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

NCT00545298 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2012-11-19

Study results available
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Summary

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

Conditions

  • Venous Ulcers

Interventions

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

Sponsors & Collaborators

  • Nitric BioTherapeutics, Inc

    lead INDUSTRY

Principal Investigators

  • Joseph V Boykin, MD · HCA Retreat Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00545298 on ClinicalTrials.gov