NCT00823095

Brief Summary

To determine the effects of topically applied ViaNOx-H for 8 hours daily for 2 weeks on the reduction of the bio-burden in biofilms on chronic non-healing wounds as recorded by measurements of wound size and wound culture.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2009

Completed
5.3 years until next milestone

Results Posted

Study results publicly available

May 5, 2014

Completed
Last Updated

February 26, 2016

Status Verified

April 1, 2014

Enrollment Period

2.8 years

First QC Date

January 13, 2009

Results QC Date

August 2, 2013

Last Update Submit

January 28, 2016

Conditions

Chronic Ulcer of Lower Extremity

Keywords

chronic cutaneous ulcersNitric Oxidetopically appliedBiofilmColonized chronic non-healing ulcers

Outcome Measures

Primary Outcomes (1)

  • The Primary Endpoint is the Eradication of the Bio-burden as Measured by a Reduction in Culture Growth to ≤ +2.

    at 28 days post enrollment

Secondary Outcomes (1)

  • The Secondary Endpoint Measure is a Reduction on Wound Size.

    28 days post enrollment

Study Arms (1)

Topically applied Nitric Oxide

EXPERIMENTAL

Topically applied Nitric Oxide for 8 hours daily for 2 weeks.

Drug: Nitric Oxide

Interventions

Nitric OxideDRUG

Topically applied gaseous nitric oxide at 8 to 10 parts per million, for 8 hours each night for 14 nights.

Also known as: ViaNOx-H, gaseous nitric oxide, gNO
Topically applied Nitric Oxide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a chronic (\> 8 weeks duration) colonized cutaneous ulcer (defined as a wound containing a local margin of erythema, edema or tenderness; presence of exudates; and/or presence of a malodorous smell)in their lower extremity (below the knee) resulting from either diabetes or venous stasis disease.
  • Are 18 years of age or older.

You may not qualify if:

  • Have had a change in their topical treatment during the last 4 weeks
  • Have evidence of Clinical Infection
  • Have a transcutaneous oxygen tension \<30mmHg
  • Have evidence of the ulcer or infection extending to the underlying muscle or bone.
  • Are pregnant.
  • Are less than 18 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

MeSH Terms

Interventions

Nitric Oxide

Intervention Hierarchy (Ancestors)

Reactive Nitrogen SpeciesFree RadicalsInorganic ChemicalsNitrogen OxidesNitrogen CompoundsOxidesOxygen CompoundsOrganic Chemicals

Limitations and Caveats

No data available for this study due to dissolution of company contracted to perform study analysis.

Results Point of Contact

Title
Deborah Dodge
Organization
Loma Linda University Medical Center
ddodge@llu.edu
(909) 558-4000

Study Officials

  • Takkin Lo, MD, MPH

    Loma Linda University Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2009

First Posted

January 15, 2009

Study Start

December 1, 2005

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

February 26, 2016

Results First Posted

May 5, 2014

Record last verified: 2014-04

Locations

US(1)