The Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With Moderately Infected Foot Ulcers

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innocoll
• Collaborator: Premier Research Group plc
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Gentamicins; Levofloxacin; Ofloxacin

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