A Randomized, Controlled, Open-Label Study to Investigate the Safety and Efficacy

INTERVENTION: Product Name: gentamicin collagen sponge Pharmaceutical Form: Medicated sponge INN or Proposed INN: Gentamicin Sulfate CAS Number: 1404‐41‐0 Concentration unit: mg milligram(s) Concentration type: range Concentration number: 50,‐200 Trade Name: Tavanic (levofloxacin) Product Name: Tavanic Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Levofloxacin CAS Number: 100986‐85‐4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 750‐ CONDITION: Diabetic patients with a moderate infection of a lower extremity skin ulcer ; MedDRA version: 9.1 Level: LLT Classification code 10012664 Term: Diabetic foot ulcer PRIMARY OUTCOME: Main Objective: To determine the effect of the Collatamp G® Topical; Gentamicin‐Collagen Sponge (gentamicin sponge) in combination with; antimicrobial therapy compared to antimicrobial therapy alone on; patients’ clinical outcome in the treatment of moderately infected skin; ulcers Primary end point(s): Percent of patients with a clinical outcome of “clinical cure” in each; treatment group at Visit 3 (Day 7); ; Clinical cure is defined as: The resolution of all signs and symptoms of infection(purulence or evidence of inflammation) tht were present at enrollment and the patient requires no further antimicrobial therapy or surgical intervention to treat the infection. Secondary Objective: • To determine the effect of the gentamicin sponge in combination with; antimicrobial therapy compared to antimicrobial therapy alone on; eradication of wound pathogens; • To assess the effect of the gentamicin sponge in combination with; antimicrobial therapy compared to antimicrobial therapy alone on; absolute and percent decrease of total wound surface area; • To assess the safety and tolerability of the gentamicin sponge in; combination with antimicrobial therapy; • To assess the systemic exposure to gentamicin following the; administration of the gentamicin sponge by measuring serum; gentamicin concentrations in a subset of patients at various time points; after applying the gentamicin sponge INCLUSION CRITERIA: Is a man or woman aged = 18 and = 80 years. 2. Has diabetes mellitus, according to the American Diabetes Association criteria. 3. Has a single infected skin ulcer below the knee, defined as “moderate” by the Infectious Disease Society of America (IDSA) Guidelines for whom, in the Investigator’s opinion, intravenous (IV) or oral antimicrobial therapy is appropriate (IDSA Guidelines, CID 204;39:885‐910). Moderate infection severity guideline: Infection in a patient who is systemically well and metabolically stable characterized by the presence of = 2 manifestations of inflammation (purulence or erythema, pain, tenderness, warmth, or induration) that has = 1 of the following characteristics: cellulitis extending 2 cm, lymphangitic streaking, spread beneath the superficial fascia, deep‐tissue abscess, gangrene, and involvement of muscle, tendon, joint or bone. 4. Has had an x‐ray of the infected area within the 2 days