Varicose VeinsFOAM-LASERNCT07276243
Polidocanol Foam With or Without Transdermal Laser in Varicose Veins
A study testing Polidocanol foam sclerotherapy and Transdermal Nd:YAG 1064 nm laser in people with Varicose Veins, run by Hospital Universitario Pedro Ernesto at 1 site in Brazil.
Trial summary
This randomized, parallel clinical trial with blinded outcome assessment will compare the clinical and aesthetic outcomes of polidocanol foam sclerotherapy alone versus polidocanol foam associated with long-pulse 1064 nm Nd:YAG transdermal laser in the treatment of lower-limb tributary varicose veins. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Varicose Veins
- What is being tested?
- Polidocanol foam sclerotherapy and Transdermal Nd:YAG 1064 nm laser
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteBrazil
- Study dates
- 24 Mar 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 to 75 years
- CEAP clinical class 1-3
- Lower limb tributary varicose veins 2,5 to 4,0 mm in diameter on Doppler ultrasound.
- Vein depth up to 4 mm from the skin surface.
- Tributary vein may originate from the great or small saphenous vein as long as the saphenous vein is competent on Doppler.
- Reflux limited to the target tributary.
- Body mass index (BMI) < 35 km²/m²
- Able and willing to provide informed consent.
Who cannot join
- CEAP clinical class ≥ 4
- Axial reflux of the great or small saphenous vein requiring prior treatment
- Tributary vein diameter < 2.5 mm or > 4.0 mm on Doppler
- Tributary vein depth > 4 mm from the skin surface
- Pregnancy or breastfeeding
- Known allergy or hypersensitivity to polidocanol
Show all 13Show fewer
- History of deep vein thrombosis or pulmonary embolism in the last 6 months
- Use of anticoagulant therapy that cannot be safely interrupted
- Active skin infection or ulcer at the treatment site
- Autoimmune or connective tissue disease with active vasculitis
- BMI ≥ 35 kg/m²
- Inability to comply with follow-up visits
- Previous treatment of the target vein in the past 6 months (laser, foam, surgery, or microphlebectomy).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Universitário Pedro Ernesto - UERJ
Rio de Janeiro, Rio de Janeiro, 20551-030
Juliana de Miranda Vieira, PhD, + 55 21 999722885, juliana.vieira@hupe.uerj.br
About this study
Official title: Comparação da eficácia clínica e estética Entre o Tratamento de Varizes Com Espuma de Polidocanol Associada ou não ao Laser transdérmico: Ensaio clínico Randomizado
This randomized, parallel clinical trial with blinded outcome assessment will compare the clinical and aesthetic outcomes of polidocanol foam sclerotherapy alone versus polidocanol foam associated with long-pulse 1064 nm Nd:YAG transdermal laser in the treatment of lower-limb tributary varicose veins. The primary endpoint is venous occlusion rate at 30 days, assessed by Doppler ultrasound. Secondary outcomes include cutaneous hyperpigmentation, pain, patient satisfaction, and adverse events.
Read the detailed description
The study aims to evaluate whether the association of transdermal Nd:YAG 1064 nm laser with polidocanol foam improves venous occlusion and aesthetic outcomes compared to foam alone. Participants will be adult patients with lower limb varicose veins CEAP 1-3 confirmed by Doppler ultrasound. After randomization (1:1), the control group will receive 0.5% polidocanol foam, while the intervention group will receive 0.25% polidocanol foam followed by transdermal laser application. A second session will be performed only if partial occlusion persists at the 30-day follow-up. Assessments will include venous occlusion at 30, 90 and 180 days after the procedure, pigmentation, pain intensity, number of sessions required, patient satisfaction, and adverse events. Standardized photographs will be taken at baseline, 30, 90 and 180 days.
- Conditions
- Varicose Veins
- Being tested
- Polidocanol foam sclerotherapy, Transdermal Nd:YAG 1064 nm laser
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polidocanol foam sclerotherapyDrug
Polidocanol foam prepared using the Tessari method. Concentration 0,5% (Foam Arm) or 0,25% (Foam + Laser Arm), injected under ultrasound guidance.
