Safety and Efficacy of Gaseous Nitric Oxide on Venous Stasis Leg Ulcers

Stopped early · Phase 2

Conditions studied: Venous Ulcers

In brief

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.

Key facts

Study ID

NCT00613808

Run by

Nitric BioTherapeutics, Inc

People needed

6

Starts

2008-02-01

Expected to finish

2009-05-01

Last updated by the study team

2012-01-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Diabetic Foot & Wound Center — Denver, Colorado, United States
• Alamo Podiatry Associates — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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