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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01594762
First Posted: May 9, 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.
  Purpose
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 Intervention Phase
Diabetic Foot Infection Drug: Topical pexiganan cream 0.8% Drug: Topical placebo cream Other: Standard wound care Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Dipexium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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:
  • 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.

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


Enrollment: 200
Study Start Date: June 2014
Study Completion Date: July 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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


  Show 39 Study Locations
Sponsors and Collaborators
Dipexium Pharmaceuticals, Inc.
Investigators
Study Director: Michael H. Silverman, MD Biostrategics Consulting Ltd
  More Information

Responsible Party: Dipexium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01594762     History of Changes
Other Study ID Numbers: DPX-306
First Submitted: May 7, 2012
First Posted: May 9, 2012
Results First Submitted: April 14, 2017
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:
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