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

Phase 2

Terminated

• Conditions: Venous Ulcers
• Interventions: Drug: Nitric Oxide 200ppm Group B

• Registration Number: NCT00613808
• Lead Sponsor: Nitric BioTherapeutics, Inc

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 (compression) for 22 weeks.

Study Timeline

• Study First Submitted: 2008-01-30
• Study First Submitted QC: 2008-01-30
• Study Start: 2008-02
• Study First Posted: 2008-02-13
• Primary Completion: 2008-11
• Study Completion: 2009-05
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-24
• Last Update Posted: 2012-01-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B Same treatment for 6 weeks, 200ppm NO gas	Nitric Oxide 200ppm Group B	Subjects were treated by topical application of 200ppm Nitric Oxide gas delivered to the wound area for 8 hours per day for 6 weeks

Primary Outcome Measures

Name	Time	Method
Effect of daily application of Nitric Oxide on rate of closure in venous ulcers	24 weeks or wound closure

Secondary Outcome Measures

Name	Time	Method
Change in quality of life	24 weeks or wound closure
Incidence of adverse events	24 weeks or wound closure

Trial Locations

Locations (2)

Diabetic Foot & Wound Center; 🇺🇸 Denver, Colorado, United States

Alamo Podiatry Associates; 🇺🇸 San Antonio, Texas, United States