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Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers (OneStep-1)

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. Identifier: NCT01590758
Recruitment Status : Completed
First Posted : May 3, 2012
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Information provided by (Responsible Party):
Dipexium Pharmaceuticals, Inc.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 189 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 : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Topical placebo control 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%
14 days of treatment
Other Name: MSI-78

Other: Standard wound care
14 days of treatment

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 Success [ Time Frame: 28 days ]
    The numbers of participants with Microbiological Response, defined as eradication of all initial pathogens, are reported.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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.
  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.

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 identifier (NCT number): NCT01590758

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United States, Alabama
Birmingham, Alabama, United States
United States, Arizona
Glendale, Arizona, United States
Mesa, Arizona, United States
Tucson, Arizona, United States
United States, Arkansas
Jonesboro, Arkansas, United States
United States, California
Bakersfield, California, United States
Fair Oaks, California, United States
Fresno, California, United States
Los Angeles, California, United States
United States, Florida
Boynton Beach, Florida, United States
Hialeah, Florida, United States
Miami, Florida, United States
North Miami Beach, Florida, United States
South Miami, Florida, United States
United States, Kentucky
Lexington, Kentucky, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Massachusetts
Cambridge, Massachusetts, United States
United States, Montana
Missoula, Montana, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New Jersey
Emerson, New Jersey, United States
United States, North Carolina
Greenville, North Carolina, United States
United States, Ohio
Toledo, Ohio, United States
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Aiken, South Carolina, United States
United States, Texas
Baytown, Texas, United States
Dallas, Texas, United States
McAllen, Texas, United States
McKinney, Texas, United States
San Antonio, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
Sponsors and Collaborators
Dipexium Pharmaceuticals, Inc.
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Study Director: Michael H. Silverman, MD BioStrategics Consulting Ltd
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Responsible Party: Dipexium Pharmaceuticals, Inc. Identifier: NCT01590758    
Other Study ID Numbers: DPX-305
First Posted: May 3, 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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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
Anti-Bacterial Agents
Anti-Infective Agents