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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polidocanol with Glucose | Active Comparator | An 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 Comparator | An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polidocanol with Glucose | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The Safety of the Treatment: Mean Percent of Skin Hyperpigmentation 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matheus Bertanha, Professor | UPECLIN HC FM Botucatu Unesp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Medicine at Botucatu- Paulista State University- UNESP, São Paulo, Brazil | Botucatu | São Paulo | 18607030 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28973414 | Derived | 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. | |
| 25527165 | Derived |
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We intend to present data when publish the original article.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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 |
| FG001 | Glucose | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | % of Reticular Veins that Disappeared | Mean Percent of reticular vein disappearance two months after treatment |
|
Right after two months post procedure
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)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperpigmentation | Skin and subcutaneous tissue disorders | DeCS http://decs.bvs | Systematic Assessment | Dark pigmentation of skin after injection |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Matheus Bertanha | UPECLIN | +55 14 38116305 | matheus.fameca@ig.com.br |
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| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077423 | Polidocanol |
| D005947 | Glucose |
| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
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|
| Glucose | Drug | 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 |
|
|
| Two months after treatment. |
| Bertanha 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. |
| BG001 | Glucose | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Gender | Count of Participants | Participants |
|
| OG001 | Glucose | 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 |
|
|
| Secondary | The Safety of the Treatment: Mean Percent of Skin Hyperpigmentation 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). | Posted | Mean | Standard Deviation | Percent of Skin Hyperpigmentation | Two months after treatment. |
|
|
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| 0 |
| 43 |
| 22 |
| 43 |
| EG001 | Glucose | 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 | 0 | 50 | 31 | 50 |
|
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| D009930 |
| Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |