Polidocanol Foam With or Without Transdermal Laser in Varicose Veins
ConditionVaricose Veins
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-75
SponsorHospital Universitario Pedro Ernesto
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Polidocanol foam sclerotherapy
- Transdermal Nd:YAG 1064 nm laser
Treatment groups
102 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov