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.
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.
Fernández-Montequín
José I
JI
JI Fernández-Montequín, MD, National Institute for Angiology and Vascular Surgery, Havana, Cuba.
Valenzuela-Silva
Carmen M
CM
Díaz
Odalys González
OG
Savigne
William
W
Sancho-Soutelo
Natasha
N
Rivero-Fernández
Fidel
F
Sánchez-Penton
Pablo
P
Morejón-Vega
Lourdes
L
Artaza-Sanz
Heriberto
H
García-Herrera
Arístides
A
González-Benavides
Cecilio
C
Hernández-Cañete
Carlos M
CM
Vázquez-Proenza
Alberto
A
Berlanga-Acosta
Jorge
J
López-Saura
Pedro A
PA
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*
D011994:Recombinant Proteins; D004815:Epidermal Growth Factor