Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers
NCT ID: NCT01594762
Last Updated: 2017-06-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
200 participants
INTERVENTIONAL
2014-06-30
2016-07-31
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
Drug: Topical placebo cream
Topical placebo cream
14 days of treatment
Standard wound care
14 days of treatment
Topical pexiganan cream 0.8%
Drug: 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, including systemic toxicity or metabolic instability.
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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Phoenix, Arizona, United States
Tucson, Arizona, United States
Jonesboro, Arkansas, United States
Castro Valley, California, United States
Davis, California, United States
Los Angeles, California, United States
Napa, California, United States
San Francisco, California, United States
Santa Rosa, California, United States
Sylmar, California, United States
Vacaville, California, United States
Norwalk, Connecticut, United States
Coral Gables, Florida, United States
Doral, Florida, United States
Hialeah, Florida, United States
Homestead, Florida, United States
Jacksonville, Florida, United States
Largo, Florida, United States
Miami, Florida, United States
Miami Lakes, Florida, United States
Miami Shores, Florida, United States
Pinellas Park, Florida, United States
Evans, Georgia, United States
North Chicago, Illinois, United States
Hutchinson, Kansas, United States
New Orleans, Louisiana, United States
Mineola, New York, United States
Charlotte, North Carolina, United States
Wilmington, North Carolina, United States
Duncansville, Pennsylvania, United States
York, Pennsylvania, United States
Columbia, South Carolina, United States
El Paso, Texas, United States
Fort Worth, Texas, United States
Lewisville, Texas, United States
Salt Lake City, Utah, United States
St. George, Utah, United States
Roanoke, Virginia, United States
Richland, Washington, United States
Countries
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References
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You Y, Liu H, Zhu Y, Zheng H. Rational design of stapled antimicrobial peptides. Amino Acids. 2023 Apr;55(4):421-442. doi: 10.1007/s00726-023-03245-w. Epub 2023 Feb 12.
Other Identifiers
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DPX-306
Identifier Type: -
Identifier Source: org_study_id
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