drugset / Trial / NCT01951768

Efficacy and Safety of Garamycin® Sponge in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection

NCT01951768 ↗

Phase 4 Completed 88 enrolled University Hospital, Geneva
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine whether Garamycin Sponge (Gentamicin-Collagen sponge) in combination with antibiotics is safe and effective in treating moderate and severe diabetic foot infections.

Timeline

Start
2013-09
Primary completion
2016-06
Completion
2016-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Gentamicin Small molecule 50 mg Topical
Comparator Amoxicillin/clavulanate Unknown 125 mg —
Comparator Amoxicillin/clavulanate Unknown 200 mg —
Comparator Amoxicillin/clavulanate Unknown 500 mg —
Comparator Amoxicillin/clavulanate Unknown 1000 mg —
Comparator Aztreonam Small molecule 1 g —
Comparator Aztreonam Small molecule 2 g —
Comparator Clindamycin Unknown 300 mg —
Comparator Clindamycin Unknown 450 mg —
Comparator Clindamycin Unknown 600 mg —
Comparator Levofloxacin Small molecule 500 mg —
Comparator Levofloxacin Small molecule 750 mg —
Comparator Linezolid Other / unclassified 600 mg —
Comparator Metronidazole Small molecule 400 mg —
Comparator Metronidazole Small molecule 500 mg —
Comparator Piperacillin/tazobactam Unknown 375 mg —
Comparator Piperacillin/tazobactam Unknown 500 mg —
Comparator Piperacillin/tazobactam Unknown 3000 mg —
Comparator Piperacillin/tazobactam Unknown 4000 mg —

Indications