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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Dipexium Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
Dipexium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01594762
First received: May 7, 2012
Last updated: October 6, 2014
Last verified: October 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:
  • Clinical Response [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Microbiological Response [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: June 2014
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: October 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01594762

Contacts
Contact: Carol A. Gibbons 866-877-7376 ext 3423 cgibbons@rpsweb.com

Locations
United States, Arizona
Recruiting
Phoenix, Arizona, United States
United States, Arkansas
Recruiting
Jonesboro, Arkansas, United States
United States, California
Recruiting
San Francisco, California, United States
Recruiting
Sylmar, California, United States
United States, Florida
Recruiting
Coral Gables, Florida, United States
Recruiting
Jacksonville, Florida, United States
Recruiting
Miami Lakes, Florida, United States
Recruiting
Miami Shores, Florida, United States
United States, Georgia
Recruiting
Evans, Georgia, United States
United States, North Carolina
Recruiting
Charlotte, North Carolina, United States
United States, Pennsylvania
Recruiting
York, Pennsylvania, United States
United States, Texas
Recruiting
Ft. Worth, Texas, United States
United States, Virginia
Recruiting
Roanoke, Virginia, United States
United States, Washington
Recruiting
Richland, Washington, United States
Sponsors and Collaborators
Dipexium Pharmaceuticals, Inc.
Investigators
Study Director: Michael H. Silverman, MD Biostrategics Consulting Ltd
  More Information

No publications provided

Responsible Party: Dipexium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01594762     History of Changes
Other Study ID Numbers: DPX-306
Study First Received: May 7, 2012
Last Updated: October 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Dipexium Pharmaceuticals, Inc.:
Diabetic Foot Ulcer Infection

Additional relevant MeSH terms:
Diabetic Foot
Communicable Diseases
Foot Ulcer
Infection
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Diabetic Neuropathies
Endocrine System Diseases
Foot Diseases
Leg Ulcer
Skin Diseases
Skin Ulcer
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014