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NCT00563433 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Abeona Therapeutics.

Completed
Registry status
Phase 3
Development phase
342
Enrollment target

NCT00563433: Completed Phase 3 study, sponsored by Abeona Therapeutics.

NCT00563433 is a Phase 3 study that has completed, run by Abeona Therapeutics. The registered enrollment target is 342 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00563433, a Phase 3 study, has completed, sponsored by Abeona Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
342 participants
Enrollment target

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.

Primary Outcome

Measure will be a comparison of the reduction in clinical signs and symptoms of infection between MSI-78 topical therapy and conventional oral antibiotic therapy

Interventions

  • DRUG ofloxacin
  • DRUG MSI-78

Trial Details

FieldValue
Enrollment Target 342 participants
Start Date 1994-08
Est. Completion 1996-07
Phase Phase 3
Abeona Therapeutics

8 total trials

What the finished NCT00563433 record still lists

NCT00563433 is an interventional study that assigns participants to a tested intervention. The registered 342 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower).

The record links to 0 conditions, and to 2 interventions - of which ofloxacin is the first listed.

NCT00563433 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00563433 about?

NCT00563433 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 NCT00563433?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 342 participants. The study started on 1994-08. Estimated completion is 1996-07.

What interventions are being tested in trial NCT00563433?

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

Who is sponsoring clinical trial NCT00563433?

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

How this trial's enrollment target compares

Where NCT00563433's enrollment target sits among peer trials

342 1053rd of 2000 higher than 948 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00563433, the US trial registry maintained by the National Library of Medicine. NCT00563433 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.