Document Detail


Intra-lesional injections of recombinant human epidermal growth factor promote granulation and healing in advanced diabetic foot ulcers: multicenter, randomised, placebo-controlled, double-blind study.
MedLine Citation:
PMID:  20051095     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
A multicenter, double-blind, placebo-controlled trial was carried out to evaluate the intra-lesional infiltration of recombinant epidermal growth factor (EGF) in Wagner's grade 3 or 4 diabetic foot ulcers (DFUs). Subjects (149) were randomised to receive EGF (75 or 25 microg) or placebo, three times per week for 8 weeks and standard good wound care. The main endpoint was granulation tissue covering > or = 50% of the ulcer at 2 weeks. It was achieved by 19/48 controls versus 44/53 in the 75 microg group [odds ratio (OR): 7.5; 95% confidence interval (CI): 2.9-18.9] and 34/48 in the 25 microg group (OR: 3.7; 1.6-8.7). Secondary outcome variables such as end-of-treatment complete granulation response (28/48 controls, 46/53 with 75 microg and 34/48 with 25 microg EGF), time-to-complete response (controls: 5 weeks; both EGF dose groups: 3 weeks), and wound closure after follow-up (25/48 controls, 40/53 with 75 microg and 25/48 with 25 microg EGF) were also treatment dependent. Multivariate analyses yielded that they were significantly enhanced by 75 microg EGF treatment and neuropathic versus ischemic ulcers. Most adverse events were mild and no drug-related severe adverse reactions were reported. It was concluded that recombinant human EGF (rhEGF) local injections offer a favourable risk-benefit balance in patients with advanced DFU.
Authors:
Jos? I Fern?ndez-Montequ?n; Carmen M Valenzuela-Silva; Odalys Gonz?lez D?az; William Savigne; Natasha Sancho-Soutelo; Fidel Rivero-Fern?ndez; Pablo S?nchez-Penton; Lourdes Morej?n-Vega; Heriberto Artaza-Sanz; Ar?stides Garc?a-Herrera; Cecilio Gonz?lez-Benavides; Carlos M Hern?ndez-Ca?ete; Alberto V?zquez-Proenza; Jorge Berlanga-Acosta; Pedro A L?pez-Saura;
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  International wound journal     Volume:  6     ISSN:  1742-481X     ISO Abbreviation:  Int Wound J     Publication Date:  2009 Dec 
Date Detail:
Created Date:  2010-01-06     Completed Date:  2010-03-18     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101230907     Medline TA:  Int Wound J     Country:  England    
Other Details:
Languages:  eng     Pagination:  432-43     Citation Subset:  IM    
Affiliation:
JI Fern?ndez-Montequ?n, MD, National Institute for Angiology and Vascular Surgery, Havana, Cuba.
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MeSH Terms
Descriptor/Qualifier:
Aged
Diabetic Foot / drug therapy*,  pathology
Dose-Response Relationship, Drug
Double-Blind Method
Epidermal Growth Factor / administration & dosage*
Female
Follow-Up Studies
Granulation Tissue / drug effects*,  pathology
Humans
Injections, Intralesional
Male
Middle Aged
Recombinant Proteins / administration & dosage*
Treatment Outcome
Wound Healing / drug effects*
Chemical
Reg. No./Substance:
0/Recombinant Proteins; 62229-50-9/Epidermal Growth Factor
Investigator
Investigator/Affiliation:
