- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01590758
Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers (OneStep-1)
May 19, 2017 updated by: Dipexium Pharmaceuticals, Inc.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
189
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States
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Arizona
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Glendale, Arizona, United States
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Mesa, Arizona, United States
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Tucson, Arizona, United States
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Arkansas
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Jonesboro, Arkansas, United States
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California
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Bakersfield, California, United States
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Fair Oaks, California, United States
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Fresno, California, United States
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Los Angeles, California, United States
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Florida
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Boynton Beach, Florida, United States
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Hialeah, Florida, United States
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Miami, Florida, United States
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North Miami Beach, Florida, United States
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South Miami, Florida, United States
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Kentucky
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Lexington, Kentucky, United States
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Maryland
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Baltimore, Maryland, United States
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Massachusetts
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Cambridge, Massachusetts, United States
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Montana
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Missoula, Montana, United States
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Nevada
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Las Vegas, Nevada, United States
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New Jersey
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Emerson, New Jersey, United States
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North Carolina
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Greenville, North Carolina, United States
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Ohio
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Toledo, Ohio, United States
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Pennsylvania
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Pittsburgh, Pennsylvania, United States
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South Carolina
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Aiken, South Carolina, United States
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Texas
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Baytown, Texas, United States
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Dallas, Texas, United States
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McAllen, Texas, United States
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McKinney, Texas, United States
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San Antonio, Texas, United States
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Utah
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Salt Lake City, Utah, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- IDSA-defined moderate infection.
- IDSA-defined severe infection.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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PLACEBO_COMPARATOR: Topical placebo control
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14 days of treatment
14 days of treatment
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EXPERIMENTAL: Topical pexiganan cream 0.8%
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14 days of treatment
14 days of treatment
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With Clinical Response
Time Frame: 28 days
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The numbers of participants with Clinical Response, defined as resolution of infection, are reported.
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28 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With Microbiological Success
Time Frame: 28 days
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The numbers of participants with Microbiological Response, defined as eradication of all initial pathogens, are reported.
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28 days
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Number of Participants With Treatment-emergent Adverse Events (TEAE)
Time Frame: 28 days
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The numbers of participants with TEAEs, including those with Serious TEAEs, are reported
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28 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Michael H. Silverman, MD, BioStrategics Consulting Ltd
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (ACTUAL)
August 1, 2016
Study Completion (ACTUAL)
August 1, 2016
Study Registration Dates
First Submitted
April 27, 2012
First Submitted That Met QC Criteria
May 2, 2012
First Posted (ESTIMATE)
May 3, 2012
Study Record Updates
Last Update Posted (ACTUAL)
June 14, 2017
Last Update Submitted That Met QC Criteria
May 19, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Endocrine System Diseases
- Disease Attributes
- Diabetic Angiopathies
- Leg Ulcer
- Skin Ulcer
- Diabetes Complications
- Diabetes Mellitus
- Diabetic Neuropathies
- Foot Diseases
- Diabetic Foot
- Foot Ulcer
- Infections
- Communicable Diseases
- Anti-Infective Agents
- Anti-Bacterial Agents
- Pexiganan
Other Study ID Numbers
- DPX-305
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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