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NCT00563394 · ClinicalTrials.gov registry record · Phase 3

MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers

A Phase 3 study of Diabetic Foot Ulcers, sponsored by Abeona Therapeutics.

Completed
Registry status
Phase 3
Development phase
584
Enrollment target
1
Study location

NCT00563394 is a Phase 3 study of Diabetic Foot Ulcers that has completed, run by Abeona Therapeutics. The registered enrollment target is 584 participants, above the 186-participant average among 12 other Diabetic Foot Ulcers trials with a reported enrollment target (214% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT00563394, a Phase 3 study of Diabetic Foot Ulcers, has completed, sponsored by Abeona Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
584 participants
Enrollment target
1
Study location

Study Summary

224 adults with diabetic foot ulcers will be randomized to either magainin peptide (MSI-78) or ofloxacin (FLOXIN, Ortho-McNeil Pharmaceutical Corporation) an oral fluoroquinolone antibiotic.

Conditions Studied

Interventions

  • DRUG ofloxacin
  • DRUG MSI-78

Study Locations (1)

Washington

  • Seattle VA Medical Center - Seattle

Trial Details

FieldValue
Enrollment Target 584 participants
Start Date 1994-08
Est. Completion 1996-07
Phase Phase 3

Sponsor

Abeona Therapeutics

8 total trials

What the Registry Record Tells You About NCT00563394

The ClinicalTrials.gov registry entry for NCT00563394 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 584 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 186-participant average among 12 other Diabetic Foot Ulcers trials with a reported enrollment target (214% higher). The listed sponsor is Abeona Therapeutics, which has 8 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Diabetic Foot Ulcers appearing as the primary indexed condition, and to 2 interventions - of which ofloxacin is the first listed.

NCT00563394 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.

Frequently Asked Questions

What is clinical trial NCT00563394 about?

NCT00563394 is a clinical study titled "MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers". 224 adults with diabetic foot ulcers will be randomized to either magainin peptide (MSI-78) or ofloxacin (FLOXIN, Ortho-McNeil Pharmaceutical Corporation) an oral fluoroquinolone antibiotic.

What is the current status of trial NCT00563394?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 584 participants. The study started on 1994-08. Estimated completion is 1996-07.

What conditions does trial NCT00563394 study?

This clinical trial studies the following conditions: Diabetic Foot Ulcers.

What interventions are being tested in trial NCT00563394?

The interventions under investigation include: ofloxacin (DRUG), MSI-78 (DRUG).

Who is sponsoring clinical trial NCT00563394?

This trial is sponsored by Abeona Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00563394 being conducted?

This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.