Transdermal Nd:YAG 1064 nm laserDevice
Long-pulse Nd:YAG 1064 nm transdermal laser applied along the treated vein path immediately after foam injection.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Foam only | Active comparator | Polidocanol 0,5% foam prepared with 1 mL of sclerosant and 3 mL of room air, injected under visualization of reticular vein (5 - 8 mL total). Receives: Drug: Polidocanol foam sclerotherapy |
| Group B: Foam + Laser | Experimental | Polidocanol 0,25% foam (1 mL of sclerosant + 2 mL of room air) followed within 2 minutes by long-pulse Nd:YAG 1064 nm laser (spot 6 mm; pulse 20-30 ms; fluence 60-70 J/cm²), with skin cooling. Receives: Drug: Polidocanol foam sclerotherapy; Device: Transdermal Nd:YAG 1064 nm laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous occlusion rate at 30 days
Ultrasound assessment of the treated vein segment 30 days after the first session, defined as complete absence of detectable flow in the treated vein or partial occlusion with significant reduction in reflux and/or venous diameter, and performed by an independent physician who is blinded to group assignment and not involved in the treatment procedures.
Measured: 30 days after the first session
Secondary outcomes (6)
Venous occlusion rate at 90 days
Ultrasound assessment of the treated vein segment 90 days after the first session, defined as complete occlusion or partial occlusion with improvement inreflux and/or reduction in venous diameter, and performed by an independent physician who is blinded to group assignment and not involved in the treatment procedures.
Measured: 90 days after the first session
Final venous occlusion rate at 180 days
Ultrasound assessment of the treated vein segment 180 days after the first session, defined as complete absence of detectable flow in the treated vein or partial occlusion with significant reduction in reflux and/or venous diameter, and performed by an independent physician who is blinded to group assignment and not involved in the treatment procedures.
Measured: 180 days after the first session
Pain intensity immediately after the procedure
Participant-reported pain intensity in the treated limb, measured immediately after the session, using a 10-cm Visual Analog Scale (VAS). Higher scores indicate greater pain.
Measured: Immediately after the procedure (within 30 minutes)
Hyperpigmentation at the treated site
Skin hyperpigmentation will be assessed by an independent physician blinded to the treatment allocation, using standardized comparative photographs obtained at baseline, 30 days, 90 days, and 180 days.
Measured: 30, 90, and 180 days after the first session.
Number of treatment sessions required
Total number of sessions needed to achieve venous occlusion according to the study protocol (maximum of two sessions).
Measured: Up to 90 days after the first session.
Patient-reported aesthetic satisfaction
Patient global assessment of cosmetic improvement using a 5-point Likert scale (from "no improvement" to "complete improvement").
Measured: Assessed at 90 days after the first session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start24 Mar 2026
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Pedro Ernesto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juliana de Miranda Vieira, Hospital Universitario Pedro Ernesto
- Investigators
- Juliana Vieira, PhD, Principal investigator, Hospital Universitário Pedro Ernesto - UERJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276243
- Sponsor's protocol ID
- HUPE-Varizes-Laser-2026
- Acronym
- FOAM-LASER
- Status last verified
- Apr 2026
- First submitted
- 28 Nov 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study will not share individual particiapnt data (IPD). Aggregate results will be published in scientific journals.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparação da eficácia clínica e estética Entre o Tratamento de Varizes Com Espuma de Polidocanol Associada ou não ao Laser transdérmico: Ensaio clínico Randomizado
- ClinicalTrials.gov ID
- NCT07276243
- Acronym / sponsor ID
- FOAM-LASER / HUPE-Varizes-Laser-2026
- Conditions
- Varicose Veins
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Hospital Universitario Pedro ErnestoUniversity, hospital or other
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 10 Dec 2025 (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 randomized, parallel clinical trial with blinded outcome assessment will compare the clinical and aesthetic outcomes of polidocanol foam sclerotherapy alone versus polidocanol foam associated with long-pulse 1064 nm Nd:YAG transdermal laser in the treatment of lower-limb tributary varicose veins. The primary endpoint is venous occlusion rate at 30 days, assessed by Doppler ultrasound. Secondary outcomes include cutaneous hyperpigmentation, pain, patient satisfaction, and adverse events.
