Study comparing two treatments with Laser for Lower Limb Microvarices

Not Applicable

• Conditions: Asymptomatic varicose veins of lower extremities; C14.907.927

• Registration Number: RBR-949wrsh
• Lead Sponsor: Clinica Prime Vascular

Brief Summary

BACKGRAUND: Chemical sclerotherapy is a procedure used to treat varicose veins. Hybrid procedures appear to increase the effectiveness of the treatment. Few publications compare its association with the Nd: YAG laser. The objective of this study was to evaluate the treatment of reticular veins and telangiectasias at the lower limbs with the association of transdermal laser and two sclerosing solutions. PATIENTS AND METHODS: Prospective, randomized, triple-blinded study in 51 lower limbs between January and March 2021, in women aged 18 to 70 years, who presented telangiectasias and reticular veins on the lateral face of the thigh of the lower limbs. Participants were randomized into two treatment groups: Laser Nd:YAG 1064 associated with Sclerotherapy with Glucose 75% and Laser associated with Glucose solution 67.5% + Polidocanol 0.3%. A photographic record was performed prior to treatment and in 30 days for comparison and analysis by two independent vascular surgeons. Complications such as dyschromia, skin ulcers, bruises, matting and phlebitis were also evaluated. RESULTS: The association of laser and sclerotherapy with a 67.5% glucose solution plus 0.3% Polidocanol showed superiority in relation to the use of a transdermal laser with a 75% glucose solution (P<0.05) in the treatment of reticular veins, but with no difference for the treatment of telangiectasias. No unexpected adverse effects were found and 86.3% of patients declared results to be very good or excellent. CONCLUSION: The association of Nd:YAG laser to sclerotherapy with 67.5% Glucose solution + 0.3% Polidocanol was superior for the treatment of reticular veins.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-04-28
• Study Start: 2023-01-09
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Volunteers women; aged between 18 and 70 years; reticular veins and telangiectasias; without reflux of the deep venous or saphenous system; Fitzpatrick Skin Type I, II or III; Patients should have at least one reticular vein with a minimum length of 5 cm in one of the lower limbs on the lateral side of the thigh.

Exclusion Criteria

Venous disease CEAP class greater than C1; who underwent procedure with sclerotherapy or transdermal laser in the last 12 months; skin classification Fitzpatrick IV, V or VI; pregnancy or puerperium; known allergy; peripheral arterial disease; diabetes; dermatitis at the treatment site; asthma; migraine; deep or superficial deep vein thrombosis (DVT); family history of DVT; known thrombophilia or any hypercoagulable state and use of anticoagulants.

Study & Design

• Study Type: Intervention
• Study Design: Not specified