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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

2009; Wiley; Volume: 6; Issue: 6 Linguagem: Inglês

10.1111/j.1742-481x.2009.00641.x

1742-481X

José I Fernández‐Montequín, Carmen Valenzuela‐Silva, Odalys González Díaz, William Savigne, Natasha Sancho‐Soutelo, Fidel Rivero‐Fernández, Pablo Sánchez‐Penton, Lourdes Morejón‐Vega, Heriberto Artaza‐Sanz, Arístides García‐Herrera, Cecilio González‐Benavides, Carlos M Hernández‐Cañete, Alberto Vázquez‐Proenza, Jorge Berlanga‐Acosta, Pedro López‐Saura,

Pressure Ulcer Prevention and Management

Fernández‐Montequín JI, Valenzuela‐Silva CM, González Díaz O, Savigne W, Sancho‐Soutelo N, Rivero‐Fernández F, Sánchez‐Penton P, Morejón‐Vega L, Artaza‐Sanz H, García‐Herrera A, González‐Benavides C, Hernández‐Cañete CM, Vázquez‐Proenza A, Berlanga‐Acosta J, López‐Saura PA, for the Cuban Diabetic Foot Study Group. 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 µg) or placebo, three times per week for 8 weeks and standard good wound care. The main endpoint was granulation tissue covering ≥ 50% of the ulcer at 2 weeks. It was achieved by 19/48 controls versus 44/53 in the 75 µg group [odds ratio (OR): 7·5; 95% confidence interval (CI): 2·9–18·9] and 34/48 in the 25 µg 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 µg and 34/48 with 25 µg 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 µg and 25/48 with 25 µg EGF) were also treatment dependent. Multivariate analyses yielded that they were significantly enhanced by 75 µg 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.