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

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Investigation of Topical Application of Gaseous Nitric Oxide on Safety and Efficacy in Venous Stasis Ulcers of the Lower Extremities

Conditions
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Venous Ulcers

Intervention / Treatment
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* Drug: Nitric Oxide 200ppm Group B


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: A - Standard of Care (control)<br>Standard of care - dressings and sustained compression only for the two week screening period and then for 20 weeks thereafter | |
| Active Comparator: B Same treatment for 6 weeks, 200ppm NO gas<br>Subjects were treated by topical application of 200ppm Nitric Oxide gas delivered to the wound area for 8 hours per day for 6 weeks | Drug: Nitric Oxide 200ppm Group B<br>* 200 ppm, 8hrs / day for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of daily application of Nitric Oxide on rate of closure in venous ulcers |  | 24 weeks or wound closure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life |  | 24 weeks or wound closure | 
| Incidence of adverse events |  | 24 weeks or wound closure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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venous, leg, ulcer