Back to resultsTopical Nitric Oxide Trial in Chronic Non-Healing Wounds
Primary Purpose
Chronic Ulcer of Lower Extremity
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nitric Oxide
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Ulcer of Lower Extremity focused on measuring chronic cutaneous ulcers, Nitric Oxide, topically applied, Biofilm, Colonized chronic non-healing ulcers
Eligibility Criteria
Inclusion Criteria:
- Have a chronic (> 8 weeks duration) colonized cutaneous ulcer (defined as a wound containing a local margin of erythema, edema or tenderness; presence of exudates; and/or presence of a malodorous smell)in their lower extremity (below the knee) resulting from either diabetes or venous stasis disease.
- Are 18 years of age or older.
Exclusion Criteria:
- Have had a change in their topical treatment during the last 4 weeks
- Have evidence of Clinical Infection
- Have a transcutaneous oxygen tension <30mmHg
- Have evidence of the ulcer or infection extending to the underlying muscle or bone.
- Are pregnant.
- Are less than 18 years of age.
Sites / Locations
- Loma Linda University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Topically applied Nitric Oxide
Arm Description
Topically applied Nitric Oxide for 8 hours daily for 2 weeks.
Outcomes
Primary Outcome Measures
The Primary Endpoint is the Eradication of the Bio-burden as Measured by a Reduction in Culture Growth to ≤ +2.
Secondary Outcome Measures
The Secondary Endpoint Measure is a Reduction on Wound Size.
reduction in bioburden as assessed by number of cfu's per cm2 on culture
Full Information
NCT ID
NCT00823095
First Posted
January 13, 2009
Last Updated
January 28, 2016
Sponsor
Loma Linda University
Collaborators
Nitric BioTherapeutics, Inc
1. Study Identification
Unique Protocol Identification Number
NCT00823095
Brief Title
Topical Nitric Oxide Trial in Chronic Non-Healing Wounds
Official Title
The Observational Effects of the Topical Application of ViaNOx-H (Gaseous Nitric Oxide) on the Bio-Burden in Chronic Non-Healing Colonized Ulcers of the Lower Extremities
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Terminated
Why Stopped
Subject recuitment halted and won't resume; subjects are no longer being treated.
Study Start Date
December 2005 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University
Collaborators
Nitric BioTherapeutics, Inc
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To determine the effects of topically applied ViaNOx-H for 8 hours daily for 2 weeks on the reduction of the bio-burden in biofilms on chronic non-healing wounds as recorded by measurements of wound size and wound culture.
Detailed Description
The primary goal of this study is to determine the effects of topically applied gaseous nitric oxide on the bio-burden of chronic non-healing wounds of the lower extremities. Reports will include:
Comparisons of the demographics and diagnoses of those patients treated with ViaNOx-H.
Tabulation as to the organisms found and the bio-burden as measured by counts (0 to +4).
Tabulation of the number and types of adverse events during ViaNOx-H treatment.
Comparisons of the response of different organisms to ViaNOx-H treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Ulcer of Lower Extremity
Keywords
chronic cutaneous ulcers, Nitric Oxide, topically applied, Biofilm, Colonized chronic non-healing ulcers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Topically applied Nitric Oxide
Arm Type
Experimental
Arm Description
Topically applied Nitric Oxide for 8 hours daily for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
Nitric Oxide
Other Intervention Name(s)
ViaNOx-H, gaseous nitric oxide, gNO
Intervention Description
Topically applied gaseous nitric oxide at 8 to 10 parts per million, for 8 hours each night for 14 nights.
Primary Outcome Measure Information:
Title
The Primary Endpoint is the Eradication of the Bio-burden as Measured by a Reduction in Culture Growth to ≤ +2.
Time Frame
at 28 days post enrollment
Secondary Outcome Measure Information:
Title
The Secondary Endpoint Measure is a Reduction on Wound Size.
Description
reduction in bioburden as assessed by number of cfu's per cm2 on culture
Time Frame
28 days post enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have a chronic (> 8 weeks duration) colonized cutaneous ulcer (defined as a wound containing a local margin of erythema, edema or tenderness; presence of exudates; and/or presence of a malodorous smell)in their lower extremity (below the knee) resulting from either diabetes or venous stasis disease.
Are 18 years of age or older.
Exclusion Criteria:
Have had a change in their topical treatment during the last 4 weeks
Have evidence of Clinical Infection
Have a transcutaneous oxygen tension <30mmHg
Have evidence of the ulcer or infection extending to the underlying muscle or bone.
Are pregnant.
Are less than 18 years of age.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takkin Lo, MD, MPH
Organizational Affiliation
Loma Linda University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Topical Nitric Oxide Trial in Chronic Non-Healing Wounds
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