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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: Completed Phase 3 study of Diabetic Foot Ulcers, sponsored by Abeona Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
a comparison of the reduction in clinical signs and symptoms of infection between MSI-78 topical therapy and conventional oral antibiotic therapy
Conditions Studied
Interventions
- DRUG ofloxacin
- DRUG MSI-78
Study Locations (1)
Washington
- Seattle VA Medical Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 584 participants |
| Start Date | 1994-08 |
| Est. Completion | 1996-07 |
| Phase | Phase 3 |
What the finished NCT00563394 record still lists
NCT00563394 is an interventional study that assigns participants to a tested intervention. The registered 584 participants enrollment target is mid-sized for trials with a published cap, above the 186-participant average among 12 other Diabetic Foot Ulcers trials with a reported enrollment target (214% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Diabetic Foot Ulcers
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00563394's enrollment target sits among peer trials
584 2nd of 12 the highest of 12 other Diabetic Foot Ulcers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Foot Ulcers 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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