- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00658957
Prevention of Infection Using a Topical Gentamicin-Collagen Sponge in Diabetic Patients With An Uninfected Foot Ulcer
A Phase II, Randomized, Parallel, Double-blind, Placebo-controlled Study to Assess Prevention of Infection Using a Topical Gentamicin-Collagen Sponge in Diabetic Patients With Uninfected Lower Extremity Skin Ulcers
Study Overview
Status
Conditions
Intervention / Treatment
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. 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 prevent infection and ultimately 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 their foot ulcer. Subjects will be randomly assigned to receive either the gentamicin-collagen sponge or a plain collagen sponge. The sponge will be applied into the ulcer twice a week during the treatment period.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Maryland
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Pasadena, Maryland, United States, 21122
- Chesapeake Foot and Ankle Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 skin ulcer below the knee, defined as "uninfected" by the Infectious Disease Society of America Guidelines (Wound lacking purulence or any manifestations of inflammation).
- Has had an x-ray of the affected area within the 2 days immediately preceding or at Visit 1 (Baseline/Randomization) that is negative for osteomyelitis.
- 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.)
- Meets certain minimal laboratory criteria.
- 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 at least 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 study:
Oral, implantable or injectable contraceptives for 3 consecutive months before the Baseline/Randomization Visit.
Total abstinence from sexual intercourse (minimum of 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 Posttreatment Evaluation 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 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 > 5 × 5 cm.
- Has gangrene or infection of the affected limb.
- 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 history of myasthenia gravis or other neurological condition where gentamicin use is contraindicated as determined by the Investigator.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
Daily standard wound care and topical application of the gentamicin-collagen sponge twice weekly
|
5 × 5 cm sponge
Other Names:
|
Placebo Comparator: B
Daily standard wound care and topical application of the placebo sponge twice weekly
|
5 × 5 cm sponge
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The percentage of patients who remain free of signs and symptoms of infection until the end of the study
Time Frame: Up to 3 months
|
Up to 3 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time (days) to complete wound closure
Time Frame: Actual time
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Actual time
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Time (days) to presence of ≥ 1 of the signs and symptoms of infection
Time Frame: Actual time
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Actual time
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Absolute and percent decrease in total wound surface area
Time Frame: End of Study
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End of Study
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Pathogen burden in patients who discontinue because of infection
Time Frame: Throughout study period
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Throughout study period
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Treatment emergent Adverse Events
Time Frame: Throughout study period
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Throughout study period
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Leg Ulcer
- Skin Ulcer
- Diabetes Complications
- Diabetes Mellitus
- Diabetic Neuropathies
- Foot Diseases
- Diabetic Foot
- Foot Ulcer
- Ulcer
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Protein Synthesis Inhibitors
- Gentamicins
Other Study ID Numbers
- INN-TOP-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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