Treatment of Diabetic Ulcer using Autologous Fibroblast-Hyaluronic Acid Complex.

Eum, Soo Jin; Han, Seung Kyu; Gu, Ja Hea; Jeong, Seong Ho; Kim, Woo Kyung

Randomized Controlled Trial

Journal of the Korean Society of Plastic and Reconstructive Surgeons 2009;36(5):548-554.
Published online September 1, 2009.

Treatment of Diabetic Ulcer using Autologous Fibroblast-Hyaluronic Acid Complex.

Soo Jin Eum, Seung Kyu Han, Ja Hea Gu, Seong Ho Jeong, Woo Kyung Kim

Department of Plastic Surgery, Korea University College of Medicine, Seoul, Korea. pshan@kumc.or.kr

Abstract

PURPOSE
To evaluate clinical efficacy and safety of hyaluronic acid based autologous dermal fibroblasts (Hyalograft 3D) in the treatment of diabetic foot ulcers. METHODS: A total of 28 patients with diabetic ulcers were randomized to either the control group with nonadherent foam dressings(n=14) or the treatment group with autologous tissue-engineered grafts(n=14). Weekly assessment contained vital sign checks, ulcer size measurements, and wound photos. In the 12th week, percentages of complete wound healing and mean healing times were compared. Safety was also monitored by adverse events.
RESULTS
Complete wound healing was achieved in 84.6% of the treatment group and 23.1% of the control group(p<0.005). The mean times of closures for the treatment versus control groups were 6.1 weeks and 10.9 weeks, respectively. No adverse events related to the study treatment occurred.
CONCLUSION
The use of hyaluronic acid based autologous fibroblast grafts was found to be a safe and effective treatment for diabetic foot ulcers.

Keywords: Diabetic foot; Fibroblast cell therapy; Hyaluronic acid