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

• Status: Terminated
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will test the safety and efficacy of nitric oxide gas in the treatment of venous leg ulcers

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

Details

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

Criteria

Inclusion Criteria:

• Must have a venous stasis ulcer between the knee and the ankle.

• Ulcer duration must be 60 days or greater

Exclusion Criteria:

• Has an ulcer that is deemed by the Investigator to be caused primarily by a medical condition other than venous insufficiency

• Suffers from diabetes mellitus with HbA1c ≥ 8%

• Suffers from clinically significant arterial disease

• Is pregnant, a nursing mother or a woman of child bearing potential who is not using an adequate form of contraception (or abstinent)

The above is a partial list of the inclusion and exclusion criteria; however, other inclusion and exclusion criteria may apply.