Status:
COMPLETED
The Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With Moderately Infected Foot Ulcers
Lead Sponsor:
Innocoll
Collaborating Sponsors:
Premier Research
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 mo...
Detailed Description
Infected skin ulcers with diabetes can be very debilitating because they are difficult to heal. Diabetic ulcers are responsible for frequent health care visits, and are a major predictor of amputation...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00659646
Start Date
April 1 2008
End Date
February 1 2010
Last Update
January 27 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Karr Foot Kare PA
Lakeland, Florida, United States, 33813