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

NCT01590758 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2017-06-14

Study results available
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Summary

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.

Conditions

  • Diabetic Foot Infection

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

Sponsors & Collaborators

  • Dipexium Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael H. Silverman, MD · BioStrategics Consulting Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01590758 on ClinicalTrials.gov