At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 70 enrolled
Drug / intervention
gentamicin-collagen sponge +1 moredrug
Likely dose
Levofloxacin 750mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study to Investigate the Safety and Efficacy of a Topical Gentamicin-Collagen Sponge Compared to Levofloxacin in Diabetic Patients With a Mild Infection of a Lower Extremity Skin Ulcer
In Brief
A Phase 2 clinical trial evaluating gentamicin-collagen sponge and Levofloxacin for Diabetic Foot Ulcer. Completed, enrolled 70 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Foot Ulcer
CountriesUnited States
CollaboratorsPremier Research
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2007
First PostedJan 2008
Primary CompletionMay 2009
TodayJul 2026
First PostedJan 15, 2008
Enrollment StartDec 1, 2007
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 18.5 years ago
Interventions
gentamicin-collagen spongedrug
Inserted daily into open ulcer
Levofloxacindrug
750mg oral levofloxacin daily