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:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009569', 'term': 'Nitric Oxide'}], 'ancestors': [{'id': 'D026361', 'term': 'Reactive Nitrogen Species'}, {'id': 'D005609', 'term': 'Free Radicals'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D009589', 'term': 'Nitrogen Oxides'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ddodge@llu.edu', 'phone': '(909) 558-4000', 'title': 'Deborah Dodge', 'phoneExt': '48500', 'organization': 'Loma Linda University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'No data available for this study due to dissolution of company contracted to perform study analysis.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Group 1', 'description': 'Treatment', 'otherNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Primary Endpoint is the Eradication of the Bio-burden as Measured by a Reduction in Culture Growth to ≤ +2.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Treatment'}], 'timeFrame': 'at 28 days post enrollment', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not available for this study due to dissolution of company contracted to perform study analysis'}, {'type': 'SECONDARY', 'title': 'The Secondary Endpoint Measure is a Reduction on Wound Size.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': "reduction in bioburden as assessed by number of cfu's per cm2 on culture"}], 'timeFrame': '28 days post enrollment', 'description': "reduction in bioburden as assessed by number of cfu's per cm2 on culture", 'reportingStatus': 'POSTED', 'populationDescription': 'Data not available for this study due to dissolution of company contracted to perform analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Topically Applied Nitric Oxide', 'description': 'Topically applied gaseous nitric oxide at 8 to 10 parts per million, for 8 hours each night for 14 nights.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1', 'description': 'Treatment'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Evidence of a colonized wound on the lower extremity.', 'classes': [{'title': '>=65 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': '18 to 65 years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': "Subject recuitment halted and won't resume; subjects are no longer being treated.", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-28', 'studyFirstSubmitDate': '2009-01-13', 'resultsFirstSubmitDate': '2013-08-02', 'studyFirstSubmitQcDate': '2009-01-14', 'lastUpdatePostDateStruct': {'date': '2016-02-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-02', 'studyFirstPostDateStruct': {'date': '2009-01-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Primary Endpoint is the Eradication of the Bio-burden as Measured by a Reduction in Culture Growth to ≤ +2.', 'timeFrame': 'at 28 days post enrollment'}], 'secondaryOutcomes': [{'measure': 'The Secondary Endpoint Measure is a Reduction on Wound Size.', 'timeFrame': '28 days post enrollment', 'description': "reduction in bioburden as assessed by number of cfu's per cm2 on culture"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['chronic cutaneous ulcers', 'Nitric Oxide', 'topically applied', 'Biofilm', 'Colonized chronic non-healing ulcers'], 'conditions': ['Chronic Ulcer of Lower Extremity']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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:\n\n* Comparisons of the demographics and diagnoses of those patients treated with ViaNOx-H.\n* Tabulation as to the organisms found and the bio-burden as measured by counts (0 to +4).\n* Tabulation of the number and types of adverse events during ViaNOx-H treatment.\n* Comparisons of the response of different organisms to ViaNOx-H treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Are 18 years of age or older.\n\nExclusion Criteria:\n\n* Have had a change in their topical treatment during the last 4 weeks\n* Have evidence of Clinical Infection\n* Have a transcutaneous oxygen tension \\<30mmHg\n* Have evidence of the ulcer or infection extending to the underlying muscle or bone.\n* Are pregnant.\n* Are less than 18 years of age.'}, 'identificationModule': {'nctId': 'NCT00823095', 'briefTitle': 'Topical Nitric Oxide Trial in Chronic Non-Healing Wounds', 'organization': {'class': 'OTHER', 'fullName': 'Loma Linda University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'TNO-1B'}, 'secondaryIdInfos': [{'id': 'DMF 15551'}, {'id': 'IND 68617'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Topically applied Nitric Oxide', 'description': 'Topically applied Nitric Oxide for 8 hours daily for 2 weeks.', 'interventionNames': ['Drug: Nitric Oxide']}], 'interventions': [{'name': 'Nitric Oxide', 'type': 'DRUG', 'otherNames': ['ViaNOx-H', 'gaseous nitric oxide', 'gNO'], 'description': 'Topically applied gaseous nitric oxide at 8 to 10 parts per million, for 8 hours each night for 14 nights.', 'armGroupLabels': ['Topically applied Nitric Oxide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Medical Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}], 'overallOfficials': [{'name': 'Takkin Lo, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loma Linda University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loma Linda University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nitric BioTherapeutics, Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}