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Am J Transl Res 2012;4(1):52-59
Original Article
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
Naoki Morimoto, Kenichi Yoshimura., Miyuki Niimi, Tatsuya Ito, Harue Tada, Satoshi Teramukai, Toshinori
Murayama, Chikako Toyooka, Satoru Takemoto, Katsuya Kawai, Masayuki Yokode, Akira Shimizu, Shigehiko
Suzuki
Department of Plastic and Reconstructive surgery, Graduate School of Medicine, Kyoto University; Department of
Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital; Department of
Experimental Therapeutics, Translational Research Center, Kyoto University Hospital; Department of Clinical
Innovative Medicine, Translational Research Center, Kyoto University Hospital, Japan.
Received October 17, 2011; accepted November 20, 2011; Epub January 5, 2012; Published January 15, 2012
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/Design: 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/ cm2 or 14μg/ cm2 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. Conclusion: 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. (AJTR1110002).
Keywords: Artificial dermis, basic fibroblast growth factor, skin ulcers, sustained release
Full Text PDF
Address all correspondence to:
Naoki Morimoto, MD, PhD
Department of Plastic and Reconstructive Surgery,
Graduate School of Medicine, Kyoto University, 54
Kawahara-cho Shogoin, Sakyo-ku, Kyoto 606-8507,
Japan.
Phone: +81-75-751-3613; FAX：+ 81-75-751-4340
E-mail: mnaoki22@kuhp.kyoto-u.ac.jp
Original Article
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
Naoki Morimoto, Kenichi Yoshimura., Miyuki Niimi, Tatsuya Ito, Harue Tada, Satoshi Teramukai, Toshinori
Murayama, Chikako Toyooka, Satoru Takemoto, Katsuya Kawai, Masayuki Yokode, Akira Shimizu, Shigehiko
Suzuki
Department of Plastic and Reconstructive surgery, Graduate School of Medicine, Kyoto University; Department of
Clinical Trial Design and Management, Translational Research Center, Kyoto University Hospital; Department of
Experimental Therapeutics, Translational Research Center, Kyoto University Hospital; Department of Clinical
Innovative Medicine, Translational Research Center, Kyoto University Hospital, Japan.
Received October 17, 2011; accepted November 20, 2011; Epub January 5, 2012; Published January 15, 2012
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/Design: 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/ cm2 or 14μg/ cm2 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. Conclusion: 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. (AJTR1110002).
Keywords: Artificial dermis, basic fibroblast growth factor, skin ulcers, sustained release
Full Text PDF
Address all correspondence to:
Naoki Morimoto, MD, PhD
Department of Plastic and Reconstructive Surgery,
Graduate School of Medicine, Kyoto University, 54
Kawahara-cho Shogoin, Sakyo-ku, Kyoto 606-8507,
Japan.
Phone: +81-75-751-3613; FAX：+ 81-75-751-4340
E-mail: mnaoki22@kuhp.kyoto-u.ac.jp
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