• José I Fernández-Montequín, Ena Infante-Cristiá, Carmen Valenzuela-Silva, Neobalis Franco-Pérez, William Savigne-Gutierrez, Heriberto Artaza-Sanz, Lourdes Morejón-Vega, Cecilio González-Benavides, Osvaldo Eliseo-Musenden, Elizeth García-Iglesias, Jorge Berlanga-Acosta, Ricardo Silva-Rodríguez, Blas Y Betancourt, Pedro A López-Saura, and Cuban Citoprot-P Study Group.
• Service of Diabetic Microangiopathy, National Institute for Angiology and Vascular Surgery, Havana, Cuba.
• Int Wound J. 2007 Dec 1; 4 (4): 333-43.

AbstractTo investigate the efficacy and safety of recombinant human epidermal growth factor (rhEGF) in advanced diabetic foot ulcers (DFU) A double-blind trial was carried out to test two rhEGF dose levels in type 1 or 2 diabetes patients with Wagner's grade 3 or 4 ulcers, with high risk of amputation. Subjects were randomised to receive 75 (group I) or 25 mug (group II) rhEGF through intralesional injections, three times per week for 5-8 weeks together with standardised good wound care. Endpoints were granulation tissue formation, complete healing and need of amputation. Safety was assessed by clinical adverse events (AEs) and laboratory evaluations. Forty-one patients were included. After 5-8 weeks of treatment, 83% patients in the higher dose group and 61% in group II achieved useful granulation tissue covering more than 98% of the wound area. At long-term assessment, 13 (56.5%) patients healed in group I and 9 (50%) in group II. The mean time to complete healing in group I was 20.6 weeks (95% CI: 17.0-24.2) and 19.5 weeks (16.3-22.7) in group II. After 1-year follow-up, only one patient relapsed. Amputation was not necessary in 65% and 66.7% of groups I and II, respectively. The AEs rates were similar. The most frequent were sepsis (33%), burning sensation (29%), tremors, chills and local pain (25% each). rhEGF local injection enhances advanced DFU healing and reduces the risk of major amputation. No dose dependency was observed.

36 keywords...

hide…