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

PHASE4CompletedINTERVENTIONAL
Enrollment

88

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

June 30, 2016

Study Completion Date

June 30, 2016

Conditions
Diabetic Foot Ulcer
Interventions
DRUG

Garamycin Sponge (Gentamicin-Collagen sponge)

Gentamicin Collagen Sponge: 5 × 5 cm in size containing Type I bovine collagen and 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)

DRUG

Systemic Antibiotic

"Antibiotics options per protocol:~Levofloxacin PO 750 mg q.24h or 500 mg q.12h Levofloxacin IV 750 mg q.24h or 500 mg q.12h Amoxicillin/clavulanate PO 500/125 mg q.12h. or q.8h Amoxicillin/clavulanate IV 1000/200 mg q.12h or q.8h Clindamycin PO 300 mg or 450 mg q.6h Clindamycin IV 600 mg q.8h or q.6h Linezolid PO 600 mg q.12h Linezolid IV 600 mg q.12h Metronidazole PO 400 mg or 500 mg q.8h or 500 mg q.6h Metronidazole IV 500 mg q.8h or q.6h Aztreonam IV 1 g or 2 g q.12h or q.8h Piperacillin/tazobactam IV 3000/375 mg q.6h or 4000/500 mg q.8h"

Trial Locations (1)

Unknown

Geneva University Hospitals, Geneva

All Listed Sponsors
lead

University Hospital, Geneva

OTHER

NCT01951768 - Efficacy and Safety of Garamycin® Sponge in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection | Biotech Hunter | Biotech Hunter