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Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With a Mild Infection of a Foot Ulcer

NCT00593567 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-05-31

Study results available
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Summary

The purpose of this study is to determine whether the gentamicin-collagen sponge when combined with standard of daily wound care is safe and effective in treating mildly infected skin ulcers compared to treatment with an oral antibiotic (levofloxacin) and standard daily wound care.

Conditions

  • Diabetic Foot Ulcer

Interventions

DRUG

gentamicin-collagen sponge

Inserted daily into open ulcer

DRUG

Levofloxacin

750mg oral levofloxacin daily

Sponsors & Collaborators

  • Premier Research Group plc

    collaborator UNKNOWN

  • Innocoll

    lead INDUSTRY

Principal Investigators

  • David Prior · Innocoll

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • United States

Study Locations

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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 NCT00593567 on ClinicalTrials.gov