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NCT00659646 · ClinicalTrials.gov registry record · Phase 2
The Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With Moderately Infected Foot Ulcers
A Phase 2 study, sponsored by Innocoll.
- Completed
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
NCT00659646: Completed Phase 2 study, sponsored by Innocoll.
NCT00659646 is a Phase 2 study that has completed, run by Innocoll. The registered enrollment target is 56 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00659646, a Phase 2 study, has completed, sponsored by Innocoll.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether the gentamicin-collagen sponge when combined with standard daily wound care and an oral antibiotic (levofloxacin) is safe and effective in treating moderately infected skin ulcers compared to treatment only with standard daily wound care and an oral antibiotic (levofloxacin).
Primary Outcome
Number of participants with a clinical cure in each treatment group at Visit 3 (Day 7). Clinical Cure is defined as positive clinical response and with pathogen eradication.
Interventions
- DRUG gentamicin-collagen sponge and levofloxacin
- DRUG Levofloxacin only
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2008-04 |
| Est. Completion | 2010-02 |
| Phase | Phase 2 |
What the finished NCT00659646 record still lists
NCT00659646 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 2 interventions - of which gentamicin-collagen sponge and levofloxacin is the first listed.
NCT00659646 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00659646 about?
NCT00659646 is a clinical study titled "The Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With Moderately Infected Foot Ulcers". The purpose of this study is to determine whether the gentamicin-collagen sponge when combined with standard daily wound care and an oral antibiotic (levofloxacin) is safe and effective in treating moderately infected skin ulcers compared to treatment only with standard daily wound care and an oral ...
What is the current status of trial NCT00659646?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2008-04. Estimated completion is 2010-02.
What interventions are being tested in trial NCT00659646?
The interventions under investigation include: gentamicin-collagen sponge and levofloxacin (DRUG), Levofloxacin only (DRUG).
Who is sponsoring clinical trial NCT00659646?
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 NCT00659646's enrollment target sits among peer trials
56 1146th of 2000 higher than 848 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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