Completed PHASE3 INTERVENTIONAL 2-arm NCT01590758

Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers (OneStep-1)

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

Sponsor: Dipexium Pharmaceuticals, Inc.

Conditions Diabetic Foot Infection

Interventions Standard wound care Topical pexiganan cream 0.8% Topical placebo cream

Updated 7 times since 2017 Last updated: May 19, 2017 Started: Jun 30, 2014 Primary completion: Aug 31, 2016 Completion: Aug 31, 2016

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01590758, this PHASE3 trial focuses on Diabetic Foot Infection and remains completed. Sponsored by Dipexium Pharmaceuticals, Inc., it has been updated 7 times since 2014, reflecting limited change activity. This study is part of the global effort to build evidence for infectious disease interventions.

Status Flow

Change History

7 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Jul 2017 — Jun 2018 [monthly]

Completed PHASE3

▶ Show 2 earlier versions

Feb 2017 — Jul 2017 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Jun 2014

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Dipexium Pharmaceuticals, Inc.

Data source: Dipexium Pharmaceuticals, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aiken, United States , Bakersfield, United States , Baltimore, United States , Baytown, United States , Birmingham, United States , Boynton Beach, United States , Cambridge, United States , Dallas, United States , Emerson, United States , Fair Oaks, United States and 20 more locations