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.
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