Polidocanol versus glucose in the treatment of telangiectasia of the lower limbs (PG3T) Protocol for a randomized, controlled clinical trial

Detalhes bibliográficos
Autor(a) principal: Bertanha, Matheus [UNESP]
Data de Publicação: 2016
Outros Autores: De Camargo, Paula Angeleli Bueno [UNESP], Moura, Regina [UNESP], Yoshida, Winston Bonetti [UNESP], Farres Pimenta, Rafael Elias [UNESP], De Oliveira Mariuba, Jamil Victor [UNESP], Alcantara, Giovana Piteri [UNESP], De Paula, Dênia Reis [UNESP], Sobreira, Marcone Lima [UNESP]
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da UNESP
Texto Completo: http://dx.doi.org/10.1097/MD.0000000000004812
http://hdl.handle.net/11449/174272
Resumo: Background: Telangiectasias are defined as small venules abnormally dilated, located in the intradermal portion of the skin, of reddish or bluish tinge, their diameter not exceeding 1mm; they are classified by the American Venous Forum as mild venous disease CEAP C1. Conventional treatment consists of chemical sclerotherapy, considered a minimally invasive technique with rapid clinical recovery. A wide variety of sclerosing solutions can be used for this purpose. Methods/design: This project intends to include 96 patients that will be randomized to a triple-blind study. Inclusion criteria are women between 18 and 65 years, with telangiectasia on the lateral thigh. Male patients, female patients with chronic venous disease CEAP 2 to 6, women with allergies, pregnant, breastfeeding, with any type of skin problems or any decompensated clinical disease will be excluded. All patients included will be submitted to venous ultrasound mapping in order to rule out venous disease not clinically visible, deep venous system insufficiency, and insufficiency of the ostial valve of the great saphenous vein. One group will be treated with glucose 75% solution and the other will receive polidocanol 0.2% diluted in glucose 70%. Each patient will receive only 1 treatment session in 1 single member. The volume of sclerosing solution will not exceed 5mL and the treatment area will be limited to a region of 150cm2 on the lateral thigh. Clinical follow-up will be: 1 initial visit, when the clinical report will be filled; photographic record and treatment with sclerotherapy (D0); follow-up visits after 7 and 60 days (D7 and D60, respectively), always with clinical and photographic documentation. Discussion: The project intends to evaluate the efficacy and safety of sclerotherapy in eliminating telangiectasia in a predetermined area in order to establish efficacy and safety parameters for the treatments presented. Conclusion: This protocol for clinical trial will provide date to determine the efficacy and safety of sclerotherapy with the solutions presented. Trial registration identifier: ClinicalTrial.gov NCT02657252 Date: 01/12/2016 (retrospectively registered).
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spelling Polidocanol versus glucose in the treatment of telangiectasia of the lower limbs (PG3T) Protocol for a randomized, controlled clinical trialGlucose solutionHypertonicSclerosing solutionsSclerotherapySpider veinsTelangiectasisVaricose veinsVeinsBackground: Telangiectasias are defined as small venules abnormally dilated, located in the intradermal portion of the skin, of reddish or bluish tinge, their diameter not exceeding 1mm; they are classified by the American Venous Forum as mild venous disease CEAP C1. Conventional treatment consists of chemical sclerotherapy, considered a minimally invasive technique with rapid clinical recovery. A wide variety of sclerosing solutions can be used for this purpose. Methods/design: This project intends to include 96 patients that will be randomized to a triple-blind study. Inclusion criteria are women between 18 and 65 years, with telangiectasia on the lateral thigh. Male patients, female patients with chronic venous disease CEAP 2 to 6, women with allergies, pregnant, breastfeeding, with any type of skin problems or any decompensated clinical disease will be excluded. All patients included will be submitted to venous ultrasound mapping in order to rule out venous disease not clinically visible, deep venous system insufficiency, and insufficiency of the ostial valve of the great saphenous