Detailed description
The study aims to evaluate whether the association of transdermal Nd:YAG 1064 nm laser with polidocanol foam improves venous occlusion and aesthetic outcomes compared to foam alone. Participants will be adult patients with lower limb varicose veins CEAP 1-3 confirmed by Doppler ultrasound. After randomization (1:1), the control group will receive 0.5% polidocanol foam, while the intervention group will receive 0.25% polidocanol foam followed by transdermal laser application. A second session will be performed only if partial occlusion persists at the 30-day follow-up. Assessments will include venous occlusion at 30, 90 and 180 days after the procedure, pigmentation, pain intensity, number of sessions required, patient satisfaction, and adverse events. Standardized photographs will be taken at baseline, 30, 90 and 180 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Foam only | Active comparator | Drug: Polidocanol foam sclerotherapyPolidocanol 0,5% foam prepared with 1 mL of sclerosant and 3 mL of room air, injected under visualization of reticular vein (5 - 8 mL total). |
| Group B: Foam + Laser | Experimental | Drug: Polidocanol foam sclerotherapy, Device: Transdermal Nd:YAG 1064 nm laserPolidocanol 0,25% foam (1 mL of sclerosant + 2 mL of room air) followed within 2 minutes by long-pulse Nd:YAG 1064 nm laser (spot 6 mm; pulse 20-30 ms; fluence 60-70 J/cm²), with skin cooling. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 21 to 75 years
- CEAP clinical class 1-3
- Lower limb tributary varicose veins 2,5 to 4,0 mm in diameter on Doppler ultrasound.
- Vein depth up to 4 mm from the skin surface.
- Tributary vein may originate from the great or small saphenous vein as long as the saphenous vein is competent on Doppler.
Key exclusion criteria (13 listed)
- CEAP clinical class ≥ 4
- Axial reflux of the great or small saphenous vein requiring prior treatment
- Tributary vein diameter < 2.5 mm or > 4.0 mm on Doppler
- Tributary vein depth > 4 mm from the skin surface
- Pregnancy or breastfeeding
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 |
|---|---|---|
| Polidocanol foam sclerotherapyPolidocanol foam prepared using the Tessari method. Concentration 0,5% (Foam Arm) or 0,25% (Foam + Laser Arm), injected under ultrasound guidance. | Drug | Group A: Foam only, Group B: Foam + Laser |
| Transdermal Nd:YAG 1064 nm laserLong-pulse Nd:YAG 1064 nm transdermal laser applied along the treated vein path immediately after foam injection. | Device | Group B: Foam + Laser |
Primary outcome
Venous occlusion rate at 30 days
Time frame: 30 days after the first session
Ultrasound assessment of the treated vein segment 30 days after the first session, defined as complete absence of detectable flow in the treated vein or partial occlusion with significant reduction in reflux and/or venous diameter, and performed by an independent physician who is blinded to group assignment and not involved in the treatment procedures.
6 secondary outcomes
Venous occlusion rate at 90 days
Time frame: 90 days after the first session
Final venous occlusion rate at 180 days
Time frame: 180 days after the first session
Pain intensity immediately after the procedure
Time frame: Immediately after the procedure (within 30 minutes)
Hyperpigmentation at the treated site
Time frame: 30, 90, and 180 days after the first session.
Number of treatment sessions required
Time frame: Up to 90 days after the first session.
Patient-reported aesthetic satisfaction
Time frame: Assessed at 90 days after the first session.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No. The study will not share individual particiapnt data (IPD). Aggregate results will be published in scientific journals.
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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.
Juliana Vieira, PhD principal investigator
Hospital Universitário Pedro Ernesto - UERJ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polidocanol foam sclerotherapy and Transdermal Nd:YAG 1064 nm laser in people with Varicose Veins, run by Hospital Universitario Pedro Ernesto 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 8 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 5 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juliana de Miranda Vieira, PhD (+ 55 21 99972 2885, juliana.vieira@hupe.uerj.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous occlusion rate at 30 days (time frame: 30 days after the first session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 May 2026.