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news.Oculus Innovative Sciences has announced additional positive results from its US Phase II clinical trial evaluating Microcyn technology as a topical antimicrobial treatment for mildly infected diabetic foot ulcers.
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In the clinically evaluable population of the study, the clinical success rate at visit 3 (End of Therapy) for Microcyn-alone-treated patients was 77.8% compared to 61.1% for the levofloxacin plus saline treated patients.
The clinical success rate at visit 4 (Test of Cure) for Microcyn-alone-treated patients increased to 93.3% compared to 56.3% for the levofloxacin plus saline-treated patients (p= 0.033). This study was not statistically powered but the high clinical success rate (93.3%) and the p-value (0.033) would suggest the difference is meaningfully positive for the Microcyn-treated patients.
Andres Gutierrez, director of medical affairs at Oculus, said: “We feel this result, along with previously reported clinical success data in our phase II trial, supportive published results in the literature, and even data presented here at DFCon, all suggest that Microcyn technology has a potential significant role in the treatment of infected diabetic foot ulcers.”