Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Controlled, Open Label Study of the Safety and Efficacy of a Topical Gentamicin Collagen Sponge Combined With An Antibiotic Compared to Antibiotic Therapy Alone in Diabetic Patients With Moderately Infected Foot Ulcers
Brief 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).


Options:
A: 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
B: Inclusion Criteria:

* Non-hospitalized ambulatory patients with diabetes mellitus
* Men or Women greater than 18 years old
* Patients must be considered reliable, willing and able to give consent
* Female patients must be postmenopausal for a least 6 months or surgically sterilized
* Localized infection of the ulcer that would ordinarily be treated on an outpatient basis
* Patients who have been previously treated or are currently under treatment for a localized infections of an ulcer may be enrolled in there has been an adequate response to treatment and ulcer is still infected
* Patient must have radiograph within two weeks of entry showing no evidence of cortical destruction consistent with osteomyelitis
* Patient must have a palpable dorsalis pedis or posterior tibial pulse in the affected foot
* Patient may not be taking or have received any other investigational therapy or approved therapy within 30 days prior to entry

Exclusion Criteria:

* Patients requiring concurrent local or systemic antimicrobials during the study period for other infections
* Patients who are currently treated or awaiting dialysis
* Patients who are unable to care for their ulcers
* Patients with known alcohol or substance abuse within 6 months or study entry
* Patients with significant GI problems or surgery that might interfere with the absorption of ofloxacin
* Patients who are currently receiving systemic corticosteroids, immunosuppressives, antivirals, radiation therapy or cytotoxic agents
* Patients who currently require treatment or a primary or metastatic malignancy or have systemically immunocompromising disease.
* Previous enrollment in this study or previous treatment with MSI-78 Topical Cream
* Patients with gangrene or severely impaired arterial supply to any portion of the affected foot
* Other conditions considered by the investigator to be sound reason for disqualification
* Patients with any known allergy to ofloxacin, other quinolone antibiotics, magainin peptides or ingredients of the vehicle cream
* Women who are breast feeding, pregnant or attempting to become pregnant
C: Inclusion Criteria:

* Patients with Diabetes Mellitus Type 1 or 2.
* Patients with diabetic foot ulcers.
* Patients with clinical suspects of osteomyelitis.
* Patients with positive probe to bone test.
* Patients with signs of osteolysis in the bone located adjacent to the ulcer in X-Ray
* Patients with transcutaneous oxygen oxygenation above 30 mmHg.
* Acceptance to participate in the study through prior informed consent.

Exclusion Criteria:

* Patients with osteomyelitis associated with necrotizing soft tissue infections.
* Presence of necrotic tissue in the wound bed, edges or margins of the lesion.
* HbAc1 \> 10.
* Presence of systemic toxicity such as fever, tachycardia, confusion, disorientation, vomiting or other signs usually related to systemic infection.
* Patients with bone exposure through the ulcer.
* Patients with absent pulses, ankle/brachial index (ABI) \<0.8 and TcPO2 \<30 mmHg.
* Pregnancy.
* Allergies to antibiotics.
* Any degree of renal impairment that contraindicated the administration of antibiotics proposed.
* Hepatic insufficiency.
* Mental Illnesses that prevent the understanding by the patient's proposed treatment, or for any other reason associated with your mental health, to recommend their inclusion.
D: Inclusion Criteria:

* Non-hospitalized ambulatory patients with diabetes mellitus
* Men or Women greater than 18 years old
* Patients must be considered reliable, willing and able to give consent
* Female patients must be postmenopausal for a least 6 months or surgically sterilized
* Localized infection of the ulcer that would ordinarily be treated on an outpatient basis
* Patients who have been previously treated or are currently under treatment for a localized infections of an ulcer may be enrolled in there has been an adequate response to treatment and ulcer is still infected
* Patient must have radiograph within two weeks of entry showing no evidence of cortical destruction consistent with osteomyelitis
* Patient must have a palpable dorsalis pedis or posterior tibial pulse in the affected foot
* Patient may not be taking or have received any other investigational therapy or approved therapy within 30 days prior to entry

Exclusion Criteria:

* Patients requiring concurrent local or systemic antimicrobials during the study period for other infections
* Patients who are currently treated or awaiting dialysis
* Patients who are unable to care for their ulcers
* Patients with known alcohol or substance abuse within 6 months or study entry
* Patients with significant GI problems or surgery that might interfere with the absorption of ofloxacin
* Patients who are currently receiving systemic corticosteroids, immunosuppressives, antivirals, radiation therapy or cytotoxic agents
* Patients who currently require treatment or a primary or metastatic malignancy or have systemically immunocompromising disease.
* Previous enrollment in this study or previous treatment with MSI-78 Topical Cream
* Patients with gangrene or severely impaired arterial supply to any portion of the affected foot
* Other conditions considered by the investigator to be sound reason for disqualification
* Patients with any known allergy to ofloxacin, other quinolone antibiotics, magainin peptides or ingredients of the vehicle cream
* Women who are breast feeding, pregnant or attempting to become pregnant

Answer: A