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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polidocanol foam sclerotherapy | Drug | Polidocanol foam prepared using the Tessari method. Concentration 0,5% (Foam Arm) or 0,25% (Foam + Laser Arm), injected under ultrasound guidance. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days after the first session |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 days after the first session |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juliana de Miranda Vieira, PhD | Contact | + 55 21 99972 2885 | juliana.vieira@hupe.uerj.br |
| Name | Affiliation | Role |
|---|---|---|
| Juliana Vieira, PhD | Hospital Universitário Pedro Ernesto - UERJ | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitário Pedro Ernesto - UERJ | Recruiting | Rio de Janeiro | Rio de Janeiro | 20551-030 | Brazil |
The study will not share individual particiapnt data (IPD). Aggregate results will be published in scientific journals.
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| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D007834 | Lasers |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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Randomization will be performed in a 1:1 ratio using a concealed allocation sequence accessible only at the time of treatment by a staff member not involved in outcome assessment.
| Transdermal Nd:YAG 1064 nm laser | Device | Long-pulse Nd:YAG 1064 nm transdermal laser applied along the treated vein path immediately after foam injection. |
|
| 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. | 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. | 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. | 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). | 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"). | Assessed at 90 days after the first session. |