vein. One group will be treated with glucose 75% solution and the other will receive polidocanol 0.2% diluted in glucose 70%. Each patient will receive only 1 treatment session in 1 single member. The volume of sclerosing solution will not exceed 5mL and the treatment area will be limited to a region of 150cm2 on the lateral thigh. Clinical follow-up will be: 1 initial visit, when the clinical report will be filled; photographic record and treatment with sclerotherapy (D0); follow-up visits after 7 and 60 days (D7 and D60, respectively), always with clinical and photographic documentation. Discussion: The project intends to evaluate the efficacy and safety of sclerotherapy in eliminating telangiectasia in a predetermined area in order to establish efficacy and safety parameters for the treatments presented. Conclusion: This protocol for clinical trial will provide date to determine the efficacy and safety of sclerotherapy with the solutions presented. Trial registration identifier: ClinicalTrial.gov NCT02657252 Date: 01/12/2016 (retrospectively registered).Discipline of Angiology and Vascular of Departament of Surgery and Orthopedics Botucatu Medical School UNESP, Av. Prof. Mario Rubens Guimaraes Montenegro, s/nBotucatu Medical School UNESPDiscipline of Angiology and Vascular of Departament of Surgery and Orthopedics Botucatu Medical School UNESP, Av. Prof. Mario Rubens Guimaraes Montenegro, s/nBotucatu Medical School UNESPUniversidade Estadual Paulista (Unesp)Bertanha, Matheus [UNESP]De Camargo, Paula Angeleli Bueno [UNESP]Moura, Regina [UNESP]Yoshida, Winston Bonetti [UNESP]Farres Pimenta, Rafael Elias [UNESP]De Oliveira Mariuba, Jamil Victor [UNESP]Alcantara, Giovana Piteri [UNESP]De Paula, Dênia Reis [UNESP]Sobreira, Marcone Lima [UNESP]2018-12-11T17:10:07Z2018-12-11T17:10:07Z2016-01-01info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://dx.doi.org/10.1097/MD.0000000000004812Medicine (United States), v. 95, n. 39, 2016.1536-59640025-7974http://hdl.handle.net/11449/17427210.1097/MD.00000000000048122-s2.0-850138166702-s2.0-85013816670.pdf96093248325913824513014379461383Scopusreponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengMedicine (United States)0,799info:eu-repo/semantics/openAccess2024-08-14T14:18:17Zoai:repositorio.unesp.br:11449/174272Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462024-08-14T14:18:17Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false
dc.title.none.fl_str_mv Polidocanol versus glucose in the treatment of telangiectasia of the lower limbs (PG3T) Protocol for a randomized, controlled clinical trial
title Polidocanol versus glucose in the treatment of telangiectasia of the lower limbs (PG3T) Protocol for a randomized, controlled clinical trial
spellingShingle Polidocanol versus glucose in the treatment of telangiectasia of the lower limbs (PG3T) Protocol for a randomized, controlled clinical trial
Bertanha, Matheus [UNESP]
Glucose solution
Hypertonic
Sclerosing solutions
Sclerotherapy
Spider veins
Telangiectasis
Varicose veins
Veins
title_short Polidocanol versus glucose in the treatment of telangiectasia of the lower limbs (PG3T) Protocol for a randomized, controlled clinical trial
title_full Polidocanol versus glucose in the treatment of telangiectasia of the lower limbs (PG3T) Protocol for a randomized, controlled clinical trial
title_fullStr Polidocanol versus glucose in the treatment of telangiectasia of the lower limbs (PG3T) Protocol for a randomized, controlled clinical trial
title_full_unstemmed Polidocanol versus glucose in the treatment of telangiectasia of the lower limbs (PG3T) Protocol for a randomized, controlled clinical trial
title_sort Polidocanol versus glucose in the treatment of telangiectasia of the lower limbs (PG3T) Protocol for a randomized, controlled clinical trial
author Bertanha, Matheus [UNESP]
author_facet Bertanha, Matheus [UNESP]
De Camargo, Paula Angeleli Bueno [UNESP]
Moura, Regina [UNESP]
Yoshida, Winston Bonetti [UNESP]
Farres Pimenta, Rafael Elias [UNESP]
De Oliveira Mariuba, Jamil Victor [UNESP]
Alcantara, Giovana Piteri [UNESP]
De Paula, Dênia Reis [UNESP]
Sobreira, Marcone Lima [UNESP]
author_role author
author2 De Camargo, Paula Angeleli Bueno [UNESP]
Moura, Regina [UNESP]
Yoshida, Winston Bonetti [UNESP]
