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NCT02427802 · ClinicalTrials.gov registry record · Phase 3
Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers
A Phase 3 study, sponsored by Innocoll.
- Completed
- Registry status
- Phase 3
- Development phase
- 612
- Enrollment target
NCT02427802 is a Phase 3 study that has completed, run by Innocoll. The registered enrollment target is 612 participants.
The verdict
NCT02427802, a Phase 3 study, has completed, sponsored by Innocoll.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 612 participants
- Enrollment target
Study Summary
This is a phase 3, randomized, controlled, blinded, multicenter study conducted in 3 parallel cohorts of diabetic patients with at least 1 infected foot ulcer. Patients will be randomized to receive 1 of 3 study treatments; systemic antibiotic therapy and standard ulcer care with either (A) daily application of a gentamicin-sponge, (B) daily application of a placebo-sponge or (C) no-sponge, in the ratio 2:1:1. Patients will be treated for approximately 28 days and return to the clinic weekly for safety and efficacy assessments. After completing treatment, patients will return to the clinic for scheduled follow-up visits approximately 10, 30, 60 and 90 days after treatment is stopped.
Interventions
- OTHER Placebo
- DRUG Gentamicin collagen sponge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 612 participants |
| Start Date | 2015-05 |
| Est. Completion | 2016-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02427802
The ClinicalTrials.gov registry entry for NCT02427802 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 612 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Innocoll, which has 19 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02427802 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02427802 about?
NCT02427802 is a clinical study titled "Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers". This is a phase 3, randomized, controlled, blinded, multicenter study conducted in 3 parallel cohorts of diabetic patients with at least 1 infected foot ulcer. Patients will be randomized to receive 1 of 3 study treatments; systemic antibiotic therapy and standard ulcer care with either (A) daily ap...
What is the current status of trial NCT02427802?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 612 participants. The study started on 2015-05. Estimated completion is 2016-10.
What interventions are being tested in trial NCT02427802?
The interventions under investigation include: Placebo (OTHER), Gentamicin collagen sponge (DRUG).
Who is sponsoring clinical trial NCT02427802?
This trial is sponsored by Innocoll, which has 19 total clinical trials registered on ClinicalTrials.gov.
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