title: 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.
abstract: 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.affiliation: JI Fernández-Montequín, MD, National Institute for Angiology and Vascular Surgery, Havana, Cuba.
authors.forename: José I
authors.initials: JI
authors.lastname: Fernández-Montequín
authors.forename: Carmen M
authors.initials: CM
authors.lastname: Valenzuela-Silva
authors.forename: Odalys González
authors.initials: OG
authors.lastname: Díaz
authors.forename: William
authors.initials: W
authors.lastname: Savigne
authors.forename: Natasha
authors.initials: N
authors.lastname: Sancho-Soutelo
authors.forename: Fidel
authors.initials: F
authors.lastname: Rivero-Fernández
authors.forename: Pablo
authors.initials: P
authors.lastname: Sánchez-Penton
authors.forename: Lourdes
authors.initials: L
authors.lastname: Morejón-Vega
authors.forename: Heriberto
authors.initials: H
authors.lastname: Artaza-Sanz
authors.forename: Arístides
authors.initials: A
authors.lastname: García-Herrera
authors.forename: Cecilio
authors.initials: C
authors.lastname: González-Benavides
authors.forename: Carlos M
authors.initials: CM
authors.lastname: Hernández-Cañete
authors.forename: Alberto
authors.initials: A
authors.lastname: Vázquez-Proenza
authors.forename: Jorge
authors.initials: J
authors.lastname: Berlanga-Acosta
authors.forename: Pedro A
authors.initials: PA
authors.lastname: López-Saura
mesh_terms: D000368:Aged; D017719:Diabetic Foot / Q000188:drug therapy* / Q000473:pathology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004815:Epidermal Growth Factor / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006097:Granulation Tissue / Q000187:drug effects* / Q000473:pathology; D006801:Humans; D015552:Injections, Intralesional; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000008:administration & dosage*; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects*
chemical_list: D011994:Recombinant Proteins; D004815:Epidermal Growth Factor