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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01590758
First Posted: May 3, 2012
Last Update Posted: June 14, 2017
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.
Information provided by (Responsible Party):
Dipexium Pharmaceuticals, Inc.
April 27, 2012
May 3, 2012
April 14, 2017
June 14, 2017
June 14, 2017
June 2014
August 2016   (Final data collection date for primary outcome measure)
Number of Participants With Clinical Response [ Time Frame: 28 days ]
The numbers of participants with Clinical Response, defined as resolution of infection, are reported.
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.
Complete list of historical versions of study NCT01590758 on ClinicalTrials.gov Archive Site
  • 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
  • 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 ]
Not Provided
Not Provided
 
Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Diabetic Foot Infection
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
189
August 2016
August 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01590758
DPX-305
Yes
Not Provided
Not Provided
Dipexium Pharmaceuticals, Inc.
Dipexium Pharmaceuticals, Inc.
Not Provided
Study Director: Michael H. Silverman, MD BioStrategics Consulting Ltd
Dipexium Pharmaceuticals, Inc.
April 2017

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