Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With a Mild Infection of a Foot Ulcer
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Intervention: gentamicin-collagen sponge; Levofloxacin
Intervention description: Inserted daily into open ulcer; 750mg oral levofloxacin daily
Intervention MeSH terms: Levofloxacin; Gentamicins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Diabetic Foot Ulcer

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          -  Is a man or woman aged 18 to 80 years.

          -  Has diabetes mellitus, according to the American Diabetes Association criteria.

          -  Has a single infected skin ulcer below the knee, defined as "mild" by the Infectious
             Disease Society of America (IDSA) Guidelines, for whom, in the Investigator's
             judgment, topical or oral antimicrobial therapy is appropriate (Mild infection
             severity: The presence of ≥ 2 manifestations of inflammation (purulence or erythema,
             pain, tenderness, warmth or induration) but any cellulitis/erythema extends ≤ 2 cm
             around the ulcer, and the infection is limited to the skin or superficial subcutaneous
             tissue, with no other local complications or acute, systemic illness).

          -  Has had an x-ray of the infected area within the 2 days immediately preceding or at
             Visit 1 (Baseline/Randomization) that is negative for osteomyelitis.

          -  Meets the certain minimal laboratory criteria

          -  Has an ankle-brachial index (ABI) ≥ 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 ≥ 40 mm Hg on the limb with the target ulcer.)

          -  If female, is nonpregnant (negative pregnancy tests 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 1 of the following medically-acceptable methods of birth
             control and agrees to continue with the regimen throughout the duration of the study:

               -  Oral, implantable or injectable contraceptives for 3 consecutive months before
                  the Baseline/Randomization Visit

               -  Total abstinence from sexual intercourse (≥ 1 complete menstrual cycle before the
                  Baseline/Randomization Visit)

               -  Intrauterine device (IUD)

               -  Double barrier method (condoms, sponge, diaphragm or vaginal ring with
                  spermicidal jellies or cream)

          -  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 an infecting pathogen known to be intermediate or resistant in vitro to
             levofloxacin. Patients enrolled into the study presumptively will be discontinued if
             their cultured organism is intermediate or resistant to levofloxacin.

          -  Has a target ulcer with a wound size > 5 × 5 cm.

          -  Has gangrenous tissue of the affected limb that cannot be removed with a single
             debridement.

          -  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]).

          -  Has documented osteomyelitis.

          -  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.

          -  Is undergoing dialysis (renal or peritoneal) or has 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