Efficacy and Safety of Garamycin® Sponge in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection

Inclusion Criteria: * Is aged ≥ 18. * Has diabetes mellitus, according to the American Diabetes Association (ADA) criteria. * Has an open foot wound with visible inflammation, namely at least 1 skin ulcer located on or below the malleolus that presents with the following clinical manifestations of a moderate or severe infection based on the Infectious Disease Society of America (IDSA). * Has received appropriate surgical intervention to remove all necrotic and infected bone if diagnosed with osteomyelitis * Meets certain minimal laboratory criteria. Exclusion Criteria: * Has an ulcer infection which, based upon the patient's known history of hypersensitivity cannot be appropriately treated with at least one of the empiric systemic antibiotic regimens per protocol. * Has received \> 48 hours of potentially effective antibiotic therapy and the wounds are clinically improving. If a patient has received an antibiotic within 72 hours, but is not improving or deep-tissue culture results indicate that the infecting pathogen is not susceptible to that antibiotic, the patient may be enrolled. * Requires or is likely to require treatment with any concomitant topical product or wound therapy during the study period.