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NCT02447172 · 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 of Infection and Foot Ulcer, Diabetic, sponsored by Innocoll.
- Completed
- Registry status
- Phase 3
- Development phase
- 524
- Enrollment target
- 20
- Study locations
NCT02447172: Completed Phase 3 study of Infection and Foot Ulcer, Diabetic, sponsored by Innocoll.
NCT02447172 is a Phase 3 study of Infection and Foot Ulcer, Diabetic that has completed, run by Innocoll. The registered enrollment target is 524 participants, below the 714-participant average among 41 other Infection trials with a reported enrollment target (27% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02447172, a Phase 3 study of Infection and Foot Ulcer, Diabetic, has completed, sponsored by Innocoll.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 524 participants
- Enrollment target
- 20
- Study locations
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
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Gentamicin Collagen sponge
Study Locations (20)
Other
- - Vienna
- - Vienna
- - Brussels
- - Edegem
- - Kortrijk
- - Liége
- - Pellenberg
- - Brno
- - Pardubice
- - Prague
- - Prague
- - Prague
- - Prague
- - Třinec
- - Zlín
Alabama
- - Anniston
Nevada
- - Las Vegas
New South Wales
- - Cowra
Queensland
- - Spring Hill
Styria
- - Graz
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 524 participants |
| Start Date | 2015-06 |
| Est. Completion | 2016-09 |
| Phase | Phase 3 |
What the finished NCT02447172 record still lists
NCT02447172 is an interventional study that assigns participants to a tested intervention. The registered 524 participants enrollment target is mid-sized for trials with a published cap, below the 714-participant average among 41 other Infection trials with a reported enrollment target (27% lower).
The record links to 2 conditions, with Infection appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02447172 names 20 study sites across 6 states, led by Other, Alabama, Nevada.
Frequently Asked Questions
What is clinical trial NCT02447172 about?
NCT02447172 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 NCT02447172?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 524 participants. The study started on 2015-06. Estimated completion is 2016-09.
What conditions does trial NCT02447172 study?
This clinical trial studies the following conditions: Infection, Foot Ulcer, Diabetic.
What interventions are being tested in trial NCT02447172?
The interventions under investigation include: Placebo (OTHER), Gentamicin Collagen sponge (DRUG).
Who is sponsoring clinical trial NCT02447172?
This trial is sponsored by Innocoll, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02447172 being conducted?
This trial has 20 study locations across Alabama, Nevada, New South Wales, Queensland, Styria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02447172's enrollment target sits among peer trials
524 9th of 41 higher than 33 of 41 other Infection trials
participants (enrollment target), bucketed by value
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