Phase 4
N=106
Study Protocol Comparing Polidocanol Versus Hypertonic Glucose for Treatment of Reticular Veins
Varicose Veins
Bottom Line
View on ClinicalTrials.gov: NCT02054325 ↗Enrolled (actual)
106
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Efficacy in Treating Reticular Veins by Photographs: Mean Percent Reticular Vein Disappearance Two Months After Treatment. — 95.17; 85.40 % of Reticular Veins that Disappeared
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Polidocanol with Glucose (Drug); Glucose (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- UPECLIN HC FM Botucatu Unesp
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy in Treating Reticular Veins by Photographs: Mean Percent Reticular Vein Disappearance Two Months After Treatment. |
95.17; 85.40 | — |
| SECONDARY The Safety of the Treatment: Mean Percent of Skin Hyperpigmentation Two Months After Treatment |
5.75; 9.66 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02054325). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.