Author(s): FernndezMontequn JI, InfanteCristi E, ValenzuelaSilva C, FrancoPrez N, SavigneGutierrez W,
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Abstract To 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.
This article was published in Int Wound J
and referenced in Journal of Diabetes & Metabolism