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

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

Detailed Description
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Prospective, single center. Controlled study of a moisture retentive wound dressing and sustained compression with 6 weeks of 8 hour daily nitric oxide treatments.

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

Conditions
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Venous Ulcers

Intervention / Treatment
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* Drug: Nitric Oxide - same dose 6 wks
* Drug: Nitric Oxide modified treatment


Participation Criteria
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Eligibility Criteria
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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.

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 | |
| Experimental: B Same treatment for 6 weeks<br>200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound | Drug: Nitric Oxide - same dose 6 wks<br>* 200ppm, 8hrs / day for 6 weeks NO gas in nitrogen delivered to a patch over the wound<br>|
| Experimental: C - modified treatment, 5 wks lower dose<br>200 ppm No gas 8 hrs/day 1 wk, 20ppm 8hrs/day 5 weeks Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound | Drug: Nitric Oxide modified treatment<br>* 200ppm, 8hrs/day for 1 week, followed by 25ppm 8hrs/day for 5 weeks Gas is delivered to a patch over the wound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Healing | % Re-epithelialization | Week 20 | 
| Adverse Events (AEs) and Serious Adverse Events (SAEs) | All reported adverse events, related or unrelated to the study drug. | up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nitric Oxide, Venous Leg Ulcers