NCT00545298

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Nitric BioTherapeutics, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Venous Ulcers

Interventions

Type	Name	Description
DRUG	Nitric Oxide - same dose 6 wks	200ppm, 8hrs / day for 6 weeks NO gas in nitrogen delivered to a patch over the wound
DRUG	Nitric Oxide modified treatment	200ppm, 8hrs/day for 1 week, followed by 25ppm 8hrs/day for 5 weeks Gas is delivered to a patch over the wound

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2007-10-17
• Last updated: 2012-11-19
• Results posted: 2012-11-19

Locations

1 site across 1 country: United States