Varicose Veins
Conditions
Brief 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. 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.
Interventions
Polidocanol foam prepared using the Tessari method. Concentration 0,5% (Foam Arm) or 0,25% (Foam + Laser Arm), injected under ultrasound guidance.
DEVICETransdermal Nd:YAG 1064 nm laser
Long-pulse Nd:YAG 1064 nm transdermal laser applied along the treated vein path immediately after foam injection.
Sponsors
Hospital Universitario Pedro Ernesto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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 * 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Venous occlusion rate at 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Venous occlusion rate at 90 days | 90 days after the first session | 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. |
| Final venous occlusion rate at 180 days | 180 days after the first session | 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. |
| Pain intensity immediately after the procedure | Immediately after the procedure (within 30 minutes) | 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. |
| Hyperpigmentation at the treated site | 30, 90, and 180 days after the first session. | 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. |
| Number of treatment sessions required | Up to 90 days after the first session. | Total number of sessions needed to achieve venous occlusion according to the study protocol (maximum of two sessions). |
| Patient-reported aesthetic satisfaction | Assessed at 90 days after the first session. | Patient global assessment of cosmetic improvement using a 5-point Likert scale (from "no improvement" to "complete improvement"). |
Countries
Brazil
Contacts
CONTACTJuliana de Miranda Vieira, PhD
PRINCIPAL_INVESTIGATORJuliana Vieira, PhD
Hospital Universitário Pedro Ernesto - UERJ
Outcome results
None listed