The Safety and Efficacy of an Antibiotic Sponge in Diabet... | NCT00659646

NCT00659646

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Premier Research	OTHER

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Gentamicin sponge applied into wound plus levofloxacin, 750 mg by mouth (po) or intravenous (IV) every 24 hours or, if ulcer culture results show resistance to levofloxacin, alternative antimicrobial therapy as determined by susceptibility testing	Drug: gentamicin-collagen sponge and levofloxacin
B	Active Comparator	Levofloxacin, 750 mg po or IV every 24 hours or, if ulcer culture results show resistance to levofloxacin, alternative antimicrobial therapy as determined by susceptibility testing	Drug: Levofloxacin only

Interventions

Name	Type	Description	Arm Group Labels	Other Names
gentamicin-collagen sponge and levofloxacin	Drug	Topical Gentamicin Collagen Sponge: 10 × 10 cm in size And 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With a Clinical Cure at Visit 3 (Day 7)	Number of participants with a clinical cure in each treatment group at Visit 3 (Day 7). Clinical Cure is defined as positive clinical response and with pathogen eradication.	Day 7 of treatment

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With a Positive Clinical Response at Each Time Point	Number of patients with positive clinical response, defined as those with a clinical outcome of "clinical cure" or "clinical improvement" in each treatment group at/by each time point	Day 3, 7, 10,14, 21, 28 and 42
Number of Participants With a Clinical Cure at Each Visit Except Visit 3 (Day 7)

Eligibility Module

Eligibility 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

Name	Affiliation	Role
David Prior	Innocoll	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Karr Foot Kare PA		Lakeland	Florida	33813	United States

PubMed Identifier	Type	Citation	Retractions
22659765	Result	Lipsky BA, Kuss M, Edmonds M, Reyzelman A, Sigal F. Topical application of a gentamicin-collagen sponge combined with systemic antibiotic therapy for the treatment of diabetic foot infections of moderate severity: a randomized, controlled, multicenter clinical trial. J Am Podiatr Med Assoc. 2012 May-Jun;102(3):223-32. doi: 10.7547/1020223.

ID	Title	Description
FG000	Gentamicin-collagen Sponge and Levofloxacin	Gentamicin-collagen sponge and levofloxacin: Topical Gentamicin Collagen Sponge: 10 × 10 cm in size And 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours.
FG001	Levofloxacin	Levofloxacin only: levofloxacin, 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Gentamicin Sponge	Gentamicin sponge applied into wound plus levofloxacin, 750 mg by mouth (po) or intravenous (IV) every 24 hours or, if ulcer culture results show resistance to levofloxacin, alternative antimicrobial therapy as determined by susceptibility testing gentamicin-collagen sponge and levofloxacin: Topical Gentamicin Collagen Sponge: 10 × 10 cm in size And 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With a Clinical Cure at Visit 3 (Day 7)

Number of participants with a clinical cure in each treatment group at Visit 3 (Day 7). Clinical Cure is defined as positive clinical response and with pathogen eradication.

modified intent-to-treat

Posted

Count of Participants

Participants

Day 7 of treatment

ID	Title	Description
OG000	Gentamicin Sponge	Gentamicin sponge applied into wound plus levofloxacin, 750 mg by mouth (po) or intravenous (IV) every 24 hours or, if ulcer culture results show resistance to levofloxacin, alternative antimicrobial therapy as determined by susceptibility testing gentamicin-collagen sponge and levofloxacin: Topical Gentamicin Collagen Sponge: 10 × 10 cm in size And 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Gentamicin Sponge	Gentamicin sponge applied into wound plus levofloxacin, 750 mg by mouth (po) or intravenous (IV) every 24 hours or, if ulcer culture results show resistance to levofloxacin, alternative antimicrobial therapy as determined by susceptibility testing gentamicin-collagen sponge and levofloxacin: Topical Gentamicin Collagen Sponge: 10 × 10 cm in size And 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours.

ID	Term
D017719	Diabetic Foot
D003920	Diabetes Mellitus
D014456	Ulcer
D007239	Infections

ID	Term
D003925	Diabetic Angiopathies
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D016523	Foot Ulcer

ID	Term
D064704	Levofloxacin
D015242	Ofloxacin

ID	Term
D024841	Fluoroquinolones
D042462	4-Quinolones
D015363	Quinolones
D011804	Quinolines