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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2007

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Topical Dermacyn
• Active Comparator: 2
  • Topical Dermacyn and levofloxacin
• Active Comparator: 3
  • Topical saline and levofloxacin

Primary 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)
    Safety Issue?: No

Secondary 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)
    Safety Issue?: No

Inclusion Criteria:

• A patient must meet all of the following inclusion criteria to be enrolled in the study:
• 1. Males and females > 18 years of age with diabetes mellitus (type 1 or type 2, controlled).
• 2. Presence of infected, non-ischemic diabetic foot ulcer that involves skin and deeper soft tissue as stratified by IDSA guidelines and the UTC / 1B.
• 3. Foot infections that are anticipated to be cured in 10 days of oral antibiotic therapy.
• 4. Foot ulcers located in the plantar, dorsal or malleolar areas.
• 5. Ulcers 1- 9 cm2 in size.
• 6. An accessible infection site for culture.
• 7. ABI by Doppler ≥ 0.8 or TcPO2 ≥ 30 mmHg.
• 8. Palpable pulse on the study foot (either dorsalis or posterior tibial artery).
• 9. Willing and able to give informed consent.
• 10. 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:
• 1. Previous antibiotic treatment received for more than 24 hours within 72 hours of study.
• 2. Necrotizing fasciitis, deep abscesses in the soft tissue, sinus tracts, gas gangrene, or infected burns.
• 3. Superinfected eczema or other chronic inflammatory skin conditions (i.e., atopic dermatitis).
• 4. The patient´s ulcer is located on the stump of an amputated extremity.
• 5. The patient's ulcer is due to a non-diabetic etiology.
• 6. Infections complicated by the presence of prosthetic materials.
• 7. Osteomyelitis
• 8. Females of childbearing potential who are unable to take adequate contraceptive precautions or are breastfeeding.
• 9. 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).
• 10. Hypersensitivity to chlorine or quinolones.
• 11. Need for any additional concomitant systemic antibacterial agent other than the study drug(s).
• 12. Concomitant glucocorticoid doses (> 5mg prednisone a day or equivalent).
• 13. Adjuvant therapy with hyperbaric oxygen or topical formulations containing growth factors, antimicrobials or enzymatic debriders.
• 14. A history of diseases of immune function (HIV, chronic granulomatous disease).
• 15. Any medical condition that, in the investigator´s opinion, will require dose modification of Levofloxacin to less than 750 mg a day.
• 16. Has received an investigational agent ≤1 month prior to the baseline evaluation.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Oculus Innovative Sciences, Inc.

Overall Clinical Trial Officials and Contacts

Andres Gutierrez, M.D., Ph.D. Study Director Oculus Innovative Sciences  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00516958

Study ID Number: OIS-005

ClinicalTrials.gov Identifier: NCT00516958

Health Authority: United States: Food and Drug Administration