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

This study has been completed.
Sponsor:
Collaborator:
Premier Research Group plc
Information provided by (Responsible Party):
Innocoll Technologies
ClinicalTrials.gov Identifier:
NCT00593567
First received: January 4, 2008
Last updated: March 22, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Diabetic Foot Ulcer
Drug: gentamicin-collagen sponge
Drug: Levofloxacin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study to Investigate the Safety and Efficacy of a Topical Gentamicin-Collagen Sponge Compared to Levofloxacin in Diabetic Patients With a Mild Infection of a Lower Extremity Skin Ulcer

Resource links provided by NLM:


Further study details as provided by Innocoll Technologies:

Primary Outcome Measures:
  • Percent of patients with a clinical outcome of "clinical cure" in each treatment group [ Time Frame: Final Study Visit (Day 21 [or 28 or 35]) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percent of patients with a clinical outcome of "clinical cure" in each treatment group [ Time Frame: Each time point (Day 1, 3, 7 [14 and 21 if necessary]) ] [ Designated as safety issue: Yes ]
  • Percent of patients with pathogen eradication in each treatment group [ Time Frame: At each timepoint (Day 1, 3, 7 [14 and 21 if necessary] and Day 21 [or 28 or 35]) ] [ Designated as safety issue: Yes ]
  • Reduction (absolute and percent decrease, compared to Baseline) in total wound surface area in each treatment group [ Time Frame: At each timepoint (Day 1, 3, 7 [14 and 21 if necessary] and Day 21 [or 28 or 35]) ] [ Designated as safety issue: No ]
  • Time to clinical cure [ Time Frame: Actual time assessed (Day 1, 3, 7 [14 and 21 if necessary] and Day 21 [or 28 or 35]) ] [ Designated as safety issue: Yes ]
  • Time to pathogen eradication [ Time Frame: Actual time assessed (Day 1, 3, 7 [14 and 21 if necessary] and Day 21 [or 28 or 35]) ] [ Designated as safety issue: Yes ]
  • Percent of patients with a clinical response, defined as those with a clinical outcome of "clinical cure" or "clinical improvement" in each treatment group [ Time Frame: (Day 1, 3, 7 [14 and 21 if necessary] and Day 21 [or 28 or 35]) ] [ Designated as safety issue: Yes ]

Enrollment: 70
Study Start Date: December 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Daily topical gentamicin sponge and standard daily wound care
Drug: gentamicin-collagen sponge
Inserted daily into open ulcer
Active Comparator: B
Daily oral levofloxacin 750 mg and standard daily wound care
Drug: Levofloxacin
750mg oral levofloxacin daily

Detailed Description:

Infected skin ulcers in patients 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. Diabetic ulcers can be caused by a patient's inability to sense pain or warmth as well as peripheral vascular disease, which causes diminished blood flow to the foot. Early aggressive treatment is necessary to treat infection and prevent the need for amputation.

Gentamicin is an antibiotic that is effective in treating certain kinds of infection. Collagen is a protein that is found in all mammals. The gentamicin-collagen sponge is a thin flat sponge made out of collagen that comes from cow tendons and containing gentamicin. When applied to an open ulcer, the collagen breaks down and the gentamicin is released into the ulcer, but very little is absorbed into the blood stream. The high levels of gentamicin in the open infected ulcer may help treat the infection.

In this study, all subjects will be given the necessary supplies and taught how to take care of their foot ulcer. Subjects who are randomly assigned to the gentamicin-collagen sponge treatment group will place a gentamicin-collagen sponge on their ulcer during daily wound care. Subjects who are randomly assigned to the oral levofloxacin treatment group will also perform daily wound care, but they will not be given the gentamicin-collagen sponge. Instead they will be given the antibiotic, levofloxacin to take by mouth during the treatment period.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00593567

Locations
United States, Maryland
Chesapeake Research Group LLC
Pasadena, Maryland, United States, 21122
Sponsors and Collaborators
Innocoll Technologies
Premier Research Group plc
Investigators
Study Director: David Prior Innocoll Technologies
  More Information

No publications provided

Responsible Party: Innocoll Technologies
ClinicalTrials.gov Identifier: NCT00593567     History of Changes
Other Study ID Numbers: INN-TOP-001
Study First Received: January 4, 2008
Last Updated: March 22, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Innocoll Technologies:
Diabetic Foot Ulcer

Additional relevant MeSH terms:
Diabetic Foot
Ulcer
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Pathologic Processes
Foot Diseases
Gentamicins
Levofloxacin
Ofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 22, 2014