Overview

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.