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Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers

NCT02447172 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 524

Last updated 2021-09-29

Study results available
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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

Interventions

DRUG

Gentamicin Collagen sponge

Up to 4 topical Gentamicin Collagen Sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)

OTHER

Placebo

Matching placebo sponge

Sponsors & Collaborators

  • Innocoll

    lead INDUSTRY

Principal Investigators

  • Nigel Jones · Vice President, Global Clinical Operations, Innocoll Pharmaceutical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Germany
  • Hungary
  • Ireland
  • Italy
  • Netherlands
  • Poland
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02447172 on ClinicalTrials.gov