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 April 2016 by Dipexium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Dipexium Pharmaceuticals, Inc. Identifier:
First received: May 7, 2012
Last updated: April 15, 2016
Last verified: April 2016

May 7, 2012
April 15, 2016
June 2014
May 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01594762 on Archive Site
  • 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 ]
Same as current
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
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
    Drug: Topical placebo cream
    • Drug: Topical placebo cream
    • Other: Standard wound care
  • Experimental: Topical pexiganan cream 0.8%
    Drug: Topical pexiganan cream 0.8%
    • 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 Identifier (NCT Number) in Medline.
June 2016
May 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, 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.
18 Years and older
Contact: Carol A. Gibbons 215-591-1051
United States
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 2016

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