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

• Status: Terminated
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nitric BioTherapeutics, Inc
• Treatments: Nitric Oxide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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