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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02054325
Recruitment Status : Completed
First Posted : February 4, 2014
Results First Posted : January 27, 2017
Last Update Posted : January 27, 2017
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Dr Matheus Bertanha, UPECLIN HC FM Botucatu Unesp

Tracking Information
First Submitted Date  ICMJE February 1, 2014
First Posted Date  ICMJE February 4, 2014
Results First Submitted Date  ICMJE December 22, 2014
Results First Posted Date  ICMJE January 27, 2017
Last Update Posted Date January 27, 2017
Study Start Date  ICMJE September 2012
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2016)
Efficacy in Treating Reticular Veins by Photographs: Mean Percent Reticular Vein Disappearance Two Months After Treatment. [ Time Frame: Mean Percent of 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 1, 2014)
Efficacy in treating reticular veins in the lower limbs [ Time Frame: The primary endpoint will be evaluated in two months ]
Photographs will be performed pretreatment and two months after the treatment, these will be analyzed for efficacy in treat reticular veins treated subjectively by two blind analyzers and objectively by another analyzer with measurement through the use of free software ImageJ
Change History Complete list of historical versions of study NCT02054325 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2016)
The Safety of the Treatment: Mean Percent of Skin Hyperpigmentation Two Months After Treatment [ Time Frame: Two months after treatment. ]
Skin hyperpigmentation was defined as a brownish hue stain superimposing the previous treated vein site (by visual photographic analyses). Skin hyperpigmentation was firstly evaluated according to its occurence and labeled as "Yes" or "No". Afterwards, when there was stain in the previous treated area, a line was drawn on the stain with Image J software , and the Mean Percent of Skin Hyperpigmentation was proportionaly compared with length of vein treated, previuos mesuread (mean and SD).
Original Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2014)
The safety of the treatment will be evaluated [ Time Frame: One week of treatment and two months of treatment. ]
Photographs will be performed pretreatment, a week after the treatment, and two months later. It will be performed clinical and photographic assessment of possible adverse effects.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Protocol Comparing Polidocanol Versus Hypertonic Glucose for Treatment of Reticular Veins
Official Title  ICMJE A Randomized Triple-blind Study Protocol Comparing Polidocanol Versus Hypertonic Glucose for Sclerotherapy in Treatment of Reticular Veins at the Lower Limbs.
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.
Detailed Description

Background. The prevalence of chronic venous disease is high in the general population, mainly in young women, and in milder cases the usual complaint is aesthetic. Various techniques are used for treatment of mild varicose disease, including surgical treatment, laser ablation and sclerotherapy. Reticular veins are those with less than 3mm diameter, bluish and important contribution to the aesthetic damage, and sometimes they are related to local pain and recurrence after treatment of telangiectasias. There is no consensus in the literature about the effectiveness of treatment with sclerotherapy, despite of being an usual procedure with different chemicals.

Methods and design. One hundred lower limbs of healthy women between 18 and 69 years will be triple blind randomized to receive treatment with polidocanol 0.2% diluted in 70% hypertonic glucose versus 75% hypertonic glucose for sclerotherapy treatment of reticular veins. The patients will be examined and clinically classified. It will be included patients with reticular veins sited at out's thigh/leg, measuring at least 10cm long, and only one extremity will be included per patient. The patients with varicose disease CEAP 2 or more will not be included. The treatment will be carried out in only one session and the medication volume not exceeding 5 ml. Clinical follow-up protocols will be filled on regular visits on days 0 - 7 - 60 concomitantly with photograph documentation. Supplementary examination for venous mapping with ultrasound pretreatment is performed for all patients.

Discussion. This prospective controlled double-blind randomized trial aims to verify and compare the efficacy and safety for sclerotherapy treatment of reticular veins of the lower limbs. The results may help physicians to choose the best sclerotherapy treatment for reticular veins.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Varicose Veins
Intervention  ICMJE
  • Drug: Polidocanol with Glucose
    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
    Other Names:
    • Dodecylpolyethyleneglycolether
    • Aethoxysklerol
    • Varithena
  • Drug: Glucose
    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
    Other Name: Dextrose
Study Arms  ICMJE
  • Active Comparator: Polidocanol with Glucose
    An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml.
    Intervention: Drug: Polidocanol with Glucose
  • Active Comparator: Glucose
    An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.
    Intervention: Drug: Glucose
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2016)
106
Original Estimated Enrollment  ICMJE
 (submitted: February 1, 2014)
100
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02054325
Other Study ID Numbers  ICMJE CEP 4127.2012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: We intend to present data when publish the original article.
Responsible Party Dr Matheus Bertanha, UPECLIN HC FM Botucatu Unesp
Study Sponsor  ICMJE UPECLIN HC FM Botucatu Unesp
Collaborators  ICMJE Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators  ICMJE
Principal Investigator: Matheus Bertanha, Professor UPECLIN HC FM Botucatu Unesp
PRS Account UPECLIN HC FM Botucatu Unesp
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP