NCT01590758

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: Dipexium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2014-06-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2012-05-03
• Last updated: 2017-06-14
• Results posted: 2017-06-14

Locations

30 sites across 1 country: United States