Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2026-01-08 @ 3:42 PM
Study NCT ID:
NCT00823095
Status:
TERMINATED
Last Update Posted:
2016-02-26
First Post:
2009-01-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Topical Nitric Oxide Trial in Chronic Non-Healing Wounds
Sponsor:
Loma Linda University
Organization:
Study Overview
Official Title:
The Observational Effects of the Topical Application of ViaNOx-H (Gaseous Nitric Oxide) on the Bio-Burden in Chronic Non-Healing Colonized Ulcers of the Lower Extremities
Status:
TERMINATED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Subject recuitment halted and won't resume; subjects are no longer being treated.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
The primary goal of this study is to determine the effects of topically applied gaseous nitric oxide on the bio-burden of chronic non-healing wounds of the lower extremities. Reports will include:
* Comparisons of the demographics and diagnoses of those patients treated with ViaNOx-H.
* Tabulation as to the organisms found and the bio-burden as measured by counts (0 to +4).
* Tabulation of the number and types of adverse events during ViaNOx-H treatment.
* Comparisons of the response of different organisms to ViaNOx-H treatment.
* Comparisons of the demographics and diagnoses of those patients treated with ViaNOx-H.
* Tabulation as to the organisms found and the bio-burden as measured by counts (0 to +4).
* Tabulation of the number and types of adverse events during ViaNOx-H treatment.
* Comparisons of the response of different organisms to ViaNOx-H treatment.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: