Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers
NCT ID: NCT01590758
Last Updated: 2017-06-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
189 participants
INTERVENTIONAL
2014-06-30
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Topical placebo control
Topical placebo cream
14 days of treatment
Standard wound care
14 days of treatment
Topical pexiganan cream 0.8%
Topical pexiganan cream 0.8%
14 days of treatment
Standard wound care
14 days of treatment
Interventions
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Topical pexiganan cream 0.8%
14 days of treatment
Topical placebo cream
14 days of treatment
Standard wound care
14 days of treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Male or female at least 18 years old.
3. Subject must agree to adhere to all protocol procedures and return for all scheduled visits, and must be willing and able to provide written informed consent.
4. Subject is to be treated on an outpatient basis.
5. Full thickness ulcer or a partial thickness ulcer on the foot distal to the malleoli with a surface area ≥ 1 cm2 after the wound has undergone appropriate debridement.
6. Localized mild infection of the ulcer.
7. The diagnosis of mild infection must be confirmed immediately following debridement at Baseline.
8. Subject must have plain radiographs taken within 2 days prior to entry showing no evidence of bony abnormalities consistent with osteomyelitis, or gas compatible with tissue crepitus, in the affected foot.
Exclusion Criteria
2. IDSA-defined severe infection.
3. Infected diabetic foot ulcer that is associated with local wound complications such as prosthetic materials or protruding surgical hardware.
4. \> 1 infected foot ulcer.
5. Subject is currently receiving topical antimicrobial treatment for a localized infection of the study ulcer and whose infection is improving in response to treatment.
6. Subject has received a systemic antibiotic within 48 hours prior to Screening.
7. Concurrent or expected to require systemic antimicrobials during the study period for any infection, including diabetic foot ulcer.
8. Bone or joint involvement is suspected based on clinical examination or plain X-ray.
9. Clinically significant peripheral arterial disease requiring vascular intervention.
10. Subject is expected to be unable to care for the ulcer or return for all scheduled visits because of hospitalization, vacation, disability, etc. during the study period, or is unable to safely monitor the infection status at home.
18 Years
ALL
No
Sponsors
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Dipexium Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Michael H. Silverman, MD
Role: STUDY_DIRECTOR
BioStrategics Consulting Ltd
Locations
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Birmingham, Alabama, United States
Glendale, Arizona, United States
Mesa, Arizona, United States
Tucson, Arizona, United States
Jonesboro, Arkansas, United States
Bakersfield, California, United States
Fair Oaks, California, United States
Fresno, California, United States
Los Angeles, California, United States
Boynton Beach, Florida, United States
Hialeah, Florida, United States
Miami, Florida, United States
North Miami Beach, Florida, United States
South Miami, Florida, United States
Lexington, Kentucky, United States
Baltimore, Maryland, United States
Cambridge, Massachusetts, United States
Missoula, Montana, United States
Las Vegas, Nevada, United States
Emerson, New Jersey, United States
Greenville, North Carolina, United States
Toledo, Ohio, United States
Pittsburgh, Pennsylvania, United States
Aiken, South Carolina, United States
Baytown, Texas, United States
Dallas, Texas, United States
McAllen, Texas, United States
McKinney, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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DPX-305
Identifier Type: -
Identifier Source: org_study_id
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