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NCT00593567 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With a Mild Infection of a Foot Ulcer
A Phase 2 study, sponsored by Innocoll.
- Completed
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
NCT00593567: Completed Phase 2 study, sponsored by Innocoll.
NCT00593567 is a Phase 2 study that has completed, run by Innocoll. The registered enrollment target is 70 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00593567, a Phase 2 study, has completed, sponsored by Innocoll.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether the gentamicin-collagen sponge when combined with standard of daily wound care is safe and effective in treating mildly infected skin ulcers compared to treatment with an oral antibiotic (levofloxacin) and standard daily wound care.
Primary Outcome
Number of Participants with a clinical outcome of "clinical cure" at final visit. Clinical Cure is defined as positive clinical response and with pathogen eradication.
Interventions
- DRUG Levofloxacin
- DRUG gentamicin-collagen sponge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2007-12 |
| Est. Completion | 2009-05 |
| Phase | Phase 2 |
What the finished NCT00593567 record still lists
NCT00593567 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Levofloxacin is the first listed.
NCT00593567 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00593567 about?
NCT00593567 is a clinical study titled "Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With a Mild Infection of a Foot Ulcer". The purpose of this study is to determine whether the gentamicin-collagen sponge when combined with standard of daily wound care is safe and effective in treating mildly infected skin ulcers compared to treatment with an oral antibiotic (levofloxacin) and standard daily wound care.
What is the current status of trial NCT00593567?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2007-12. Estimated completion is 2009-05.
What interventions are being tested in trial NCT00593567?
The interventions under investigation include: Levofloxacin (DRUG), gentamicin-collagen sponge (DRUG).
Who is sponsoring clinical trial NCT00593567?
This trial is sponsored by Innocoll, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00593567's enrollment target sits among peer trials
70 937th of 2000 higher than 1,036 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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