title: Intralesional administration of epidermal growth factor-based formulation (Heberprot-P) in chronic diabetic foot ulcer: treatment up to complete wound closure.
abstract: Previous studies have shown that an epidermal growth factor-based formulation (Heberprot-P) can enhance granulation of high-grade diabetic foot ulcers (DFU). The aim of this study was to explore the clinical effects of this administration up to complete wound closure. A pilot study in 20 diabetic patients with full-thickness lower extremity ulcers of more than 4 weeks of evolution was performed. Mean ulcer size was 16.3 +/- 21.3 cm(2). Intralesional injections of 75 microg of Heberprot-P three times per week were given up to complete wound healing. Full granulation response was achieved in all 20 patients in 23.6 +/- 3.8 days. Complete wound closure was obtained in 17 (85%) cases in 44.3 +/- 8.9 days. Amputation was not necessary in any case and only one relapse was notified. The most frequent adverse events were tremors, chills, pain and odour at site of administration and local infection. The therapeutic scheme of intralesional Heberprot-P administration up to complete closure can be safe and suitable to improve the therapeutic goal in terms of healing of chronic DFU.
authors.affiliation: National Institute for Angiology and Vascular Surgery, Havana, Cuba.
authors.forename: José I
authors.initials: JI
authors.lastname: Fernández-Montequín
authors.forename: Blas Y
authors.initials: BY
authors.lastname: Betancourt
authors.forename: Gisselle
authors.initials: G
authors.lastname: Leyva-Gonzalez
authors.forename: Ernesto L
authors.initials: EL
authors.lastname: Mola
authors.forename: Katia
authors.initials: K
authors.lastname: Galán-Naranjo
authors.forename: Mayte
authors.initials: M
authors.lastname: Ramírez-Navas
authors.forename: Sergio
authors.initials: S
authors.lastname: Bermúdez-Rojas
authors.forename: Felix
authors.initials: F
authors.lastname: Rosales
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-Rodriguez
authors.forename: Marianela
authors.initials: M
authors.lastname: Garcia-Siverio
authors.forename: Luis H
authors.initials: LH
authors.lastname: Martinez
mesh_terms: D000368:Aged; D017719:Diabetic Foot / Q000188:drug therapy* / Q000473:pathology; D004304:Dosage Forms; D004334:Drug Administration Schedule; D004815:Epidermal Growth Factor / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015552:Injections, Intralesional; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D016896:Treatment Outcome; D014945:Wound Healing
chemical_list: D004304:Dosage Forms; D004815:Epidermal Growth Factor