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Clinical Trials/RBR-949wrsh
RBR-949wrsh
Active, not recruiting
未知

Transdermal Laser Association comparing two treatments of Sclerotherapy for the Treatment of Unesthetic Veins of Lower Limbs: Triple Blind Randomized Clinical Trial

Clinica Prime Vascular0 sitesJanuary 9, 2023

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Clinica Prime Vascular
Status
Active, not recruiting
Last Updated
2 years ago

Overview

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.

Registry
who.int
Start Date
January 9, 2023
End Date
April 28, 2021
Last Updated
2 years ago
Study Type
Intervention
Sex
Female

Investigators

Sponsor
Clinica Prime Vascular

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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