Study Protocol Comparing Polidocanol Versus Hypertonic Glucose for Treatment of Reticular Veins

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

It will be done a randomized triple-blind study comparing 0,2% polidocanol versus 75% hypertonic glucose of sclerotherapy in lower limbs´ reticular veins. It will be included only adult women with reticular veins on the side of the thighs and mild venous insufficiency (CEAP 1). The primary endpoint will be efficacy, and secondary will be safety.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UPECLIN HC FM Botucatu Unesp
• Collaborator: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Treatments: Polidocanol

Criteria

Inclusion Criteria:

• females

• with at least 10 cm from the lateral reticular veins of the leg or thigh of the leg

• clinical classification of chronic venous disease C1(mild venous disease),

• minimum age of 18 year-old and maximum age 69 year-old

• agreement with the study

• signing the free and informed consent ( IC)

• not use anticoagulant drugs .

Exclusion Criteria:

• male

• varicose disease in any quantity or location with clinical classification of chronic venous disease different of C1(mild venous disease)

• restrict mobility

• arterial insufficiency

• be allergic to any substance that may be related to the study drugs

• any cause of dermatitis on application site

• free of comorbidities clinically serious as diabetes mellitus, heart failure, respiratory failure, uncontrolled hypertension with medication, and uncontrolled hypothyroidism

• pregnancy

• previous deep vein thrombosis (DVT)

• family history of DVT

• thrombophilia

• do not agree with the search terms