Pilot Study of the Safety and Clinical Efficacy of Topical Dermacyn™ Wound Care to Treat Mild Diabetic Foot Infections
This study has been completed.
Sponsor:
Oculus Innovative Sciences, Inc.
Information provided by:
Oculus Innovative Sciences, Inc.
ClinicalTrials.gov Identifier:
NCT00516958
First received: August 14, 2007
Last updated: January 7, 2008
Last verified: January 2008
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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 2 |
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 |
Resource links provided by NLM:
Further study details as provided by Oculus Innovative Sciences, Inc.:
Primary Outcome Measures:
- To compare the rates of clinical success (cure + improvement) of Topical Dermacyn™ vs. Oral Levofloxacin vs. Combined therapy, in patients with mild diabetic foot infections in non ischemic ulcers [ Time Frame: Visit 3 (Day 10); Visit 4 (Day 24) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To compare the treatment groups with respect to microbiological outcome. Incidence of adverse events and other safety outcomes [ Time Frame: Visit 2 (Day 3); Visit 3 (Day 10) ] [ Designated as safety issue: No ]
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 |
Criteria
Inclusion Criteria:
A patient must meet all of the following inclusion criteria to be enrolled in the study:
- Males and females > 18 years of age with diabetes mellitus (type 1 or type 2, controlled).
- Presence of infected, non-ischemic diabetic foot ulcer that involves skin and deeper soft tissue as stratified by IDSA guidelines and the UTC / 1B.
- Foot infections that are anticipated to be cured in 10 days of oral antibiotic therapy.
- Foot ulcers located in the plantar, dorsal or malleolar areas.
- Ulcers 1- 9 cm2 in size.
- An accessible infection site for culture.
- ABI by Doppler ≥ 0.8 or TcPO2 ≥ 30 mmHg.
- Palpable pulse on the study foot (either dorsalis or posterior tibial artery).
- Willing and able to give informed consent.
- Willing to comply with the requirements for participation in the study.
Exclusion Criteria:
Patients are excluded if they meet any of the following criteria at the time of randomization:
- Previous antibiotic treatment received for more than 24 hours within 72 hours of study.
- Necrotizing fasciitis, deep abscesses in the soft tissue, sinus tracts, gas gangrene, or infected burns.
- Superinfected eczema or other chronic inflammatory skin conditions (i.e., atopic dermatitis).
- The patient´s ulcer is located on the stump of an amputated extremity.
- The patient's ulcer is due to a non-diabetic etiology.
- Infections complicated by the presence of prosthetic materials.
- Osteomyelitis
- Females of childbearing potential who are unable to take adequate contraceptive precautions or are breastfeeding.
- Known to have liver disease, with total bilirubin > 5 times the Upper Limit of Normal (ULN); known to have neutropenia (absolute neutrophil count <500 cells/mm3).
- Hypersensitivity to chlorine or quinolones.
- Need for any additional concomitant systemic antibacterial agent other than the study drug(s).
- Concomitant glucocorticoid doses (> 5mg prednisone a day or equivalent).
- Adjuvant therapy with hyperbaric oxygen or topical formulations containing growth factors, antimicrobials or enzymatic debriders.
- A history of diseases of immune function (HIV, chronic granulomatous disease).
- Any medical condition that, in the investigator´s opinion, will require dose modification of Levofloxacin to less than 750 mg a day.
- Has received an investigational agent ≤1 month prior to the baseline evaluation.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00516958
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 |
Sponsors and Collaborators
Oculus Innovative Sciences, Inc.
Investigators
Study Director: | Andres Gutierrez, M.D., Ph.D. | Oculus Innovative Sciences |
More Information
Publications:
Keywords provided by Oculus Innovative Sciences, Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 17, 2012
Publications:
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 |
Keywords provided by Oculus Innovative Sciences, Inc.:
diabetic ulcer infection topical wound |
Additional relevant MeSH terms:
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 |
ClinicalTrials.gov processed this record on October 17, 2012