title: An exploratory clinical trial for combination wound therapy with a novel medical matrix and fibroblast growth factor in patients with chronic skin ulcers: a study protocol.
abstract: BACKGROUND
  Chronic skin ulcers such as diabetic ulcers and venous leg ulcers are increasing and are a costly problem in health care. We have developed a novel artificial dermis, collagen/gelatin sponge (CGS), that is capable of the sustained release of basic fibroblast growth factor (bFGF) for more than 10 days. The objective of this study was to investigate the safety and efficacy of CGS impregnated with bFGF in the treatment of chronic skin ulcers. Methods/
  
  
  METHODS
  Seventeen patients (≥ 20 years of age) with chronic skin ulcers that have not healed by conventional therapy for at least 4 weeks are being recruited. Patients will be applied with CGS impregnated with bFGF of 7 μg/cm(2) or 14 μg/cm(2) after debridement, and the wound bed improvement will be assessed 14 days after application. "Wound bed improvement" is defined as a granulated and epithelialized area on Day 14 in proportion to the baseline wound area after debridement of 50% or higher. Patients will be followed up until 28 days after application to observe the adverse events related to the application of CGS.
  
  
  CONCLUSIONS
  This study has been designed to address the safety and efficacy of CGS impregnated with bFGF. If successful, this intervention may be an alternative to bioengineered skin substitutes and lead to substantial and important changes in the management of chronic skin ulcers such as diabetic ulcers and venous ulcers.
authors.forename: Naoki
authors.initials: N
authors.lastname: Morimoto
authors.forename: Kenichi
authors.initials: K
authors.lastname: Yoshimura
authors.forename: Miyuki
authors.initials: M
authors.lastname: Niimi
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Ito
authors.forename: Harue
authors.initials: H
authors.lastname: Tada
authors.forename: Satoshi
authors.initials: S
authors.lastname: Teramukai
authors.forename: Toshinori
authors.initials: T
authors.lastname: Murayama
authors.forename: Chikako
authors.initials: C
authors.lastname: Toyooka
authors.forename: Satoru
authors.initials: S
authors.lastname: Takemoto
authors.forename: Katsuya
authors.initials: K
authors.lastname: Kawai
authors.forename: Masayuki
authors.initials: M
authors.lastname: Yokode
authors.forename: Akira
authors.initials: A
authors.lastname: Shimizu
authors.forename: Shigehiko
authors.initials: S
authors.lastname: Suzuki