Jos? Fern?ndez-Montequin / ; Neobalis Franco-Vega / ; William O Savigne-Guti?rrez / ; Calixto Vald?s-P?rez / ; Nelson Chirino-Carre?o / ; H?ctor T Alvarez-Duarte / ; Agust?n Llanes / ; Alfredo Aldama-Figueroa / ; Daniel Reynaldo / ; Milagros Garcia / ; Jos? G Hern?ndez / ; Maria E Triana-Mantilla / ; Martha Gonz?lez Gonz?lez / ; Mireya Alonso-Rios / ; Olga Morejon-Reinoso / ; Julia Zapata-Vinent / ; Ines Pilar Gonzalez / ; Martina Garcia-Insua / ; Dulce M Armenteros-Herrera / ; Alicia Rodriguez-Perez / ; Amada A Fernandez Fernandez-Bolo?a / ; Laureano Pe?a-Bazart / ; Ana L Hernandez-Rojas / ; Antonio J D?az-D?az / ; Marta M Moreira-Martinez / ; Aid? Hern?ndez-Hern?ndez / ; Odalys Rivera-Martinez / ; Martha L Guti?rrez-Guti?rrez / ; Yudexy Martinez-Pino / ; Martha Hernandez-Miranda / ; Ilsa Dopico-Reyes / ; Marlen Millar-Rojas / ; Georgina Greaves-Turro / ; Arturo P?rez-Chamber / ; Alina Carri?-Berenguer / ; Orqu?dea Rodr?guez-Imbert / ; Angel Cuza-Rodr?guez / ; Sandra Ferrer-Fern?ndez / ; Mylen Correa-Colom? / ; Nielbis Fr?meta-Rodr?guez / ; Yadileidi El?as-Oquendo / ; Natacha Sancho-Soutelo / ; Sergio Alvarez-Gonz?lez / ; Yirsa Luna-Negret / ; Sandra Dura?ones-G??ngora / ; Mercedes Guilart-P?rez / ; Martha Fern?ndez-Hechevarria / ; Mirta Dom?nguez-Salgueras / ; Ledis Garbey-Delas / ; Vivian Soto-Infante / ; Maria Elena Pardo-Portuondo / ; Fidel Rivero-Fern?ndez / ; Ariel Hern?ndez-Varela / ; Jorge L Vald?s-N?poles / ; Odalys Escalante-Padr?n / ; V?ctor Alfonso-Lanz / ; Nicol?s Socarr?s-Olivera / ; Melsa V?zquez-Miranda / ; Idal?n Conde-Guerra / ; Daliana Somonte-S?nchez / ; Tom?s Jim?nez-Leyva / ; Yaneydis Lores-M?ndez / ; Judith Ojeda-de Pedro / ; Pablo S?nchez-Penton / ; Ana L Tabio-Reyes / ; Irelio Borroto-Carpio / ; Diosnelkis Vera-Candelario / ; Deisy Pi?a-L?pez / ; Maria de La C Hern?ndez-Morgado / ; Carmen Landa-Quintero / ; Marielis Hern?ndez-Oria / ; Martha E Armas-Rivadeneira / ; Belquis Herrera-Lopez / ; Nancy Machin-Gonz?lez / ; Herminia Rodriguez-Cata?eda / ; Lourdes Morej?n-Vega / ; Edgar George-Laffita / ; Luis Mayor-Gonz?lez / ; Alberto Valerio-Mendiondo / ; Luis Thaureaux-Montes de Oca / ; Raquel Ram?n-Brizuela / ; Maximo Sandez-L?pez / ; Miladys Rodr?guez-Caballero / ; Wilfredo Su?rez-del Castillo / ; Liana Padr?n-Men?ndez / ; Jos? L Alonso-Gonz??lez / ; Dulce Garcia-Esplugas / ; Aida Lopez / ; Rosa Diaz / ; Heriberto Artaza-Sanz / ; Pedro Goicochea-Diaz / ; Angela Blanco-D?az / ; Natalia Pool-Marr?n / ; Dinorah Gonz?lez-Vi?ales / ; Evaristo Vargas-Machiran / ; Eduardo Atencio-Sariol / ; Alexis Janero-Vald?s / ; Marta P??rez-Linares / ; Cherezada Vidal-Ram??rez / ; Teresa Alvarez-Padr?n / ; Delfina Costales-Elizarde / ; Gerardo Maza / ; Ar?stides Garc?a-Herrera / ; Edel Fleitas-Prez / ; Ra?l Rodrguez-Fern?ndez / ; Vania Maria Pe?a-Ruiz / ; Ridel Febles-Sanabria / ; Zoraida G??mez-Sotolongo / ; Ana Gloria Alfonso-Le?n / ; Rosa Medina-Quesada / ; Pedro Castillo-Herrera / ; Vivian Ramos-Rguez / ; Andr?s Lamas-Acevedo / ; Dayam? Montes de Oca-Fern?ndez / ; Frank Aguirre-Rdguez / ; Cecilio Gonz?lez-Benavides / ; Teresita Feito-Costex / ; Juan M Garc?a-Vel?squez / ; Felicia Garc?a-Seco / ; Amel Alfonso-Sim?n / ; Yasmin Rodr?guez-R?os / ; Omar Hern?ndez-Gonz?lez / ; Magalys de la Barca-Barrera / ; Ileana Wong-Romero / ; Manuel Cruz-Sosa / ; Yaritsy Abreu-G?mez / ; Galia Averhoff / ; Maria Margarita R?os-Cabrera / ; Jose R Ferra-Gonzalez / ; Ivonne Marrero-Rodr?guez / ; Javier de J Borrego-Acosta / ; Nancy Ram?rez-Mart?nez / ; Belkis Cala?a-Gonz?lez-Posada / ; Ivette Garc?a-A lvarez / ; Yadira Gonzalez-Su?rez / ; Dayam? Villaveir?n-Fern?ndez / ; Yanet Rabassa-Mart?nez / ; Brandy Viera-Vald?s / ; Maydel de la C Armas-Ram?rez / ; Caridad M Guerrero / ; Gredsy Escand?n-L?pez / ; Carlos Manuel Hern?ndez-Ca?ete / ; Jes?s Tejidor-Fern?ndez / ; Jorge Lu?s Morales-Flor? / ; Misleny Alvarez Hern?ndez / ; Jorge Herrera-Zamora / ; Rolando Vegas-Garc?a / ; Mar?a Elena S?nchez-Montiel / ; Mar?a Esther Morgado-Carbonell / ; Odanay Fern?ndez-Castillo / ; Elida Menocal-Cabrera / ; Luisa Mar?a Boizant-Crombet / ; Alberto V?zquez-Proenza / ; Francisco A V??zquez-Milanes / ; Santiago Luna-Hern?ndez / ; H?ctor Rivera-Ortiz / ; Caridad Guerra-V?zquez / ; Enrique Men???ndez-Saborit / ; Julio Cesa L?pez-Gonz?lez / ; Roberto T Pelegrino-Reyes / ; Martha Corpas-Paneque / ; Jos? L Sol?s-Licea / ; Jos? Pablo Pose-Levive / ; Zulema Elliot-Perez / ; Lidia Sosa-Ramos / ; Estela Zaragoza-Alvare / ; Dulce B??ez-Escobar / ; Yusimi Trista-Area / ; Magnelia V??squez-Ruiz / ; Jos? E Sauri-Ch?vez / ; Maricela Rodr??guez-Betancourt / ; Pilar Herrera-Marturell / ; Azalia D?az-Gonzalez / ; Ofelia Bounet-Jim?nez / ; Jes?s Rodr?guez-Escribano / ; Armando Gonz?lez-Exp??sito / ; Esther Pe?a-Guillen / ; Envida Carballosa-Pe?a / ; Idania Hidalgos-Batista / ; Yanelis Silva-Ricardo / ; Ana?si Hern?ndez-Borges / ; Elio Lozano-Alvarez / ; Celso Su?rez-Lescay / ; Bencay Joa-Liranza / ; Inalvis Alfonseca-Miranda / ; Mar?a Cristina Smith-Mach? / ; Yolanda Rosabal-Poig / ; Julio Nu?ez-Vasquez / ; Amelie Esteva-Guas / ; Jorge A Rodriguez-Mayoral / ; Aimee Rodr?guez-Hern?ndez / ; Osmel Castillo-Luque / ; Remberto Garc?a-Gonz?lez / ; Susana Martinez / ; Edita B Thomas-Hay / ; Mirta Teresa Rodr?guez-Gutierrez / ; Lorena Cambert / ; Justa Pe?alver-Castillo / ; Lu?s Herrrera-B?ez / ; Enf Nixia Salas-Ge / ; Michelin Buscaron-Torres / ; Antonio Padua / ; Mileydis Stable-Walcott / ; Myrna Garcia-Meneses / ; Ileana Fern?ndez-Hidalgo / ; Miriam Avila-Nu?ez / ; Odalys M Gonz?lez-D?az / ; D?bora Monterrey-Cao / ; Grisel Soto-Arguelles / ; Clara Ballagas-Flores / ; Maria Amparo Pascual / ; Karina Miranda-Hern?ndez / ; Yoryana Ram?rez-Sanchez / ; Yurka Prieto-Ferro / ; Sandra A dela Naranjo-Rodriguez / ; Marisel Negret-Hern??ndez / ; Ana M Ramos-Cede?o / ; Leslie P?rez-Ruiz / ; Diana Rosa Fern??ndez-Ruiz / ; Maykel P?rez-Machin / ; Miriam Cid-Rios / ; Liliana Ramos-Torres / ; Hector Ruiz-Calabuch / ; Giselle Veguilla-Alomar / ; Thayde Trujillo-Tirado / ; Iliana P?rez-Chong / ; Ana R Valls-Hung / ; Janet Batista-Lorenzo / ; Norma Montes de Oca-Escobar / ; Zaimar Rodr?guez-Feria / ; Dulce Mari?o-Cruz / ; Heriberto Mart?nez-Su?rez / ; Doris Perdomo-Leyva / ; Elizabeth Pereira-Relis / ; Jorge A Silva-Valido / ; Rider Hern?ndez-Mart?nez / ; Carmen Valenzuela-Silva / ; Elizeth Garc?a-Iglesias / ; Leovaldo Alvarez-Falc?n / ; B Y Batancour / ; Amaurys del R?o-Mart?n / ; Yaleysis Rosales-Pantoja / ; Hugo Nodarse-Cun? / ; Cimara Berm?dez-Badell / ; Grettel Melo-Su?rez / ; Ketty Cruz-Chirino / ; Pedro A L?pez-Saura / ; Jorge Berlanga-Acosta / ; Luis Herrera-Mart?nez / ; Ernesto L?pez-Mola / ; Ricardo Silva-Rodr?guez / ; Marianela Garc?a /

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