Status:
TERMINATED
Topical Nitric Oxide Trial in Chronic Non-Healing Wounds
Lead Sponsor:
Loma Linda University
Collaborating Sponsors:
Nitric BioTherapeutics, Inc
Conditions:
Chronic Ulcer of Lower Extremity
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 s...
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: * ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00823095
Start Date
December 1 2005
End Date
October 1 2008
Last Update
February 26 2016
Active Locations (1)
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1
Loma Linda University Medical Center
Loma Linda, California, United States, 92354