At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 189 enrolled
Drug / intervention
Topical pexiganan cream 0.8% +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Topical pexiganan cream 0.8%, Topical placebo cream, and 1 other intervention for Diabetic Foot Infection. Completed, enrolled 189 participants across 30 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Foot Infection
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 2012
Enrollment StartJun 2014
Primary CompletionAug 2016
TodayJul 2026
First PostedMay 3, 2012
Enrollment StartJun 1, 2014
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 14.2 years ago
Interventions
Topical pexiganan cream 0.8%drug
14 days of treatment
Topical placebo creamdrug
14 days of treatment
Standard wound careother
14 days of treatment