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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Infection
• Intervention / Treatment: Drug: Topical placebo cream; Other: Standard wound care; Drug: Topical pexiganan cream 0.8%

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States
    • Tucson, Arizona, United States
  • Arkansas
    • Jonesboro, Arkansas, United States
  • California
    • Castro Valley, California, United States
    • Davis, California, United States
    • Los Angeles, California, United States
    • Napa, California, United States
    • San Francisco, California, United States
    • Santa Rosa, California, United States
    • Sylmar, California, United States
    • Vacaville, California, United States
  • Connecticut
    • Norwalk, Connecticut, United States
  • Florida
    • Coral Gables, Florida, United States
    • Doral, Florida, United States
    • Hialeah, Florida, United States
    • Homestead, Florida, United States
    • Jacksonville, Florida, United States
    • Largo, Florida, United States
    • Miami, Florida, United States
    • Miami Lakes, Florida, United States
    • Miami Shores, Florida, United States
    • Pinellas Park, Florida, United States
  • Georgia
    • Evans, Georgia, United States
  • Illinois
    • North Chicago, Illinois, United States
  • Kansas
    • Hutchinson, Kansas, United States
  • Louisiana
    • New Orleans, Louisiana, United States
  • New York
    • Mineola, New York, United States
  • North Carolina
    • Charlotte, North Carolina, United States
    • Wilmington, North Carolina, United States
  • Pennsylvania
    • Duncansville, Pennsylvania, United States
    • York, Pennsylvania, United States
  • South Carolina
    • Columbia, South Carolina, United States
  • Texas
    • El Paso, Texas, United States
    • Fort Worth, Texas, United States
    • Lewisville, Texas, United States
  • Utah
    • Saint George, Utah, United States
    • Salt Lake City, Utah, United States
  • Virginia
    • Roanoke, Virginia, United States
  • Washington
    • Richland, Washington, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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%	Other: Standard wound care; 14 days of treatment; Drug: Topical pexiganan cream 0.8%; 14 days of treatment; Other Names: MSI-78

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Clinical Response	The numbers of participants with Clinical Response, defined as resolution of infection, are reported.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Microbiological Response	The numbers of participants with Microbiological Response, defined are eradication of all baseline pathogens, are reported.	28 days
Number of Participants With Treatment-Emergent Adverse Events (TEAE)	The number of participants with TEAEs, including Serious TEAEs, are reported	28 days

Collaborators and Investigators

• Sponsor: Dipexium Pharmaceuticals, Inc.
• Investigators: Study Director: Michael H. Silverman, MD, BioStrategics Consulting Ltd

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (ACTUAL): July 1, 2016
• Study Completion (ACTUAL): July 1, 2016

Study Registration Dates

• First Submitted: May 7, 2012
• First Submitted That Met QC Criteria: May 8, 2012
• First Posted (ESTIMATE): May 9, 2012

Study Record Updates

• Last Update Posted (ACTUAL): June 14, 2017
• Last Update Submitted That Met QC Criteria: May 19, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Diabetic Foot Ulcer Infection
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Disease Attributes; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Infections; Communicable Diseases; Anti-Infective Agents; Anti-Bacterial Agents; Pexiganan
• Other Study ID Numbers: DPX-306