Derma Sciences announced that all data from the pharmacokinetic study with 0.03% DSC127 gel has been collected and analyzed. The open-label, single center, Phase 1 study enrolled 21 diabetic subjects with at least one chronic non-healing Wagner Grade 1 or 2 plantar neuropathic foot ulcer(s) on the mid and fore foot that was at least 3.0 cm2. Subjects topically applied 0.03% DSC127 to the wound once each day for 28 days. Study subjects showed no clinically significant changes in clinical chemistry, hematology, and electrocardiograms. The 0.03% DSC127 gel was well tolerated and there were no adverse events or serious adverse events considered related to the study drug. This PK study was required by the FDA as part of the company's development program.
- Pharmaceuticals & Drug Trials