 2022 Jul;20(7):929-938. doi: 10.1111/ddg.14748. Epub 2022 Jun 12.
• Wong M, Parsi K, Myers K, De Maeseneer M, Caprini J, Cavezzi A, Connor DE, Davies AH, Gianesini S, Gillet JL, Grondin L, Guex JJ, Hamel-Desnos C, Morrison N, Mosti G, Orrego A, Partsch H, Rabe E, Raymond-Martimbeau P, Schadeck M, Simkin R, Tessari L, Thibault PK, Ulloa JH, Whiteley M, Yamaki T, Zimmet S, Kang M, Vuong S, Yang A, Zhang L. Sclerotherapy of lower limb veins: Indications, contraindications and treatment strategies to prevent complications - A consensus document of the International Union of Phlebology-2023. Phlebology. 2023 May;38(4):205-258. doi: 10.1177/02683555231151350. Epub 2023 Mar 14.
• Watson JJ, Mansour MA. Cosmetic sclerotherapy. J Vasc Surg Venous Lymphat Disord. 2017 May;5(3):437-445. doi: 10.1016/j.jvsv.2017.02.002.
• De Maeseneer MG, Kakkos SK, Aherne T, Baekgaard N, Black S, Blomgren L, Giannoukas A, Gohel M, de Graaf R, Hamel-Desnos C, Jawien A, Jaworucka-Kaczorowska A, Lattimer CR, Mosti G, Noppeney T, van Rijn MJ, Stansby G, Esvs Guidelines Committee, Kolh P, Bastos Goncalves F, Chakfe N, Coscas R, de Borst GJ, Dias NV, Hinchliffe RJ, Koncar IB, Lindholt JS, Trimarchi S, Tulamo R, Twine CP, Vermassen F, Wanhainen A, Document Reviewers, Bjorck M, Labropoulos N, Lurie F, Mansilha A, Nyamekye IK, Ramirez Ortega M, Ulloa JH, Urbanek T, van Rij AM, Vuylsteke ME. Editor's Choice - European Society for Vascular Surgery (ESVS) 2022 Clinical Practice Guidelines on the Management of Chronic Venous Disease of the Lower Limbs. Eur J Vasc Endovasc Surg. 2022 Feb;63(2):184-267. doi: 10.1016/j.ejvs.2021.12.024. Epub 2022 Jan 11. No abstract available.
• Gloviczki P, Lawrence PF, Wasan SM, Meissner MH, Almeida J, Brown KR, Bush RL, Di Iorio M, Fish J, Fukaya E, Gloviczki ML, Hingorani A, Jayaraj A, Kolluri R, Murad MH, Obi AT, Ozsvath KJ, Singh MJ, Vayuvegula S, Welch HJ. The 2023 Society for Vascular Surgery, American Venous Forum, and American Vein and Lymphatic Society clinical practice guidelines for the management of varicose veins of the lower extremities. Part II: Endorsed by the Society of Interventional Radiology and the Society for Vascular Medicine. J Vasc Surg Venous Lymphat Disord. 2024 Jan;12(1):101670. doi: 10.1016/j.jvsv.2023.08.011. Epub 2023 Aug 29.

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2024
• Primary Completion (Actual): February 14, 2025
• Study Completion (Actual): February 14, 2025

Study Registration Dates

• First Submitted: October 28, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Actual): October 31, 2024

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Sclerotherapy; Varicose Veins; Chronic Venous Disease; Hyperpigmentation; Polidocanol Foam; SALFOAM 3%; Tessari Method; Vein Occlusion
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Skin Diseases; Pigmentation Disorders; Skin and Connective Tissue Diseases; Varicose Veins; Hyperpigmentation; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: SALFOAM 3%

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified individual participant data (IPD) will be shared after publication. Data sharing will include the study protocol, statistical analysis plan, and final dataset.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No