A Phase 2 interventional study of Nitric Oxide - same dose 6 wks and Nitric Oxide modified treatment in Venous Ulcers, sponsored by Nitric BioTherapeutics, Inc. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-11-19.
Sponsored by Nitric BioTherapeutics, Inc · Phase 2, Interventional, and Treatment
This study will test the safety and efficacy of nitric oxide gas in the treatment of venous leg ulcers
Prospective, single center. Controlled study of a moisture retentive wound dressing and sustained compression with 6 weeks of 8 hour daily nitric oxide treatments.
378 studies on the registry are indexed under Varicose Ulcer; 80 are open to participants now.
This study's enrollment of 4 is below the median of 64 across 325 interventional studies indexed under Varicose Ulcer.
Browse Varicose Ulcer studies →Nitric BioTherapeutics, Inc is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The above is a partial list of the inclusion and exclusion criteria; however, other inclusion and exclusion criteria may apply.
Standard of care - dressings and sustained compression only
200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound
Drug: Nitric Oxide - same dose 6 wks
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
Drug: Nitric Oxide modified treatment
200ppm, 8hrs / day for 6 weeks NO gas in nitrogen delivered to a patch over the wound
200ppm, 8hrs/day for 1 week, followed by 25ppm 8hrs/day for 5 weeks Gas is delivered to a patch over the wound
Wound Healing
% Re-epithelialization
Time frame: Week 20
Adverse Events (AEs) and Serious Adverse Events (SAEs)
All reported adverse events, related or unrelated to the study drug.
Time frame: up to 24 weeks
single site, 4 subjects recruited starting in October, 2007 with the last vist on August 28, 2008
| Milestone | A - Standard of Care (Control) | B - Same Treatment for 6 Weeks | C - Modified Treatment, 5 Wks Lower Dose |
|---|---|---|---|
| Started | 2 | 1 | 1 |
| Completed | 0 | 1 | 0 |
| Not completed | 2 | 0 | 1 |
| Withdrew: Issues with standard of care | 2 | 0 | 1 |
% Re-epithelialization
| % re-epithelialization | B - Same Treatment for 6 Weeks | A - Standard of Care (Control) | C - Modified Treatment, 5 Wks Lower Dose |
|---|---|---|---|
| Wound Healing | 10 | — | — |
All reported adverse events, related or unrelated to the study drug.
| number of events | A - Standard of Care (Control) | B - Same Treatment for 6 Weeks | C - Modified Treatment, 5 Wks Lower Dose |
|---|---|---|---|
| AEs | 4 | 4 | 7 |
| SAEs | 0 | 0 | 0 |
Collected over up to 24 weeks. Non-serious events are listed at a 4% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| A - Standard of Care (Control) | — | 0/2 (0%) | 2/2 (100%) |
| B Same Treatment for 6 Weeks | — | 0/1 (0%) | 1/1 (100%) |
| C - Modified Treatment, 5 Wks Lower Dose | — | 0/1 (0%) | 1/1 (100%) |
| Event | A - Standard of Care (Control) | B Same Treatment for 6 Weeks | C - Modified Treatment, 5 Wks Lower Dose |
|---|---|---|---|
| Pain/ Compression WrapSkin and subcutaneous tissue disorders | 1/2 | 1/1 | 0/1 |
| ParonychiaSkin and subcutaneous tissue disorders | 0/2 | 1/1 | 0/1 |
| epistaxisGeneral disorders | 0/2 | 1/1 | 0/1 |
| blister formationSkin and subcutaneous tissue disorders | 0/2 | 0/1 | 1/1 |
| deterioration of the woundSkin and subcutaneous tissue disorders | 1/2 | 0/1 | 1/1 |
| viral illnessRespiratory, thoracic and mediastinal disorders | 0/2 | 0/1 | 1/1 |
| upper respiratory infectionRespiratory, thoracic and mediastinal disorders | 1/2 | 0/1 | 1/1 |
| wound infectionSkin and subcutaneous tissue disorders | 0/2 | 0/1 | 1/1 |
| Age, Categorical(Participants) | A - Standard of Care (Control) | B Same Treatment for 6 Weeks | C - Modified Treatment, 5 Wks Lower Dose | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 1 | 1 | 2 |
| >=65 years | 2 | 0 | 0 | 2 |
| Age Continuous(years) | A - Standard of Care (Control) | B Same Treatment for 6 Weeks | C - Modified Treatment, 5 Wks Lower Dose | Total |
|---|---|---|---|---|
| Mean | 76 ± 4 | 60 ± 0 | 65 ± 0 | 69 ± 5 |
| Sex: Female, Male(Participants) | A - Standard of Care (Control) | B Same Treatment for 6 Weeks | C - Modified Treatment, 5 Wks Lower Dose | Total |
|---|---|---|---|---|
| Female | 0 | 1 | 1 | 2 |
| Male | 2 | 0 | 0 | 2 |
| Region of Enrollment(participants) | A - Standard of Care (Control) | B Same Treatment for 6 Weeks | C - Modified Treatment, 5 Wks Lower Dose | Total |
|---|---|---|---|---|
| United States | 2 | 1 | 1 | 4 |
This study is terminated, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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Nitric BioTherapeutics, Inc