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

Venous Ulcers Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00613808
Study type Interventional
Source Nitric BioTherapeutics, Inc
Contact
Status Terminated
Phase Phase 2
Start date February 2008
Completion date May 2009
View Details
See also
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Terminated NCT00545298 - Safety and Efficacy of Gaseous Nitric Oxide on Venous Stasis Leg Ulcers Phase 2
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Completed NCT02034396 - Clinical Implications of Genetic Variations of Venous Stasis Ulceration N/A
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