Efficacy of the SALFOAM 3% Method Compared to the Conventional Polidocanol Foam Method (Tessari M… (NCT06667570) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of the SALFOAM 3% Method Compared to the Conventional Polidocanol Foam Method (Tessari Method) for Treating Lower Limb Varicose Veins
Brazil35 participantsStarted 2024-10-25
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.