Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers
OneStep-2
A Randomized, Double-Blind, Multicenter, Superiority, Placebo-Controlled Phase 3 Study of Pexiganan Cream 0.8% Applied Twice Daily for 14 Days in the Treatment of Adults With Mild Infections of Diabetic Foot Ulcers
1 other identifier
interventional
200
1 country
39
Brief Summary
The purpose of this study is to establish the clinical superiority and the safety of topical pexiganan cream 0.8% plus standard local wound care as compared to placebo cream plus standard local wound care, in the treatment of mildly infected diabetic foot ulcers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2014
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2012
CompletedFirst Posted
Study publicly available on registry
May 9, 2012
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedResults Posted
Study results publicly available
June 14, 2017
CompletedJune 14, 2017
April 1, 2017
2.1 years
May 7, 2012
April 14, 2017
May 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Clinical Response
The numbers of participants with Clinical Response, defined as resolution of infection, are reported.
28 days
Secondary Outcomes (2)
Number of Participants With Microbiological Response
28 days
Number of Participants With Treatment-Emergent Adverse Events (TEAE)
28 days
Study Arms (2)
Topical placebo control
PLACEBO COMPARATORDrug: Topical placebo cream
Topical pexiganan cream 0.8%
EXPERIMENTALDrug: Topical pexiganan cream 0.8%
Interventions
14 days of treatment
Eligibility Criteria
You may qualify if:
- Diabetes mellitus.
- Male or female at least 18 years old.
- 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.
- Subject is to be treated on an outpatient basis.
- 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.
- Localized mild infection of the ulcer.
- The diagnosis of mild infection must be confirmed immediately following debridement at Baseline.
- 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.
You may not qualify if:
- IDSA-defined moderate infection, including cellulitis extending \> 2 cm; lymphangitis; spread beneath the fascia; deep tissue abscess; gangrene; muscle, joint, or bone involvement.
- IDSA-defined severe infection, including systemic toxicity or metabolic instability.
- Infected diabetic foot ulcer that is associated with local wound complications such as prosthetic materials or protruding surgical hardware.
- \> 1 infected foot ulcer.
- Subject is currently receiving topical antimicrobial treatment for a localized infection of the study ulcer and whose infection is improving in response to treatment.
- Subject has received a systemic antibiotic within 48 hours prior to Screening.
- Concurrent or expected to require systemic antimicrobials during the study period for any infection, including diabetic foot ulcer.
- Bone or joint involvement is suspected based on clinical examination or plain X-ray.
- Clinically significant peripheral arterial disease requiring vascular intervention.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Unknown Facility
Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Jonesboro, Arkansas, United States
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Castro Valley, California, United States
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Davis, California, United States
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Los Angeles, California, United States
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Napa, California, United States
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San Francisco, California, United States
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Santa Rosa, California, United States
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Sylmar, California, United States
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Vacaville, California, United States
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Norwalk, Connecticut, United States
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Coral Gables, Florida, United States
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Doral, Florida, United States
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Hialeah, Florida, United States
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Homestead, Florida, United States
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Jacksonville, Florida, United States
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Largo, Florida, United States
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Miami, Florida, United States
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Miami Lakes, Florida, United States
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Miami Shores, Florida, United States
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Pinellas Park, Florida, United States
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Evans, Georgia, United States
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North Chicago, Illinois, United States
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Hutchinson, Kansas, United States
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New Orleans, Louisiana, United States
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Mineola, New York, United States
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Charlotte, North Carolina, United States
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Wilmington, North Carolina, United States
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Duncansville, Pennsylvania, United States
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York, Pennsylvania, United States
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Columbia, South Carolina, United States
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El Paso, Texas, United States
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Fort Worth, Texas, United States
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Lewisville, Texas, United States
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Salt Lake City, Utah, United States
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St. George, Utah, United States
Unknown Facility
Roanoke, Virginia, United States
Unknown Facility
Richland, Washington, United States
Related Publications (1)
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.
PMID: 36781451DERIVED
MeSH Terms
Interventions
Results Point of Contact
- Title
- Robert J DeLuccia
- Organization
- Dipexium Pharmaceuticals, Inc
Study Officials
- STUDY DIRECTOR
Michael H. Silverman, MD
Biostrategics Consulting Ltd
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2012
First Posted
May 9, 2012
Study Start
June 1, 2014
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
June 14, 2017
Results First Posted
June 14, 2017
Record last verified: 2017-04