STUTTGART, Germany -- Oculus Innovative Sciences, Inc. announces that Dr. Luca Dalla Paola, a surgeon with the diabetic foot unit of the Abano Terme Hospital in Italy, recently presented the results of a 218-patient controlled clinical study that assessed the safety and efficacy of Microcyn technology in treating diabetic foot ulcers as compared to povidone iodine (10 percent) antiseptic, which is often used as the standard care in treatment of open wounds.
In the study, the Microcyn technology proved superior to the iodine relative to the reduction of the number of bacterial strains, local adverse effects, surgical dehiscence (incidence of not healing after surgery due to infection or ischemia) and healing time. The key endpoint of the study was microbial load reduction at both entry and at surgery (or follow-up). The Microcyn technology showed a significantly improved rate of reduction of microbial load and healing time in open wounds as compared to the povidone iodine group; 88.2 percent of ulcers in the Microcyn group had a negative microbiological specimen vs. 68.5 percent of ulcers in the povidone iodine group. The Microcyn group showed no local adverse effects, while the povidone iodine group experienced 18 incidences of such effects.
Foot ulcers are a common complication of diabetes and account for high morbidity and mortality. Infection in the presence of this peripheral vascular disease is the most important prognostic factor for the risk of amputation in the diabetic foot. Antibiotic therapy, surgical treatment of deep infection and antiseptic dressings are commonly used to treat infection in the diabetic foot. While local antiseptic agents are widely used, there is little data about their efficacy.
This first European study using Microcyn technology was a retrospective, open-label single-center study conducted by Dalla Paola. The results were presented at Stuttgart2005, an international wound management conference jointly sponsored by the European Wound Management Association (EWMA), the European Tissue Repair Society (ETRS) and Deutsche Gesellschaft für Wundheilung and Wundbehandlung e.V. (DsfW).
In light of the positive evidence generated by this study, said Dalla Paola, my associates and I are highly enthusiastic about Microcyns potential to redefine the standard of treatment in diabetic foot ulcers. This study certainly warrants further examination of this super-oxidized water formula, not only in the treatment of diabetic foot ulcers, but also in dealing with other chronic wounds and burnsessentially in any wound where infection is a challenge.
Oculus Innovative Sciences, the developer and manufacturer of the Microcyn technology, received CE approval according to the European Medical Devices Directive (93/42/EEC) for Dermacyn Wound Care in November 2004. It was certified as a Class IIb medical device for treating acute and chronic wounds (e.g., diabetic foot ulcers and burns) as part of a comprehensive wound care regimen. Two FDA 510K clearances were also received in May 2005 to market Dermacyn Wound Care (formulated with the Microcyn technology) in the United States as a medical device to lubricate, moisten, cleanse, and debride wounds and burns. Dermacyn Wound Care also received regulatory approval in November 2004 from the Therapeutic Product Directorate, the Canadian federal authority that regulates pharmaceutical drugs and medical devices, as a dermal wound irrigant that facilitates removal of wound debris as it cleanses and debrides. The technology has also received antiseptic approval in Mexico for treatment of open wounds.
Oculus Innovative Sciences, headquartered in Petaluma, Calif., has developed a proprietary technology platform, Microcyn super-oxidized water. The Microcyn technology is a non-toxic, shelf-stable anti-microbial which has been proven effective in safely and quickly killing bacteria (including antibiotic-resistant strains such as MRSA and VRE, in vitro), viruses, spores, and fungi.
Source: Oculus Innovative Sciences