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:
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
  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:
  • Dermacyn™ Wound Care
  • Levaquin®
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®

  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:

    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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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:
Infection
Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Levofloxacin
Ofloxacin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on October 19, 2014