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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: Completed Phase 3 study, sponsored by Innocoll.
NCT02427802 is a Phase 3 study that has completed, run by Innocoll. The registered enrollment target is 612 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary efficacy variable is the percent of patients with a clinical outcome of clinical cure (Resolution of all clinical signs and symptoms of infection) at F/U visit 1
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 |
What the finished NCT02427802 record still lists
NCT02427802 is an interventional study that assigns participants to a tested intervention. The registered 612 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 (21% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02427802 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02427802's enrollment target sits among peer trials
612 598th of 2000 higher than 1,401 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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