CollaRx Gentamicin Topical is currently under investigation for the treatment and prevention of diabetic foot infections of varying severity in a series of multi-centered Phase II clinical trials. The first and second trials are investigating the product as a mono-antibiotic therapy for the treatment of mildly infected diabetic ulcers and as an adjunct to systemic antibiotic therapy for treating moderately infected ulcers, as defined according to Infectious Disease Society of America guidelines. This third and final Phase II trial will investigate the product for the prevention of diabetic foot infections.
CollaRx Gentamicin Topical is a biodegradable and fully resorbable Gentamicin-Collagen Sponge formulated and manufactured using Innocoll’s proprietary collagen-based drug delivery technology, CollaRx. Upon application to a wound, the product releases gentamicin, a broad-spectrum, aminoglycoside antibiotic (having a concentration-dependent mechanism of action), for local action. This achieves a high concentration of drug at the target tissue, while maintaining low systemic levels well below the toxicity threshold.