Status:
TERMINATED
Safety and Efficacy of Gaseous Nitric Oxide on Venous Stasis Leg Ulcers
Lead Sponsor:
Nitric BioTherapeutics, Inc
Conditions:
Venous Ulcers
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether nitric oxide (NO)gas is effective in the treatment of venous ulcers of the lower leg.
Detailed Description
SUbjects were divided into two Groups - one receiving 200ppm NO gas delivered topically to the wound area for 8 hours a day for 6 weeks. The other Group (control arm) received Standard of Care (compre...
Eligibility Criteria
Inclusion
- Must have given written informed consent and HIPAA authorization
- Must be ≥ 18 years of age
- Must have a venous ulcer for 60 days or greater
- ABPI \> 0.8 and ≤ 1.2
- Must have ulcer between 3cm2 and 25cm2 in size
Exclusion
- Has an ulcer that is deemed by the Investigator to be caused primarily by a medical condition other than venous insufficiency
- BMI ≥ 35
- Has evidence of clinical infection
- Suffers from diabetes mellitus with HbA1c ≥ 8%
- Suffers from clinically significant arterial disease
- Has a known allergy to any of the compounds / drugs that are part of this protocol
- Has evidence of the ulcer and / or infection extending to the underlying muscle, tendon or bone
- Has used any investigational drug(s) within 30 days preceding randomization
- Is unable to manage self-treatment
- Is pregnant, nursing mother or a woman of child bearing potential who is not using an adequate form of contraception (or abstinence)
- Suffers from a condition which in the opinion of the Investigator would compromise the safety of the subject and / or the quality of the data
- Is using any of the prohibited concomitant medications or treatments
- Has previously participated in this study
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00613808
Start Date
February 1 2008
End Date
May 1 2009
Last Update
January 25 2012
Active Locations (2)
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1
Diabetic Foot & Wound Center
Denver, Colorado, United States, 80220
2
Alamo Podiatry Associates
San Antonio, Texas, United States, 78211