Results of Clinical Study Evaluating Treatment of Diabetic Foot Ulcers Using Microcyn(TM) Technology Presented at Stuttgart2005.STUTTGART, Germany -- 218-patient study indicates Microcyn(TM) Technology superior in microbial microbial pertaining to or emanating from a microbe. microbial digestion the breakdown of organic material, especially feedstuffs, by microbial organisms. load reduction, healing time, surgical dehiscence dehiscence /de·his·cence/ (de-his´ins) a splitting open. wound dehiscence separation of the layers of a surgical wound. de·his·cence n. and adverse side effects as compared to povidone iodine (10%) Oculus oculus (Latin: “eye”) In architecture, any of several elements resembling an eye, such as a round or oval window or the round opening at the top of some domes (see Pantheon). Innovative Sciences, Inc. announced 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(TM) Technology in treating diabetic foot ulcers as compared to povidone iodine (10%) antiseptic, which is often used as the "standard care" in treatment of open wounds. In the study, the Microcyn(TM) 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(TM) 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% of ulcers in the Microcyn(TM) group had a negative microbiological specimen versus 68.5% of ulcers in the povidone iodine group. The Microcyn(TM) 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 Morbidity and Mortality can refer to:
Peripheral vascular disease is a narrowing of blood vessels that restricts blood flow. It mostly occurs in the legs, but is sometimes seen in the arms. is the most important prognostic factor for the risk of amputation amputation (ăm'pyətā`shən), removal of all or part of a limb or other body part. Although amputation has been practiced for centuries, the development of sophisticated techniques for treatment and prevention of infection has greatly 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(TM) Technology was a retrospective, open-label single-center (Abano Terme Hospital) study conducted by Dr. Dalla Paola. The results were presented at Stuttgart2005, an international wound management conference jointly sponsored by the European Wound Management Association (EWMA EWMA Exponentially Weighted Moving Average EWMA Embedded Wireless Multicast Advantage EWMA Environmental Waste Management Associates ), the European Tissue Repair Society (ETRS ETRS European Terrestrial Reference System ETRS ELINT Targeting & Reconnaissance Satellite ) and Deutsche Gesellschaft fur Wundheilung and Wundbehandlung e.V. (DsfW). "In light of the positive evidence generated by this study," said Dr. Dalla Paola, "my associates and I are highly enthusiastic about Microcyn's 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 burns -- essentially in any wound where infection is a challenge." Regulatory Oculus Innovative Sciences, the developer and manufacturer of the Microcyn(TM) Technology, received CE approval according to the European Medical Devices Directive You can improve this article by adding links to related material, within the existing text. After links have been created, remove this message. For more information, see the . Two FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. 510K clearances were also received in May 2005 to market Dermacyn(TM)Wound Care (formulated with the Microcyn(TM) Technology) in the United States as a medical device to lubricate lu·bri·cate v. lu·bri·cat·ed, lu·bri·cat·ing, lu·bri·cates v.tr. 1. To apply a lubricant to. 2. To make slippery or smooth. v.intr. To act as a lubricant. , moisten, cleanse and debride de·bride·ment n. Surgical excision of dead, devitalized, or contaminated tissue and removal of foreign matter from a wound. [French débridement, from débrider, wounds and burns. Dermacyn(TM) 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. About Oculus Oculus Innovative Sciences, headquartered in Petaluma, California has developed a proprietary technology platform, Microcyn(TM) super-oxidized water. The Microcyn(TM) 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 MRSA Methicillin-resistant Staphylococcus aureus. See MARSA. , Methicillan-Resistant Staphylococcus; and VRE VRE vancomycin-resistant enterococcus. VRE Vancomycin-resistent enterococcus, see there , Vancomycin-resistant Enterococcus, in vitro), viruses, spores, and fungi. Oculus' principal operations are in Petaluma, California, and it conducts operations in Europe and Latin America through its wholly-owned subsidiaries, Oculus Innovative Sciences Netherlands B.V. and Oculus Technologies of Mexico, S.A. de C.V. Please visit us at www.oculusis.com. Forward-Looking Statements This press release contains forward-looking statements that involve risks and uncertainties. These forward-looking statements relate to, among other things, the attributes of our products and their use in various markets. Our expectations as expressed in this press release depend upon our ability to develop, manufacture and supply products that meet defined specifications. When used in this press release, the words "plan," "expect," "believe," and similar expressions generally identify forward-looking statements. These statements reflect our current expectations. They are subject to a number of risks and uncertainties, including, but not limited to, changes in technology and changes in the health sciences market. In light of the many risks and uncertainties surrounding this market, you should understand that we cannot assure you that the forward-looking statements contained in this press release will be realized. |
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