A Phase 2 interventional study of Nitric Oxide in Chronic Ulcer of Lower Extremity, sponsored by Loma Linda University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-26.
Sponsored by Loma Linda University · Phase 2, Interventional, and Treatment
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.
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:
298 studies on the registry are indexed under Leg Ulcer; 43 are open to participants now.
This study's enrollment of 7 is below the median of 60 across 241 interventional studies indexed under Leg Ulcer.
Browse Leg Ulcer studies →Loma Linda University is the lead sponsor of 297 studies on the registry; 48 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 23 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Topically applied Nitric Oxide for 8 hours daily for 2 weeks.
Drug: Nitric Oxide
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
The Primary Endpoint is the Eradication of the Bio-burden as Measured by a Reduction in Culture Growth to ≤ +2.
Time frame: at 28 days post enrollment
The Secondary Endpoint Measure is a Reduction on Wound Size.
reduction in bioburden as assessed by number of cfu's per cm2 on culture
Time frame: 28 days post enrollment
| Milestone | Topically Applied Nitric Oxide |
|---|---|
| Started | 7 |
| Completed | 7 |
| Not completed | 0 |
No measurements were reported for this outcome.
reduction in bioburden as assessed by number of cfu's per cm2 on culture
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 | — | 0/7 (0%) | 0/7 (0%) |
| Age, Categorical(Participants) | Group 1 |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 3 |
| >=65 years | 4 |
| Sex: Female, Male(Participants) | Group 1 |
|---|---|
| Female | 5 |
| Male | 2 |
| Region of Enrollment(participants) | Group 1 |
|---|---|
| United States | 7 |
| Evidence of a colonized wound on the lower extremity.(participants) | Group 1 |
|---|---|
| >=65 years | 4 |
| 18 to 65 years | 3 |
This study is terminated, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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Loma Linda University