Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: July 2016

Interventions

  • Drug: Topical pexiganan cream 0.8%
    • 14 days of treatment
  • Drug: Topical placebo cream
    • 14 days of treatment
  • Other: Standard wound care
    • 14 days of treatment

Arms, Groups and Cohorts

  • Placebo Comparator: Topical placebo control
    • Drug: Topical placebo cream
  • Experimental: Topical pexiganan cream 0.8%
    • Drug: Topical pexiganan cream 0.8%

Clinical Trial Outcome Measures

Primary 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 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Dipexium Pharmaceuticals, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Michael H. Silverman, MD, Study Director, Biostrategics Consulting Ltd

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