NCT00516958

Pilot Study of the Safety and Clinical Efficacy of Topical Dermacyn™ Wound Care to Treat Mild Diabetic Foot Infections

An Open Label, Three Arm, Pilot Study of the Safety and Clinical Efficacy of Topical Dermacyn™ Wound Care vs. Oral Levofloxacin vs. Combined Therapy for Mild Diabetic Foot Infections

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Oculus Innovative Sciences, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare the rates of clinical success of Topical Dermacyn™ vs. Oral Levofloxacin vs. Combined therapy, in subjects with mild diabetic foot infections in non-ischemic ulcers.

Conditions

• Foot Ulcer, Diabetic

Interventions

Type	Name	Description
DRUG	Topical Dermacyn	Topical Dermacyn once a day for 10 Days
DRUG	Topical Dermacyn and Levofloxacin	Topical Dermacyn once a day and levofloxacin 750 mg PO per day; both for 10 days
DRUG	Topical Saline and Levofloxacin	Topical saline once a day and levofloxacin 750 mg PO daily, both for 10 days

Timeline

• Start date: 2007-05-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2007-08-16
• Last updated: 2008-01-14

Locations

16 sites across 1 country: United States