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| Sponsor: | Oculus Innovative Sciences, Inc. |
|---|---|
| Information provided by: | Oculus Innovative Sciences, Inc. |
| ClinicalTrials.gov Identifier: | NCT00516958 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Foot Ulcer, Diabetic |
Drug: Topical Dermacyn Drug: Topical Dermacyn and Levofloxacin Drug: Topical Saline and Levofloxacin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
| Estimated Enrollment: | 65 |
| Study Start Date: | May 2007 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Topical Dermacyn
|
Drug: Topical Dermacyn
Topical Dermacyn once a day for 10 Days
Other Name: Dermacyn™ Wound Care
|
|
Active Comparator: 2
Topical Dermacyn and levofloxacin
|
Drug: Topical Dermacyn and Levofloxacin
Topical Dermacyn once a day and levofloxacin 750 mg PO per day; both for 10 days
Other Names:
|
|
Active Comparator: 3
Topical saline and levofloxacin
|
Drug: Topical Saline and Levofloxacin
Topical saline once a day and levofloxacin 750 mg PO daily, both for 10 days
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A patient must meet all of the following inclusion criteria to be enrolled in the study:
Exclusion Criteria:
Patients are excluded if they meet any of the following criteria at the time of randomization:
Contacts and Locations| United States, Arizona | |
| Tucson, Arizona, United States, 85710 | |
| United States, California | |
| La Jolla, California, United States, 92037 | |
| Los Angeles, California, United States, 90063-2326 | |
| San Diego, California, United States, 92103-8896 | |
| Santa Rosa, California, United States, 34669 | |
| United States, Colorado | |
| Denver, Colorado, United States, 80220 | |
| United States, Connecticut | |
| New Haven, Connecticut, United States, 06515 | |
| United States, Florida | |
| Boca Raton, Florida, United States, 33486 | |
| Spring Hill, Florida, United States, 34609 | |
| United States, Indiana | |
| Evansville, Indiana, United States, 47714 | |
| United States, Kentucky | |
| Louisville, Kentucky, United States, 40222 | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Pennsylvania | |
| Harrisburgh, Pennsylvania, United States, 17112 | |
| Hazleton, Pennsylvania, United States, 18201 | |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| United States, Utah | |
| Salt Lake City, Utah, United States, 54102 | |
| Study Director: | Andres Gutierrez, M.D., Ph.D. | Oculus Innovative Sciences |
More Information
| Responsible Party: | Andres Gutierrez, M.D., Ph.D., Oculus Innovative Sciences, Inc. |
| ClinicalTrials.gov Identifier: | NCT00516958 History of Changes |
| Other Study ID Numbers: | OIS-005 |
| Study First Received: | August 14, 2007 |
| Last Updated: | January 7, 2008 |
| Health Authority: | United States: Food and Drug Administration |
|
diabetic ulcer infection topical wound |
|
Ulcer Foot Ulcer Diabetic Foot Pathologic Processes Foot Diseases Skin Diseases Leg Ulcer Skin Ulcer Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus |
Endocrine System Diseases Diabetic Neuropathies Ofloxacin Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Urinary Renal Agents |