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Strategic direction of the sponsor changed
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A - Standard of Care (control) | No Intervention | Standard of care - dressings and sustained compression only | |
| B Same treatment for 6 weeks | Experimental | 200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound |
|
| C - modified treatment, 5 wks lower dose | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitric Oxide - same dose 6 wks | Drug | 200ppm, 8hrs / day for 6 weeks NO gas in nitrogen delivered to a patch over the wound |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wound Healing | % Re-epithelialization | Week 20 |
| Adverse Events (AEs) and Serious Adverse Events (SAEs) | All reported adverse events, related or unrelated to the study drug. | up to 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
The above is a partial list of the inclusion and exclusion criteria; however, other inclusion and exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Joseph V Boykin, MD | HCA Retreat Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retreat Hospital, Wound Healing Center | Richmond | Virginia | 23220 | United States |
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single site, 4 subjects recruited starting in October, 2007 with the last vist on August 28, 2008
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| ID | Title | Description |
|---|---|---|
| FG000 | A - Standard of Care (Control) | Standard of care - dressings and sustained compression only |
| FG001 | B - Same Treatment for 6 Weeks | 200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound |
| FG002 | C - Modified Treatment, 5 Wks Lower Dose | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | A - Standard of Care (Control) | Standard of care - dressings and sustained compression only |
| BG001 | B Same Treatment for 6 Weeks | 200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Wound Healing | % Re-epithelialization | Per protocol. Only one subject met the 20 week time point. All other subjects withdrew early from the study and did not reach the Week 20 time point | Posted | Number | % re-epithelialization | Week 20 |
|
up to 24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A - Standard of Care (Control) | Standard of care - dressings and sustained compression only |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain/ Compression Wrap | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
Early termination due to small number of subjects enrolled
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frank J. McCaney, CEO Sponsor | Nitric BioTherapeutics Inc | 215-788-6200 | fmccaney@nbtherapeutics.com |
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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| Nitric Oxide modified treatment | Drug | 200ppm, 8hrs/day for 1 week, followed by 25ppm 8hrs/day for 5 weeks Gas is delivered to a patch over the wound |
|
| BG002 | C - Modified Treatment, 5 Wks Lower Dose | 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 |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| C - Modified Treatment, 5 Wks Lower Dose |
200 ppm NO gas 8 hrs / day 1 wk, 20ppm 8 hrs / day 5 weeks. Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound |
|
|
| Primary | Adverse Events (AEs) and Serious Adverse Events (SAEs) | All reported adverse events, related or unrelated to the study drug. | All enrolled subjects, 4 in total | Posted | Number | number of events | up to 24 weeks |
|
|
|
| 0 |
| 2 |
| 2 |
| 2 |
| EG001 | B Same Treatment for 6 Weeks | 200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound | 0 | 1 | 1 | 1 |
| EG002 | C - Modified Treatment, 5 Wks Lower Dose | 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 | 0 | 1 | 1 | 1 |
| Paronychia | Skin and subcutaneous tissue disorders | Non-systematic Assessment | paronychia was considered severe |
|
| epistaxis | General disorders | Non-systematic Assessment |
|
| blister formation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| deterioration of the wound | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| viral illness | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| wound infection | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
The PI is only allowed to publish the results of the trial with the permission of the Sponsor
| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Title | Measurements |
|---|---|
|