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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 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.

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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.

Conditions Studied

Infection Foot Ulcer, Diabetic

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

FieldValue
Enrollment Target 524 participants
Start Date 2015-06
Est. Completion 2016-09
Phase Phase 3

Sponsor

Innocoll

19 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02447172

The ClinicalTrials.gov registry entry for NCT02447172 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 524 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 714-participant average among 41 other Infection trials with a reported enrollment target (27% lower). The listed sponsor is Innocoll, which has 19 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.