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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oculus Innovative Sciences, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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