Phase 4
N=115
Polidocanol Versus Glucose Treatment of Telangiectasia Trial
Varicose Veins · Telangiectasis
Bottom Line
View on ClinicalTrials.gov: NCT02657252 ↗Enrolled (actual)
115
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcome: Primary: Change From Baseline in Extent of Telangiectasias — 57.24; 76.08 percent of change negative values
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Glucose (Drug); Polidocanol with Glucose (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- UPECLIN HC FM Botucatu Unesp
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Extent of Telangiectasias |
57.24; 76.08 | — |
| SECONDARY Skin Hyperpigmentation |
0.49; 0 | — |
| SECONDARY Number of Participants With Deep Venous Thrombosis (DVT) |
0; 0 | — |
Summary
It will be done a randomized triple-blind study comparing 0,2% polidocanol versus 75% hypertonic glucose of sclerotherapy in lower limbs´ telangiectasis. 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 telangiectasis on thigh side
- clinical classification of chronic venous disease C1(mild venous disease),
- minimum age of 18 year-old and maximum age 65 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
- don´t be 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 (NCT02657252). 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.