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

This study is not yet open for participant recruitment.
Verified May 2012 by Dipexium Pharmaceuticals, LLC
Sponsor:
Information provided by (Responsible Party):
Dipexium Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT01594762
First received: May 7, 2012
Last updated: May 10, 2012
Last verified: May 2012
History of Changes
  Purpose

The purpose of this study is to establish the clinical superiority and the safety of topical pexiganan acetate cream 1% 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: Pexiganan acetate cream 1%
Drug: 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 Acetate Cream 1% Applied Twice Daily for 14 Days in the Treatment of Adults With Mild Infections of Diabetic Foot Ulcers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dipexium Pharmaceuticals, LLC:

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: October 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo control
Drug: placebo cream
 Drug: Placebo cream
14 days of treatment
Other: Standard wound care
14 days of treatment
Experimental: Pexiganan acetate cream 1%
Drug: pexiganan acetate cream 1%
 Drug: Pexiganan acetate cream 1%
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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01594762

Contacts
Contact: Micahel H. Silverman, MD 781-631-8596 msilverman@biostrategics.com

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

No publications provided

Responsible Party: Dipexium Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT01594762     History of Changes
Other Study ID Numbers: DPX-306
Study First Received: May 7, 2012
Last Updated: May 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Dipexium Pharmaceuticals, LLC:
Diabetic Foot Ulcer Infection

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

ClinicalTrials.gov processed this record on May 21, 2013