title: Clinical efficacy of basic fibroblast growth factor (bFGF) for diabetic ulcer.
abstract: Basic fibroblast growth factor (bFGF) has been shown to promote wound healing. The present trial evaluated the clinical efficacy of bFGF for diabetic ulcer, a type of refractory skin ulcer, and the dose-response relationship. This was designed as a randomized, double-blind, dose-ranging, placebo-controlled trial. A total of 150 patients with non-ischaemic diabetic ulcers measuring 900 mm2 or less were randomized into a placebo group (n = 51), a 0.001% bFGF group (n = 49) and a 0.01% bFGF group (n = 50), and 148 of these patients received treatment for 8 weeks or less. The efficacy evaluation was carried out on 139 patients who met the protocol in this trial. The primary outcome was the percentage of patients showing 75% or greater reductions in the area of ulcer. The area of ulcer decreased by 75% or more in 57.5% (27/47), 72.3% (34/47), and 82.2% (37/45) in the placebo, 0.001% bFGF and 0.01% bFGF groups, respectively, and differences were significant between the 0.01% bFGF and placebo groups (p = 0.025). The cure rate was 46.8% (22/47), 57.4% (27/47), and 66.7% (30/45) in the placebo, 0.001% bFGF and 0.01% bFGF groups, respectively. The findings obtained in this trial showed wound healing accelerating effects of bFGF on diabetic ulcers.
authors.affiliation: Department of Dermatology, Kyushu University Hospital, 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan. uchihir@dermatol.med.kyushu-u.ac.jp
authors.forename: Hiroshi
authors.initials: H
authors.lastname: UCHI
authors.forename: Atsuyuki
authors.initials: A
authors.lastname: IGARASHI
authors.forename: Kazunori
authors.initials: K
authors.lastname: URABE
authors.forename: Tetsuya
authors.initials: T
authors.lastname: KOGA
authors.forename: Juichiro
authors.initials: J
authors.lastname: NAKAYAMA
authors.forename: Ryuzo
authors.initials: R
authors.lastname: KAWAMORI
authors.forename: Kunihiko
authors.initials: K
authors.lastname: TAMAKI
authors.forename: Hideki
authors.initials: H
authors.lastname: HIRAKATA
authors.forename: Takehiko
authors.initials: T
authors.lastname: OHURA
authors.forename: Masutaka
authors.initials: M
authors.lastname: FURUE
mesh_terms: D000328:Adult; D000368:Aged; D017719:Diabetic Foot / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D016222:Fibroblast Growth Factor 2 / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged
chemical_list: D016222:Fibroblast Growth Factor 2