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Double blind, randomized, placebo controlled clinical trial for the treatment of diabetic foot ulcers, using a nitric oxide releasing patch : PATHON

Background: Diabetes Mellitus constitutes one of the most important public health problems due to its high prevalence and enormous social and economic consequences. Diabetic foot ulcers are one of the chronic complications of diabetes mellitus and constitute the most important cause of non-trauma...

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Institution:Universidad EIA
Main Authors: Silva, Sandra Y., Rueda, Ligia C., Márquez, Gustavo, López Casillas, Marcos, Smith, Daniel J., Calderón, Carlos A., Castillo, Juan C., Matute, Jaime, Rueda Clausen, Christian F., Orduz, Arturo, Silva Sieger, Federico Arturo, Kampeerapappun, Piyaporn, Bhide, Mahesh, Lopez-Jaramillo, Patricio
Format: Artículo de revista
Language:English
Published: 2007-09-26
Subjects:
Placebo controlled
Diabetic foot ulcers
Online Access:https://repositorio.udes.edu.co/handle/001/3294
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id oai:null:001-3294
recordtype dspace
spelling Silva, Sandra Y.
Rueda, Ligia C.
Márquez, Gustavo
López Casillas, Marcos
Smith, Daniel J.
Calderón, Carlos A.
Castillo, Juan C.
Matute, Jaime
Rueda Clausen, Christian F.
Orduz, Arturo
Silva Sieger, Federico Arturo
Kampeerapappun, Piyaporn
Bhide, Mahesh
Lopez-Jaramillo, Patricio
2019-07-08T13:21:10Z
2019-07-08T13:21:10Z
2007-09-26
8 p.
Background: Diabetes Mellitus constitutes one of the most important public health problems due to its high prevalence and enormous social and economic consequences. Diabetic foot ulcers are one of the chronic complications of diabetes mellitus and constitute the most important cause of non-traumatic amputation of inferior limbs. It is estimated that 15% of the diabetic population will develop an ulcer sometime in their lives. Although novel therapies have been proposed, there is no effective treatment for this pathology. Naturally produced nitric oxide participates in the wound healing process by stimulating the synthesis of collagen, triggering the release of chemotactic cytokines, increasing blood vessels permeability, promoting angiogenic activity, stimulating the release of epidermical growth factors, and by interfering with the bacterial mitochondrial respiratory chain. Topically administered nitric oxide has demonstrated to be effective and safe for the treatment of chronic ulcers secondary to cutaneous leishmaniasis. However, due to their unstable nitric oxide release, the topical donors needed to be applied frequently, diminishing the adherence to the treatment. This difficulty has led to the development of a multilayer polymeric transdermal patch produced by electrospinning technique that guarantees a constant nitric oxide release. The main objective of this study is to evaluate the effectiveness and safety of this novel nitric oxide releasing wound dressing for the treatment of diabetic foot ulcers. Methods and design: A double-blind, placebo-controlled clinical trial, including 100 diabetic patients was designed. At the time of enrollment, a complete medical evaluation and laboratory tests will be performed, and those patients who meet the inclusion criteria randomly assigned to one of two groups. Over the course of 90 days group 1 will receive active patches and group 2 placebo patches. The patients will be seen by the research group at least every two weeks until the healing of the ulcer or the end of the treatment. During each visit the healing process of the ulcer, the patient's health status and the presence of adverse events will be assessed. Should the effectiveness of the patches be demonstrated an alternative treatment would then be available to patients.
application/pdf
10.1186/1745-6215-8-26
1745-6215
https://repositorio.udes.edu.co/handle/001/3294
eng
Trials
Derechos Reservados - Trials, 2007
info:eu-repo/semantics/openAccess
Atribución-NoComercial 4.0 Internacional (CC BY-NC 4.0)
https://creativecommons.org/licenses/by-nc/4.0/
https://trialsjournal.biomedcentral.com/track/pdf/10.1186/1745-6215-8-26
Placebo controlled
Diabetic foot ulcers
Double blind, randomized, placebo controlled clinical trial for the treatment of diabetic foot ulcers, using a nitric oxide releasing patch : PATHON
Artículo de revista
http://purl.org/coar/resource_type/c_6501
Text
info:eu-repo/semantics/article
http://purl.org/redcol/resource_type/ART
info:eu-repo/semantics/publishedVersion
Publication
http://purl.org/coar/access_right/c_abf2
http://purl.org/coar/version/c_970fb48d4fbd8a85
institution Universidad EIA
collection d_repositorio.udes.edu.co-DSPACE
title Double blind, randomized, placebo controlled clinical trial for the treatment of diabetic foot ulcers, using a nitric oxide releasing patch : PATHON
spellingShingle Double blind, randomized, placebo controlled clinical trial for the treatment of diabetic foot ulcers, using a nitric oxide releasing patch : PATHON
Silva, Sandra Y.
Rueda, Ligia C.
Márquez, Gustavo
López Casillas, Marcos
Smith, Daniel J.
Calderón, Carlos A.
Castillo, Juan C.
Matute, Jaime
Rueda Clausen, Christian F.
Orduz, Arturo
Silva Sieger, Federico Arturo
Kampeerapappun, Piyaporn
Bhide, Mahesh
Lopez-Jaramillo, Patricio
Silva, Sandra Y.
