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

January 7, 2008 updated by: Oculus Innovative Sciences, Inc.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

65

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85710
    • 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
    • Colorado
      • Denver, Colorado, United States, 80220
    • Connecticut
      • New Haven, Connecticut, United States, 06515
    • Florida
      • Boca Raton, Florida, United States, 33486
      • Spring Hill, Florida, United States, 34609
    • Indiana
      • Evansville, Indiana, United States, 47714
    • Kentucky
      • Louisville, Kentucky, United States, 40222
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
    • Pennsylvania
      • Harrisburgh, Pennsylvania, United States, 17112
      • Hazleton, Pennsylvania, United States, 18201
      • Pittsburgh, Pennsylvania, United States, 15224
    • Utah
      • Salt Lake City, Utah, United States, 54102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Topical Dermacyn
Drug: Topical Dermacyn
Topical Dermacyn once a day for 10 Days
Other Names:
  • 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:
  • Levaquin®
  • Dermacyn™ Wound Care
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:
  • Saline Solution
  • Levoquin®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Visit 3 (Day 10); Visit 4 (Day 24)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
Visit 2 (Day 3); Visit 3 (Day 10)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oculus Innovative Sciences, Inc.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

August 14, 2007

First Submitted That Met QC Criteria

August 14, 2007

First Posted (Estimate)

August 16, 2007

Study Record Updates

Last Update Posted (Estimate)

January 14, 2008

Last Update Submitted That Met QC Criteria

January 7, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OIS-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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