Derma Sciences’ diabetic foot ulcer treatment DC127 has met the primary and secondary endpoints of a Phase II clinical trial.
The double-blind, placebo-controlled, and multi-centre clinical trial enrolled 80 patients who were randomised to receive one of two dose strengths of DSC127 (0.03% and 0.01%) or a placebo.
In the intent-to-treat population, the study results showed that 54% of the patients treated with the 0.03% dose of DSC127 and 30% of patients treated with 0.01% dose achieved 100% diabetic wound closure in 12 weeks or less, the primary endpoint, compared to 33% of patients receiving the placebo.
Based on odds ratio analysis, patients receiving DSC127 0.03% were 2.3 times more likely to have their wounds healed compared to patients receiving placebo / standard of care.
In the per-protocol population, 65% of the patients treated with the 0.03% dose of DSC127 and 38% of patients treated with 0.01% dose achieved 100% diabetic wound closure in 12 weeks or less, compared to 28% of patients receiving the placebo.
Based on odds ratio analysis, per-protocol patients receiving DSC127 0.03% were three times more likely to have their wounds healed compared to patients receiving placebo / standard of care.
The drug was well-tolerated in the study, with no significant adverse events.
DSC127 is a patented, topically applied novel angiotensin analogue that targets the receptors that are up-regulated following injury to tissue.
