Varicose VeinsSALFOAM 3%NCT06667570
Efficacy of the SALFOAM 3% Method Compared to the Conventional Polidocanol Foam Method (Tessari Method) for Treating Lower Limb Varicose Veins
A study testing SALFOAM 3% in people with Varicose Veins, run by Lidiane Rocha at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Veins
- What is being tested?
- SALFOAM 3%
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Oct 2024to 14 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Varicose Veins
- Being tested
- SALFOAM 3%, Control Group
- Keywords
- Chronic Venous Disease, Varicose Veins, Polidocanol Foam, Sclerotherapy, SALFOAM 3%, Tessari Method, Vein Occlusion, Hyperpigmentation
- Medical subject headings
- Varicose Veins, Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SALFOAM 3%Procedure or surgery
- Drug: Polidocanol 3%
- Device: Lidstop®
Control GroupProcedure or surgery
- Drug: Polidocanol 3%
- Device: Standard compression with dental roll and elastic stockings
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days post-procedure
Secondary outcomes (1)
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.
Measured: 7 and 30 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start25 Oct 2024
- Primary completion14 Feb 2025
- Study completion14 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lidiane Rocha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lidiane Rocha, Science Valley Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667570
- Sponsor's protocol ID
- SALFOAM 3%
- Acronym
- SALFOAM 3%
- Status last verified
- Nov 2025
- First submitted
- 28 Oct 2024
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data (IPD) will be shared after publication. Data sharing will include the study protocol, statistical analysis plan, and final dataset.
Publications
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.
PubMed 35691945Rutherford 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.
PubMed 10842165Wong 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.
PubMed 36916540Watson 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.
PubMed 28411713Gloviczki 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.
PubMed 37652254Vasquez 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.
PubMed 20875713Hamel-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.
PubMed 20097585De 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.
PubMed 35027279
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the SALFOAM 3% Method Compared to the Conventional Polidocanol Foam Method (Tessari Method) for Treating Lower Limb Varicose Veins
- ClinicalTrials.gov ID
- NCT06667570
- Acronym / sponsor ID
- SALFOAM 3% / SALFOAM 3%
- Conditions
- Varicose Veins
- Keywords
- Chronic Venous Disease, Varicose Veins, Polidocanol Foam, Sclerotherapy, SALFOAM 3%, Tessari Method, Vein Occlusion, Hyperpigmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Lidiane RochaUniversity, hospital or other
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- 14 Feb 2025 (actual)
- Study completion
- 14 Feb 2025 (actual)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SALFOAM 3% | Experimental | Procedure: 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. |
| Tessari Method | Active comparator | Procedure: Control GroupParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SALFOAM 3%* Drug: Polidocanol 3% * Device: Lidstop® | Procedure or surgery | SALFOAM 3% |
| Control Group* Drug: Polidocanol 3% * Device: Standard compression with dental roll and elastic stockings | Procedure or surgery | Tessari Method |
Primary outcome
Vein Occlusion Rate at 30 Days
Time frame: 30 days post-procedure
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.
1 secondary outcome
Hyperpigmentation Rate
Time frame: 7 and 30 days post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Background: PubMed 35691945Danneil 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.
- Background: PubMed 10842165Rutherford 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.
- Background: PubMed 36916540Wong 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.
- Background: PubMed 28411713Watson 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.
- Background: PubMed 37652254Gloviczki 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.
- Background: PubMed 20875713Vasquez 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.
- Background: PubMed 20097585Hamel-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.
- Background: PubMed 35027279De 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.
- Individual participant dataSharing planned: No. De-identified individual participant data (IPD) will be shared after publication. Data sharing will include the study protocol, statistical analysis plan, and final dataset.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SALFOAM 3% in people with Varicose Veins, run by Lidiane Rocha at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vein Occlusion Rate at 30 Days (time frame: 30 days post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06667570, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.