Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With a Mild Infection of a Foot Ulcer

NCT00593567 | Completed Phase 2 Results

• 1 other identifier: INN-TOP-001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the gentamicin-collagen sponge when combined with standard of daily wound care is safe and effective in treating mildly infected skin ulcers compared to treatment with an oral antibiotic (levofloxacin) and standard daily wound care.

Conditions

Diabetic Foot Ulcer

Keywords

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Clinical Outcome of "Clinical Cure"

  Number of Participants with a clinical outcome of "clinical cure" at final visit. Clinical Cure is defined as positive clinical response and with pathogen eradication.

  Final Study Visit (Day 21 [or 28 or 35])

Secondary Outcomes (6)

• Number of Participants With a Clinical Outcome of "Clinical Cure" in Each Treatment Group

  Each time point (Day 3, 7 [14 and 21 if necessary])

• Time to Baseline Pathogen Eradication

  assessed at each time point on days 7, 14, 21, time to pathogen eradication from baseline up to day 21 reported

• Number of Participants With Complete Wound Closure by Each Visit

  At each timepoint Day 3, 7, 14 & 21

• Time to Clinical Cure

  Actual time assessed (Day 1, 3, 7 [14 and 21 if necessary] and Day 21 [or 28 or 35])

• Time to Pathogen Eradication

  Actual time assessed (Day 1-21

Study Arms (2)

A

EXPERIMENTAL

Daily topical gentamicin sponge and standard daily wound care

Drug: gentamicin-collagen sponge

B

ACTIVE COMPARATOR

Daily oral levofloxacin 750 mg and standard daily wound care

Drug: Levofloxacin

Interventions

gentamicin-collagen sponge DRUG

Inserted daily into open ulcer

A

Levofloxacin DRUG

750mg oral levofloxacin daily

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 to 80 years.
• Has diabetes mellitus, according to the American Diabetes Association criteria.
• Has a single infected skin ulcer below the knee, defined as "mild" by the Infectious Disease Society of America (IDSA) Guidelines, for whom, in the Investigator's judgment, topical or oral antimicrobial therapy is appropriate (Mild infection severity: The presence of ≥ 2 manifestations of inflammation (purulence or erythema, pain, tenderness, warmth or induration) but any cellulitis/erythema extends ≤ 2 cm around the ulcer, and the infection is limited to the skin or superficial subcutaneous tissue, with no other local complications or acute, systemic illness).
• Has had an x-ray of the infected area within the 2 days immediately preceding or at Visit 1 (Baseline/Randomization) that is negative for osteomyelitis.
• Meets the certain minimal laboratory criteria
• Has an ankle-brachial index (ABI) ≥ 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 ≥ 40 mm Hg on the limb with the target ulcer.)
• If female, is nonpregnant (negative pregnancy tests 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 1 of the following medically-acceptable methods of birth control and agrees to continue with the regimen throughout the duration of the study:
• Oral, implantable or injectable contraceptives for 3 consecutive months before the Baseline/Randomization Visit
• Total abstinence from sexual intercourse (≥ 1 complete menstrual cycle before the Baseline/Randomization Visit)
• Intrauterine device (IUD)
• Double barrier method (condoms, sponge, diaphragm or vaginal ring with spermicidal jellies or cream)
• 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 an infecting pathogen known to be intermediate or resistant in vitro to levofloxacin. Patients enrolled into the study presumptively will be discontinued if their cultured organism is intermediate or resistant to levofloxacin.
• Has a target ulcer with a wound size \> 5 × 5 cm.
• Has gangrenous tissue of the affected limb that cannot be removed with a single debridement.
• 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 \[Day 1\]).
• Has documented osteomyelitis.
• 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.
• Is undergoing dialysis (renal or peritoneal) or has 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)

Chesapeake Research Group LLC

Pasadena, Maryland, 21122, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Levofloxacin

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Ofloxacin; 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
• Restrictive Agreement: No

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: January 4, 2008
• First Posted: January 15, 2008
• Study Start: December 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: May 31, 2022
• Results First Posted: May 31, 2022

Record last verified: 2022-05

Locations

US (1)