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Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers (OneStep-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01594762
Recruitment Status : Completed
First Posted : May 9, 2012
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Dipexium Pharmaceuticals, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Infection Drug: Topical pexiganan cream 0.8% Drug: Topical placebo cream Other: Standard wound care Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Topical placebo control
Drug: Topical placebo cream
 Drug: Topical placebo cream
14 days of treatment

Other: Standard wound care
14 days of treatment
Experimental: Topical pexiganan cream 0.8%
Drug: Topical pexiganan cream 0.8%
 Drug: Topical pexiganan cream 0.8%
14 days of treatment
Other Name: MSI-78

Other: Standard wound care
14 days of treatment


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Clinical Response [ Time Frame: 28 days ]
    The numbers of participants with Clinical Response, defined as resolution of infection, are reported.


Secondary Outcome Measures :
  1. Number of Participants With Microbiological Response [ Time Frame: 28 days ]
    The numbers of participants with Microbiological Response, defined are eradication of all baseline pathogens, are reported.

  2. Number of Participants With Treatment-Emergent Adverse Events (TEAE) [ Time Frame: 28 days ]
    The number of participants with TEAEs, including Serious TEAEs, are reported


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diabetes mellitus.
  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:

  1. IDSA-defined moderate infection, including cellulitis extending > 2 cm; lymphangitis; spread beneath the fascia; deep tissue abscess; gangrene; muscle, joint, or bone involvement.
  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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01594762


Locations
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United States, Arizona
Phoenix, Arizona, United States
Tucson, Arizona, United States
United States, Arkansas
Jonesboro, Arkansas, United States
United States, California
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
United States, Connecticut
Norwalk, Connecticut, United States
United States, Florida
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 Lakes, Florida, United States
Miami Shores, Florida, United States
Miami, Florida, United States
Pinellas Park, Florida, United States
United States, Georgia
Evans, Georgia, United States
United States, Illinois
North Chicago, Illinois, United States
United States, Kansas
Hutchinson, Kansas, United States
United States, Louisiana
New Orleans, Louisiana, United States
United States, New York
Mineola, New York, United States
United States, North Carolina
Charlotte, North Carolina, United States
Wilmington, North Carolina, United States
United States, Pennsylvania
Duncansville, Pennsylvania, United States
York, Pennsylvania, United States
United States, South Carolina
Columbia, South Carolina, United States
United States, Texas
El Paso, Texas, United States
Fort Worth, Texas, United States
Lewisville, Texas, United States
United States, Utah
Saint George, Utah, United States
Salt Lake City, Utah, United States
United States, Virginia
Roanoke, Virginia, United States
United States, Washington
Richland, Washington, United States
Sponsors and Collaborators
Dipexium Pharmaceuticals, Inc.
Investigators
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Study Director: Michael H. Silverman, MD Biostrategics Consulting Ltd
More Information
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Responsible Party: Dipexium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01594762    
Other Study ID Numbers: DPX-306
First Posted: May 9, 2012    Key Record Dates
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017
Last Verified: April 2017
Keywords provided by Dipexium Pharmaceuticals, Inc.:
Diabetic Foot Ulcer Infection
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
 Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Pexiganan
Anti-Bacterial Agents
Anti-Infective Agents