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

NCT06667570 | Completed DMC

• 1 other identifier: SALFOAM 3%
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Varicose Veins

Keywords

Chronic Venous Disease; Varicose Veins; Polidocanol Foam; Sclerotherapy; SALFOAM 3%; Tessari Method; Vein Occlusion; Hyperpigmentation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Hyperpigmentation Rate

  7 and 30 days post-procedure

Other Outcomes (2)

• Adverse Event Rate

  7 and 30 days post-procedure

• Quality of Life Improvement

  30 days post-procedure

Study Arms (2)

SALFOAM 3%

EXPERIMENTAL

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%

Tessari Method

ACTIVE COMPARATOR

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

Interventions

SALFOAM 3% PROCEDURE

* Drug: Polidocanol 3% * Device: Lidstop®

SALFOAM 3%

Control Group PROCEDURE

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

Tessari Method

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lidiane Rocha: lead

Study Sites (1)

Hospital São Luiz Gonzaga

São Paulo, São Paulo, Brazil

Location

Related Publications (8)

• 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.

  PMID: 35691945 BACKGROUND

• 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.

  PMID: 10842165 BACKGROUND

• 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.

  PMID: 36916540 BACKGROUND

• 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.

  PMID: 28411713 BACKGROUND

• 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.

  PMID: 37652254 BACKGROUND

• 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.

  PMID: 20875713 BACKGROUND

• 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.

  PMID: 20097585 BACKGROUND

• 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.

  PMID: 35027279 BACKGROUND

MeSH Terms

Conditions

Varicose Veins; Hyperpigmentation

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 31, 2024
• Study Start: October 25, 2024
• Primary Completion: February 14, 2025
• Study Completion: February 14, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)