An interventional study of SALFOAM 3% and Control Group in Varicose Veins, sponsored by Lidiane Rocha. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-25.
Sponsored by Lidiane Rocha · Not applicable, Interventional, and Treatment
Among 11 studies in Varicose Veins with a site in Brazil — 2 open to participants now, 2 under way, none of them phase 3. Varicose Veins · Brazil.
Among the 11 studies in Varicose Veins with a site in Brazil, this one is the 9th largest by enrollment, is the only one that started in 2024, is one of 5 with no phase, and was the 8th registered.
226 studies on the registry are indexed under Varicose Veins; 30 are open to participants now.
Browse Varicose Veins studies →2 of the 11 studies in Varicose Veins with a site in Brazil are open now. Recruiting first, the newest first:
Antonio Eduardo Zerati · Sites in Brazil
Hospital Universitario Pedro Ernesto · Sites in Brazil
A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →
Of the 22 Varicose Veins studies recruiting now, 12 (55%) set no upper age limit and 4 (18%) stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 1 started in 2024.
This study's enrollment of 35 is below the median of 101 across 154 interventional studies indexed under Varicose Veins.
Median enrollment 60 across the 11 interventional studies. Of the 5 that completed or were terminated, 2 (40%) have results posted.
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2 of 11 have an industry lead sponsor. The 9 most frequent:
This is the only study on the registry with Lidiane Rocha as lead sponsor.
Lidiane Rocha has 1 study filed under Varicose Veins — fewer than ten, so there is no comparison to draw.
2 of the studies in Varicose Veins with a site in Brazil that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07561320Antonio Eduardo ZeratiMechanochemical Ablation Versus Ultrasound-Guided Foam Sclerotherapy of the Great Saphenous Vein | 2027-08 |
| NCT07276243Hospital Universitario Pedro ErnestoPolidocanol Foam With or Without Transdermal Laser in Varicose Veins | 2027-08-30 |
Among the 11 studies in Varicose Veins with a site in Brazil, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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%
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: Lidstop®
* Drug: Polidocanol 3% * Device: Standard compression with dental roll and elastic stockings
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.
Time frame: 30 days post-procedure
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.
Time frame: 7 and 30 days post-procedure
Adverse Event Rate
Incidence of adverse events, including thrombophlebitis, skin ulceration, and other complications, will be assessed through clinical and ultrasound evaluations.
Time frame: 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.
Time frame: 30 days post-procedure
Plan to share: 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.
Ran from Oct 2024 to primary completion in Feb 2025, 3 months.
Of 62 non-industry interventional studies with no phase under Varicose Veins, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's 3 months is below that.
Counting every sponsor, half of 72 studies reached it within 22 months; a quarter within 11 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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