title: Intralesional injections of Citoprot-P (recombinant human epidermal growth factor) in advanced diabetic foot ulcers with risk of amputation.
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.
authors.affiliation: Service of Diabetic Microangiopathy, National Institute for Angiology and Vascular Surgery, Havana, Cuba.
authors.forename: José I
authors.initials: JI
authors.lastname: Fernández-Montequín
authors.forename: Ena
authors.initials: E
authors.lastname: Infante-Cristiá
authors.forename: Carmen
authors.initials: C
authors.lastname: Valenzuela-Silva
authors.forename: Neobalis
authors.initials: N
authors.lastname: Franco-Pérez
authors.forename: William
authors.initials: W
authors.lastname: Savigne-Gutierrez
authors.forename: Heriberto
authors.initials: H
authors.lastname: Artaza-Sanz
authors.forename: Lourdes
authors.initials: L
authors.lastname: Morejón-Vega
authors.forename: Cecilio
authors.initials: C
authors.lastname: González-Benavides
authors.forename: Osvaldo
authors.initials: O
authors.lastname: Eliseo-Musenden
authors.forename: Elizeth
authors.initials: E
authors.lastname: García-Iglesias
authors.forename: Jorge
authors.initials: J
authors.lastname: Berlanga-Acosta
authors.forename: Ricardo
authors.initials: R
authors.lastname: Silva-Rodríguez
authors.forename: Blas Y
authors.initials: BY
authors.lastname: Betancourt
authors.forename: Pedro A
authors.initials: PA
authors.lastname: López-Saura
mesh_terms: D000328:Adult; D000368:Aged; D000671:Amputation, Surgical / Q000706:statistics & numerical data; D000704:Analysis of Variance; D003922:Diabetes Mellitus, Type 1 / Q000150:complications; D003924:Diabetes Mellitus, Type 2 / Q000150:complications; D017719:Diabetic Foot / Q000188:drug therapy* / Q000209:etiology / Q000601:surgery*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004815:Epidermal Growth Factor / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006097:Granulation Tissue / Q000187:drug effects; D006801:Humans; D015552:Injections, Intralesional; D008297:Male; D008875:Middle Aged; D011336:Probability; D018570:Risk Assessment; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects*
chemical_list: D004815:Epidermal Growth Factor