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

Tracking Information
First Submitted Date  ICMJE April 27, 2012
First Posted Date  ICMJE May 3, 2012
Results First Submitted Date  ICMJE April 14, 2017
Results First Posted Date  ICMJE June 14, 2017
Last Update Posted Date June 14, 2017
Study Start Date  ICMJE June 2014
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2017)
Number of Participants With Clinical Response [ Time Frame: 28 days ]
The numbers of participants with Clinical Response, defined as resolution of infection, are reported.
Original Primary Outcome Measures  ICMJE
 (submitted: May 2, 2012)
Clinical Response [ Time Frame: 28 days ]
Clinical Response will be classified according to the Investigator's medical judgment as one of the following: infection resolved, infection not resolved, recurrent infection, or unevaluable.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2017)
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2012)
  • Microbiological Response [ Time Frame: 28 days ]
    Microbiological Response to therapy will be categorized as one of the following: complete microbiological response, partial microbiological response, no microbiological response, colonization, superinfection, relapse, reinfection, unevaluable, or not applicable.
  • Incidence and severity of adverse events [ Time Frame: 28 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Foot Infection
Intervention  ICMJE
  • Drug: Topical pexiganan cream 0.8%
    14 days of treatment
    Other Name: MSI-78
  • Drug: Topical placebo cream
    14 days of treatment
  • Other: Standard wound care
    14 days of treatment
Study Arms  ICMJE
  • Placebo Comparator: Topical placebo control
    Interventions:
    • Drug: Topical placebo cream
    • Other: Standard wound care
  • Experimental: Topical pexiganan cream 0.8%
    Interventions:
    • Drug: Topical pexiganan cream 0.8%
    • Other: Standard wound care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 8, 2016)
189
Original Estimated Enrollment  ICMJE
 (submitted: May 2, 2012)
180
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01590758
Other Study ID Numbers  ICMJE DPX-305
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dipexium Pharmaceuticals, Inc.
Study Sponsor  ICMJE Dipexium Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Michael H. Silverman, MD BioStrategics Consulting Ltd
PRS Account Dipexium Pharmaceuticals, Inc.
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP