Study Protocol Comparing Polidocanol Versus Hypertonic Glucose for Treatment of Reticular Veins
A Randomized Triple-blind Study Protocol Comparing Polidocanol Versus Hypertonic Glucose for Sclerotherapy in Treatment of Reticular Veins at the Lower Limbs.
1 other identifier
interventional
106
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2012
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 1, 2014
CompletedFirst Posted
Study publicly available on registry
February 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
January 27, 2017
CompletedJanuary 27, 2017
November 1, 2016
2.2 years
February 1, 2014
December 22, 2014
November 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy in Treating Reticular Veins by Photographs: Mean Percent Reticular Vein Disappearance Two Months After Treatment.
Photographs were performed pretreatment and two months after the treatment, these were analyzed for efficacy in treat reticular veins by two blind analyzers objectively with measurement through the use of free software ImageJ.
Mean Percent of reticular vein disappearance two months after treatment
Secondary Outcomes (1)
The Safety of the Treatment: Mean Percent of Skin Hyperpigmentation Two Months After Treatment
Two months after treatment.
Study Arms (2)
Polidocanol with Glucose
ACTIVE COMPARATORAn application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml.
Glucose
ACTIVE COMPARATORAn application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.
Interventions
An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects
An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects
Eligibility Criteria
You may qualify if:
- 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 .
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School of Medicine at Botucatu- Paulista State University- UNESP, São Paulo, Brazil
Botucatu, São Paulo, 18607030, Brazil
Related Publications (2)
Bertanha M, Jaldin RG, Moura R, Pimenta REF, Mariuba JVO, Lucio Filho CEP, Alcantara GP, Padovani CR, Yoshida WB, Sobreira ML. Sclerotherapy for Reticular Veins in the Lower Limbs: A Triple-Blind Randomized Clinical Trial. JAMA Dermatol. 2017 Dec 1;153(12):1249-1255. doi: 10.1001/jamadermatol.2017.3426.
PMID: 28973414DERIVEDBertanha M, Sobreira ML, Pinheiro Lucio Filho CE, de Oliveira Mariuba JV, Farres Pimenta RE, Jaldin RG, Moroz A, Moura R, Rollo HA, Yoshida WB. Polidocanol versus hypertonic glucose for sclerotherapy treatment of reticular veins of the lower limbs: study protocol for a randomized controlled trial. Trials. 2014 Dec 19;15:497. doi: 10.1186/1745-6215-15-497.
PMID: 25527165DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Matheus Bertanha
- Organization
- UPECLIN
Study Officials
- PRINCIPAL INVESTIGATOR
Matheus Bertanha, Professor
UPECLIN HC FM Botucatu Unesp
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 1, 2014
First Posted
February 4, 2014
Study Start
September 1, 2012
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
January 27, 2017
Results First Posted
January 27, 2017
Record last verified: 2016-11