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

Phase 2

Terminated

• Conditions: Venous Ulcers
• Interventions: Drug: Nitric Oxide - same dose 6 wks; Drug: Nitric Oxide modified treatment

• Registration Number: NCT00545298
• Lead Sponsor: Nitric BioTherapeutics, Inc

Brief 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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-16
• Study First Submitted QC: 2007-10-16
• Study First Posted: 2007-10-17
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Results First Submitted: 2012-08-08
• Status Verified: 2012-10
• Results First Submitted QC: 2012-10-18
• Last Update Submitted: 2012-10-18
• Results First Posted: 2012-11-19
• Last Update Posted: 2012-11-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B Same treatment for 6 weeks	Nitric Oxide - same dose 6 wks	200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound
C - modified treatment, 5 wks lower dose	Nitric Oxide modified treatment	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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Retreat Hospital, Wound Healing Center; 🇺🇸 Richmond, Virginia, United States