Tego science said Thursday that it has confirmed the superior efficacy results of the application of Kaloderm, a homologous cell-based drug, on diabetic foot ulcers.
International Wound Journal published the research results.
Kaloderm is the only cell-based remedy for wound healing in Korea with indications for burns and diabetic foot ulcers. After receiving approval for treating burns in 2005, Tego Science managed to expand indications diabetic foot ulcer by proving its efficacy through a phase 3 clinical trial in 2010.
The research analyzed the results of applying Kaloderm to more patients with diabetic foot ulcers than in the previous clinical trials.
“The research is significant as the company has gained data on Kaloderm, a licensed drug that had proved its efficacy with clinical trials and post-marketing surveillance, in the actual medical field,” the company said.
The study analyzed the treatment results of 74 patients with diabetic foot ulcers who did not respond to conventional therapy, from April 2011 to June 2014, at Severance Hospital.
After applying Kaloderm once a week, the wound healed in an average of 7.8 weeks. The average size of the ulcer was 9 square centimeters, while the most massive ulcer was 78.9 square centimeters. There were no significant adverse events.
“Although Kaloderm was used to treat large-sized ulcers in an actual medical setting where various parameters are applied instead of a controlled clinical trial, it showed excellent therapeutic effects,” a company official said.