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news.Innocoll has reported that dosing has commenced for the first of three planned Phase II clinical trials sponsored by its wholly owned subsidiary, Innocoll Technologies, to investigate CollaRx gentamicin topical for the treatment and prevention of infected diabetic foot ulcers.
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Innocoll plans to study CollaRx gentamicin topical for the treatment of diabetic foot infections of varying severity in a series of Phase II trials and has appointed the full-service clinical research organization, Premier Research Group, to coordinate the trials and provide US regulatory support.
The first of these trials is for the treatment of mildly infected diabetic ulcers, where the safety and efficacy of CollaRx gentamicin topical will be compared to an orally administered antibiotic.
This is a multi-centered trial performed at 10 sites, nine in the US and one in the UK. In two subsequent controlled, multi-centered Phase II trials due to commence in early 2008, Innocoll will investigate the product as an adjunct to systemic therapy for treating moderately infected ulcers and also as a therapy to prevent ulcers from becoming clinically infected.