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

NCT00516958 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2008-01-14

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Oculus Innovative Sciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Andres Gutierrez, M.D., Ph.D. · Oculus Innovative Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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 NCT00516958 on ClinicalTrials.gov