Rueda, Ligia C.
Márquez, Gustavo
López Casillas, Marcos
Smith, Daniel J.
Calderón, Carlos A.
Castillo, Juan C.
Matute, Jaime
Rueda Clausen, Christian F.
Orduz, Arturo
Silva Sieger, Federico Arturo
Kampeerapappun, Piyaporn
Bhide, Mahesh
Lopez-Jaramillo, Patricio
Placebo controlled
Diabetic foot ulcers
title_short Double blind, randomized, placebo controlled clinical trial for the treatment of diabetic foot ulcers, using a nitric oxide releasing patch : PATHON
title_full Double blind, randomized, placebo controlled clinical trial for the treatment of diabetic foot ulcers, using a nitric oxide releasing patch : PATHON
title_fullStr Double blind, randomized, placebo controlled clinical trial for the treatment of diabetic foot ulcers, using a nitric oxide releasing patch : PATHON
title_full_unstemmed Double blind, randomized, placebo controlled clinical trial for the treatment of diabetic foot ulcers, using a nitric oxide releasing patch : PATHON
title_sort double blind, randomized, placebo controlled clinical trial for the treatment of diabetic foot ulcers, using a nitric oxide releasing patch : pathon
author Silva, Sandra Y.
Rueda, Ligia C.
Márquez, Gustavo
López Casillas, Marcos
Smith, Daniel J.
Calderón, Carlos A.
Castillo, Juan C.
Matute, Jaime
Rueda Clausen, Christian F.
Orduz, Arturo
Silva Sieger, Federico Arturo
Kampeerapappun, Piyaporn
Bhide, Mahesh
Lopez-Jaramillo, Patricio
Silva, Sandra Y.
Rueda, Ligia C.
Márquez, Gustavo
López Casillas, Marcos
Smith, Daniel J.
Calderón, Carlos A.
Castillo, Juan C.
Matute, Jaime
Rueda Clausen, Christian F.
Orduz, Arturo
Silva Sieger, Federico Arturo
Kampeerapappun, Piyaporn
Bhide, Mahesh
Lopez-Jaramillo, Patricio
author_facet Silva, Sandra Y.
Rueda, Ligia C.
Márquez, Gustavo
López Casillas, Marcos
Smith, Daniel J.
Calderón, Carlos A.
Castillo, Juan C.
Matute, Jaime
Rueda Clausen, Christian F.
Orduz, Arturo
Silva Sieger, Federico Arturo
Kampeerapappun, Piyaporn
Bhide, Mahesh
Lopez-Jaramillo, Patricio
Silva, Sandra Y.
Rueda, Ligia C.
Márquez, Gustavo
López Casillas, Marcos
Smith, Daniel J.
Calderón, Carlos A.
Castillo, Juan C.
Matute, Jaime
Rueda Clausen, Christian F.
Orduz, Arturo
Silva Sieger, Federico Arturo
Kampeerapappun, Piyaporn
Bhide, Mahesh
Lopez-Jaramillo, Patricio
building Repositorio digital
topic Placebo controlled
Diabetic foot ulcers
topic_facet Placebo controlled
Diabetic foot ulcers
publishDate 2007-09-26
language English
format Artículo de revista
description Background: Diabetes Mellitus constitutes one of the most important public health problems due to its high prevalence and enormous social and economic consequences. Diabetic foot ulcers are one of the chronic complications of diabetes mellitus and constitute the most important cause of non-traumatic amputation of inferior limbs. It is estimated that 15% of the diabetic population will develop an ulcer sometime in their lives. Although novel therapies have been proposed, there is no effective treatment for this pathology. Naturally produced nitric oxide participates in the wound healing process by stimulating the synthesis of collagen, triggering the release of chemotactic cytokines, increasing blood vessels permeability, promoting angiogenic activity, stimulating the release of epidermical growth factors, and by interfering with the bacterial mitochondrial respiratory chain. Topically administered nitric oxide has demonstrated to be effective and safe for the treatment of chronic ulcers secondary to cutaneous leishmaniasis. However, due to their unstable nitric oxide release, the topical donors needed to be applied frequently, diminishing the adherence to the treatment. This difficulty has led to the development of a multilayer polymeric transdermal patch produced by electrospinning technique that guarantees a constant nitric oxide release. The main objective of this study is to evaluate the effectiveness and safety of this novel nitric oxide releasing wound dressing for the treatment of diabetic foot ulcers. Methods and design: A double-blind, placebo-controlled clinical trial, including 100 diabetic patients was designed. At the time of enrollment, a complete medical evaluation and laboratory tests will be performed, and those patients who meet the inclusion criteria randomly assigned to one of two groups. Over the course of 90 days group 1 will receive active patches and group 2 placebo patches. The patients will be seen by the research group at least every two weeks until the healing of the ulcer or the end of the treatment. During each visit the healing process of the ulcer, the patient's health status and the presence of adverse events will be assessed. Should the effectiveness of the patches be demonstrated an alternative treatment would then be available to patients.
issn 1745-6215
url https://repositorio.udes.edu.co/handle/001/3294
url_str_mv https://repositorio.udes.edu.co/handle/001/3294
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score 11.346045