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
NCT ID: NCT06667570
Last Updated: 2024-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
30 participants
INTERVENTIONAL
2024-10-18
2025-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
SALFOAM 3%
* Drug: Polidocanol 3%
* Device: Lidstop®
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.
Control Group
* Drug: Polidocanol 3%
* Device: Standard compression with dental roll and elastic stockings
Interventions
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SALFOAM 3%
* Drug: Polidocanol 3%
* Device: Lidstop®
Control Group
* Drug: Polidocanol 3%
* Device: Standard compression with dental roll and elastic stockings
Eligibility Criteria
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Inclusion Criteria
* All Fitzpatrick skin types (I-VI).
* Ability to provide written informed consent.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Lidiane Aparecida Ferreira Rocha
UNKNOWN
Lidiane Rocha
OTHER
Responsible Party
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Lidiane Rocha
MD
Locations
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Hospital São Luiz Gonzaga
São Paulo, , Brazil
Countries
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Central Contacts
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Facility Contacts
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Eduardo Ramacciotti, MD. PhD
Role: primary
References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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SALFOAM 3%
Identifier Type: -
Identifier Source: org_study_id