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Oculus Innovative Sciences Completes Patient Treatment In Phase II Study Of Microcyn Technology To Treat Patients With Diabetic Foot Ulcers

By RTTNews Staff Writer   ✉   | Published:   | Follow Us On Google News
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Thursday, Oculus Innovative Sciences, Inc. (OCLS), a manufacturer of various products to treat chronic wounds, said that it has completed patient treatment and follow-up in its randomized and controlled Phase II study of Microcyn Technology to treat patients with mildly infected diabetic foot ulcers. The final patient evaluation occurred on December 24, 2007.

The company said that the primary objective of the Phase II trial is to provide the clinical basis and rationale for larger Phase III trials. The company expects to provide preliminary top line Phase II clinical trial results in Q1 of 2008.

The patients enrolled in this trial have been screened to ensure that they have appropriate blood perfusion, thus enabling the antibiotic levofloxacin the opportunity to access and impact the infected ulcer.

The three treatment arms of the trial are topical microcyn alone, topical microcyn in combination with oral levofloxacin and topical saline in combination with oral levofloxacin. Levofloxacin was chosen for the control group because it is one of the more potent, broad-spectrum oral antibiotics indicated for the treatment of complicated skin and skin structure infections.

Patient enrollment criteria in all three arms of the study included appropriate blood perfusion as well as mildly infected ulcers based on the IDSA classification of mild and University of Texas wound classification of 1B.

OCLS' stock is currently trading at $4.48, up $0.30 or 7.17% from its previous closing.

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