Prevention of Infection Using a Topical Gentamicin-Collagen Sponge in Diabetic Patients With An Uninfected Foot Ulcer

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 skin ulcer below the knee, defined as "uninfected" by the Infectious Disease Society of America Guidelines (Wound lacking purulence or any manifestations of inflammation). * Has had an x-ray of the affected area within the 2 days immediately preceding or at Visit 1 (Baseline/Randomization) that is negative for osteomyelitis. * 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.) * Meets certain minimal laboratory criteria. * 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 at least 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 study: Oral, implantable or injectable contraceptives for 3 consecutive months before the Baseline/Randomization Visit. Total abstinence from sexual intercourse (minimum of 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 Posttreatment Evaluation 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 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 \> 5 × 5 cm. * Has gangrene or infection of the affected limb. * 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 history of myasthenia gravis or other neurological condition where gentamicin use is contraindicated as determined by the Investigator.