The Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With Moderately Infected Foot Ulcers
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Intervention: gentamicin-collagen sponge and levofloxacin; Levofloxacin only
Intervention description: Topical Gentamicin Collagen Sponge: 10 × 10 cm in size And 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours.; levofloxacin, 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours
Intervention MeSH terms: Levofloxacin; Ofloxacin; Gentamicins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Diabetes; ulcers; ulcerations; infection

Summary:

      The purpose of this study is to determine whether the gentamicin-collagen sponge when
      combined with standard daily wound care and an oral antibiotic (levofloxacin) is safe and
      effective in treating moderately infected skin ulcers compared to treatment only with
      standard daily wound care and an oral antibiotic (levofloxacin).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is a man or woman aged ≥ 18 and ≤ 80 years.

          -  Has diabetes mellitus, according to the American Diabetes Association criteria.

          -  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

          -  Has had an x ray of the infected area within the 2 days immediately preceding or at
             Visit 1 (Baseline/Randomization) to document the presence or absence of osteomyelitis.
             Patients with osteomyelitis must receive appropriate surgical intervention to remove
             all necrotic and infected bone and otherwise meet enrollment criteria before being
             enrolled in the study.

          -  Meets certain minimal laboratory criteria

          -  Has an ankle brachial index (ABI) > or = 0.7 and ≤ 1.3. (Note: Patients with ABI < 0.7
             or > 1.3 may be included if they have either a transcutaneous oxygen pressure or a toe
             pressure > or = 40 mm Hg on limb with ulcer.)

          -  If female, is nonpregnant (negative pregnancy test results at the
             Baseline/Randomization Visit) and nonlactating.

          -  If female, is either not of childbearing potential (defined as postmenopausal for ≥ 1
             year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or
             hysterectomy]) or practicing a medically acceptable methods of birth control and
             agrees to continue with the regimen throughout the study

          -  Willing to return to the study facility for the Final Study Visit.

          -  Must be able to fluently speak and understand English and be able to provide
             meaningful written informed consent for the study.

        Exclusion Criteria:

          -  Has a known history of hypersensitivity to gentamicin (or other systemic
             aminoglycosides) or levofloxacin or drugs in the same class, or any of the test
             article or reference product components.

          -  Has a known hypersensitivity to bovine collagen.

          -  Has any uncontrolled illnesses that, in the opinion of the Investigator, would
             interfere with interpreting the results of the study.

          -  Has a target ulcer with a wound size > 10 × 10 cm.

          -  Has gangrenous tissue of the affected limb that cannot be removed with a single
             debridement.

          -  Has wound known to contain isolates resistant to levofloxacin.

          -  Has a wound associated with prosthetic material or device.

          -  Received any topical or systemic antimicrobial therapy within the 2 weeks prior to
             study entry (Visit 1 [Day 1]).

          -  If severely immunocompromised, may be excluded at the discretion of the Investigator.

          -  Has a history of alcohol or substance abuse in the past 12 months.

          -  Has serum creatinine > 3 mg/dL, is undergoing dialysis (renal or peritoneal) or has a
             history of kidney transplant.

          -  Has a history of myasthenia gravis or other neurological condition where gentamicin
             use is contraindicated as determined by the Investigator.

          -  Has a history of epilepsy

          -  Has a history of tendon disorders related to fluoroquinolone administration