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

NCT00659646 | Completed Phase 2 Results

• 1 other identifier: INN-TOP-003
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetic Foot Ulcer

Keywords

Diabetes; ulcers; ulcerations; infection

Outcome Measures

Primary Outcomes (1)

• 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 (7)

• Number of Participants With a Positive Clinical Response at 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)

  Day 3, 10, 14, 21, 28 & 42

• Number of Participants With Pathogen Eradication by Visit

  Day 3, 7, 10, 14, 21 & 28

• Change From Baseline in Total Wound Surface Area Measured in cm^2

  Day 3, 7, 10, 14, 21, 28 & 42

• Time to Clinical Cure

  Days 1 through 49

Study Arms (2)

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

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.

Also known as: Collatamp G

A

Levofloxacin only DRUG

levofloxacin, 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours

Also known as: Tavanic, Levaquin

B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Innocoll: lead
• Premier Research: collaborator

Study Sites (1)

Karr Foot Kare PA

Lakeland, Florida, 33813, United States

Location

Related Publications (1)

• 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.

  PMID: 22659765 RESULT

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus; Ulcer; Infections

Interventions

Levofloxacin; Ofloxacin

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Charlene A. Tucker, MS Executive Director, Medical Writing and Document Management
• Organization: Innocoll

ctucker@innocoll.com

484-406-5211

Study Officials

• David Prior

  Innocoll

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2008
• First Posted: April 16, 2008
• Study Start: April 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: February 1, 2010
• Last Updated: January 27, 2022
• Results First Posted: August 30, 2021

Record last verified: 2022-01

Locations

US (1)