Intralesional injections of Citoprot-P (recombinant human epidermal growth factor) in advanced diabetic foot ulcers with risk of amputation.
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.
Fernández-Montequín
José I
JI
Service of Diabetic Microangiopathy, National Institute for Angiology and Vascular Surgery, Havana, Cuba.
Infante-Cristiá
Ena
E
Valenzuela-Silva
Carmen
C
Franco-Pérez
Neobalis
N
Savigne-Gutierrez
William
W
Artaza-Sanz
Heriberto
H
Morejón-Vega
Lourdes
L
González-Benavides
Cecilio
C
Eliseo-Musenden
Osvaldo
O
García-Iglesias
Elizeth
E
Berlanga-Acosta
Jorge
J
Silva-Rodríguez
Ricardo
R
Betancourt
Blas Y
BY
López-Saura
Pedro A
PA
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*
D004815:Epidermal Growth Factor