Farres Pimenta, Rafael Elias [UNESP]
De Oliveira Mariuba, Jamil Victor [UNESP]
Alcantara, Giovana Piteri [UNESP]
De Paula, Dênia Reis [UNESP]
Sobreira, Marcone Lima [UNESP]
author2_role author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Universidade Estadual Paulista (Unesp)
dc.contributor.author.fl_str_mv Bertanha, Matheus [UNESP]
De Camargo, Paula Angeleli Bueno [UNESP]
Moura, Regina [UNESP]
Yoshida, Winston Bonetti [UNESP]
Farres Pimenta, Rafael Elias [UNESP]
De Oliveira Mariuba, Jamil Victor [UNESP]
Alcantara, Giovana Piteri [UNESP]
De Paula, Dênia Reis [UNESP]
Sobreira, Marcone Lima [UNESP]
dc.subject.por.fl_str_mv Glucose solution
Hypertonic
Sclerosing solutions
Sclerotherapy
Spider veins
Telangiectasis
Varicose veins
Veins
topic Glucose solution
Hypertonic
Sclerosing solutions
Sclerotherapy
Spider veins
Telangiectasis
Varicose veins
Veins
description Background: Telangiectasias are defined as small venules abnormally dilated, located in the intradermal portion of the skin, of reddish or bluish tinge, their diameter not exceeding 1mm; they are classified by the American Venous Forum as mild venous disease CEAP C1. Conventional treatment consists of chemical sclerotherapy, considered a minimally invasive technique with rapid clinical recovery. A wide variety of sclerosing solutions can be used for this purpose. Methods/design: This project intends to include 96 patients that will be randomized to a triple-blind study. Inclusion criteria are women between 18 and 65 years, with telangiectasia on the lateral thigh. Male patients, female patients with chronic venous disease CEAP 2 to 6, women with allergies, pregnant, breastfeeding, with any type of skin problems or any decompensated clinical disease will be excluded. All patients included will be submitted to venous ultrasound mapping in order to rule out venous disease not clinically visible, deep venous system insufficiency, and insufficiency of the ostial valve of the great saphenous vein. One group will be treated with glucose 75% solution and the other will receive polidocanol 0.2% diluted in glucose 70%. Each patient will receive only 1 treatment session in 1 single member. The volume of sclerosing solution will not exceed 5mL and the treatment area will be limited to a region of 150cm2 on the lateral thigh. Clinical follow-up will be: 1 initial visit, when the clinical report will be filled; photographic record and treatment with sclerotherapy (D0); follow-up visits after 7 and 60 days (D7 and D60, respectively), always with clinical and photographic documentation. Discussion: The project intends to evaluate the efficacy and safety of sclerotherapy in eliminating telangiectasia in a predetermined area in order to establish efficacy and safety parameters for the treatments presented. Conclusion: This protocol for clinical trial will provide date to determine the efficacy and safety of sclerotherapy with the solutions presented. Trial registration identifier: ClinicalTrial.gov NCT02657252 Date: 01/12/2016 (retrospectively registered).
publishDate 2016
dc.date.none.fl_str_mv 2016-01-01
2018-12-11T17:10:07Z
2018-12-11T17:10:07Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://dx.doi.org/10.1097/MD.0000000000004812
Medicine (United States), v. 95, n. 39, 2016.
1536-5964
0025-7974
http://hdl.handle.net/11449/174272
10.1097/MD.0000000000004812
2-s2.0-85013816670
2-s2.0-85013816670.pdf
9609324832591382
4513014379461383
url http://dx.doi.org/10.1097/MD.0000000000004812
http://hdl.handle.net/11449/174272
identifier_str_mv Medicine (United States), v. 95, n. 39, 2016.
1536-5964
0025-7974
10.1097/MD.0000000000004812
2-s2.0-85013816670
2-s2.0-85013816670.pdf
9609324832591382
4513014379461383
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv Medicine (United States)
0,799
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv Scopus
reponame:Repositório Institucional da UNESP
instname:Universidade Estadual Paulista (UNESP)
instacron:UNESP
instname_str Universidade Estadual Paulista (UNESP)
instacron_str UNESP
institution UNESP
reponame_str Repositório Institucional da UNESP
collection Repositório Institucional da UNESP
repository.name.fl_str_mv Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)
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