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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Varicose Veins
Interventions Drug: Polidocanol with Glucose
Drug: Glucose
Enrollment 106
Recruitment Details  
Pre-assignment Details Some patients (n=6) were withdrawn because did not appear at the previous scheduled appointments, and were replaced for new ones. In order to avoid loss of individuals we have decided to include 6 more patients.
Arm/Group Title Polidocanol With Glucose Glucose
Hide Arm/Group Description

An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml.

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

An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.

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

Period Title: Overall Study
Started 51 55
Completed 43 50
Not Completed 8 5
Reason Not Completed
Lost to Follow-up             8             5
Arm/Group Title Polidocanol With Glucose Glucose Total
Hide Arm/Group Description

An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml.

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

An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.

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

Total of all reporting groups
Overall Number of Baseline Participants 43 50 93
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 50 participants 93 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
43
 100.0%
50
 100.0%
93
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 50 participants 93 participants
Female
43
 100.0%
50
 100.0%
93
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Efficacy in Treating Reticular Veins by Photographs: Mean Percent Reticular Vein Disappearance Two Months After Treatment.
Hide Description 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.
Time Frame Mean Percent of reticular vein disappearance two months after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Polidocanol With Glucose Glucose
Hide Arm/Group Description:

An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml.

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

An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.

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

Overall Number of Participants Analyzed 43 50
Mean (Standard Deviation)
Unit of Measure: % of Reticular Veins that Disappeared
95.17  (9.09) 85.40  (17.04)
2.Secondary Outcome
Title The Safety of the Treatment: Mean Percent of Skin Hyperpigmentation Two Months After Treatment
Hide Description 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).
Time Frame Two months after treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Polidocanol With Glucose Glucose
Hide Arm/Group Description:

An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml.

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

An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.

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

Overall Number of Participants Analyzed 43 50
Mean (Standard Deviation)
Unit of Measure: Percent of Skin Hyperpigmentation
5.75  (7.02) 9.66  (11.67)
Time Frame Right after two months post procedure
Adverse Event Reporting Description Hyperpigmentation: Linear measure above the projection area of hyperpigmentation post procedure. The length of this line was provided by the Image J software (ImageJ is a public domain, Java-based image processing program developed at the National Institutes of Health)
 
Arm/Group Title Polidocanol With Glucose Glucose
Hide Arm/Group Description

An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml.

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

An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.

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

All-Cause Mortality
Polidocanol With Glucose Glucose
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Polidocanol With Glucose Glucose
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/50 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Polidocanol With Glucose Glucose
Affected / at Risk (%) Affected / at Risk (%)
Total   22/43 (51.16%)   31/50 (62.00%) 
Skin and subcutaneous tissue disorders     
Hyperpigmentation  1 [1]  22/43 (51.16%)  31/50 (62.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, DeCS http://decs.bvs
[1]
Dark pigmentation of skin after injection
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Matheus Bertanha
Organization: UPECLIN
Phone: +55 14 38116305
EMail: matheus.fameca@ig.com.br
Layout table for additonal information
Responsible Party: Dr Matheus Bertanha, UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier: NCT02054325    
Other Study ID Numbers: CEP 4127.2012
First Submitted: February 1, 2014
First Posted: February 4, 2014
Results First Submitted: December 22, 2014
Results First Posted: January 27, 2017
Last Update Posted: January 27, 2017