Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2025-12-28 @ 9:40 PM
Study NCT ID:
NCT01567150
Status:
COMPLETED
Last Update Posted:
2016-11-25
First Post:
2012-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Wound Fluid Protease Levels During Use of Novel Wound Dressing
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014647', 'term': 'Varicose Ulcer'}], 'ancestors': [{'id': 'D014648', 'term': 'Varicose Veins'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ginger.salvadalena@hollister.com', 'phone': '8479183996', 'title': 'Director, Global Clinical Affairs', 'organization': 'Hollister Incorporated'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Novel Dressing', 'description': 'Treatment with novel dressing\n\nNovel Dressing: Topical wound dressing', 'otherNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Control is treatment without novel dressing', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Matrix Metalloproteinase Level in Wound Fluid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Novel Dressing', 'description': 'Treatment with novel dressing\n\nNovel Dressing: Topical wound dressing'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control is treatment without novel dressing'}], 'classes': [{'categories': [{'measurements': [{'value': '0.71', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '0.88', 'spread': '0.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Wound fluid will be collected and analyzed at baseline and approximately every 7 days.\n\nMean was calculated for each subject. Means and standard deviation were calculated for the treatment and control groups.', 'unitOfMeasure': 'mcg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall mean across 8 week timeframe'}, {'type': 'SECONDARY', 'title': 'Wound Healing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Novel Dressing', 'description': 'Treatment with novel dressing\n\nNovel Dressing: Topical wound dressing'}, {'id': 'OG001', 'title': 'Control', 'description': 'Control is treatment without novel dressing'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.99', 'spread': '8.22', 'groupId': 'OG000'}, {'value': '-2.49', 'spread': '6.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'change in wound area mean was calculated for each subject Mean and sd were calculated for each group', 'unitOfMeasure': 'square cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'average across 12 week time frame'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Novel Dressing', 'description': 'Treatment with novel dressing\n\nNovel Dressing: Topical wound dressing'}, {'id': 'FG001', 'title': 'Control', 'description': 'Control is treatment without novel dressing'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': '4 subjects attended only one study visit thus did not have evaluable data'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Novel Dressing', 'description': 'Treatment with novel dressing\n\nNovel Dressing: Topical wound dressing'}, {'id': 'BG001', 'title': 'Control', 'description': 'Control is treatment without novel dressing'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.1', 'spread': '14.9', 'groupId': 'BG000'}, {'value': '60.6', 'spread': '12.9', 'groupId': 'BG001'}, {'value': '58.1', 'spread': '14.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-04', 'studyFirstSubmitDate': '2012-03-23', 'resultsFirstSubmitDate': '2015-09-22', 'studyFirstSubmitQcDate': '2012-03-28', 'lastUpdatePostDateStruct': {'date': '2016-11-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-10-04', 'studyFirstPostDateStruct': {'date': '2012-03-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Matrix Metalloproteinase Level in Wound Fluid', 'timeFrame': '8 weeks', 'description': 'Wound fluid will be collected and analyzed at baseline and approximately every 7 days.\n\nMean was calculated for each subject. Means and standard deviation were calculated for the treatment and control groups.'}], 'secondaryOutcomes': [{'measure': 'Wound Healing', 'timeFrame': '12 weeks', 'description': 'change in wound area mean was calculated for each subject Mean and sd were calculated for each group'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Venous Stasis Ulcers']}, 'descriptionModule': {'briefSummary': 'This study is being conducted to characterize the way leg wounds respond to a new type of wound dressing, compared to wounds in patients who are not using the new dressing. The investigators will collect wound fluid for biochemical analysis, and they will measure the wound healing that occurs with and without the new dressing.', 'detailedDescription': 'Abnormal wound healing is characterized by prolonged inflammation and excess degradation of the extracellular matrix through the activity of proteinases and other enzymes. Wound fluids can provide biochemical information about the healing status of chronic wounds and the effects of wound treatments. In this study the investigators will obtain samples of wound fluid and measure healing in wounds randomized to receive the novel dressing or a control. The findings will be compared between the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of venous insufficiency\n* One or more partial or full-thickness venous leg ulcers 5-24 sq. cm in size without evidence of clinical infection\n* Ankle/brachial index 0.8 and above\n* Duration of wound up to one year\n* Able to return to wound clinic for weekly evaluations\n* Has signed Institutional Review Board approved informed consent\n\nExclusion Criteria:\n\n* Exposed bone or tendon or necrotic wound base\n* Signs or symptoms of cellulitis or osteomyelitis at the target ulcer\n* Allergy to a component of the novel dressing or compression wrap\n* Third degree burn\n* Vasculitis, severe rheumatoid arthritis or other collagen vascular disease\n* Receiving antibiotics\n* Pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT01567150', 'briefTitle': 'Wound Fluid Protease Levels During Use of Novel Wound Dressing', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hollister Incorporated'}, 'officialTitle': 'Wound Fluid Protease Levels During Use of Novel Wound Dressing', 'orgStudyIdInfo': {'id': '5064-W'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'novel dressing', 'description': 'Treatment with novel dressing', 'interventionNames': ['Device: Novel Dressing']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control is treatment without novel dressing'}], 'interventions': [{'name': 'Novel Dressing', 'type': 'DEVICE', 'description': 'Topical wound dressing', 'armGroupLabels': ['novel dressing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Heart Hospital', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85015', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix Baptist Hospital', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami, Department of Surgery, Div. of Vascular Surgery', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60007', 'city': 'Elk Grove Village', 'state': 'Illinois', 'country': 'United States', 'facility': 'Alexian Brothers Medical Center Wound Healing Center', 'geoPoint': {'lat': 42.00392, 'lon': -87.97035}}, {'zip': '48439', 'city': 'Grand Blanc', 'state': 'Michigan', 'country': 'United States', 'facility': 'Genesys Regional Medical Center', 'geoPoint': {'lat': 42.92753, 'lon': -83.62995}}, {'zip': '10010', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43113', 'city': 'Circleville', 'state': 'Ohio', 'country': 'United States', 'facility': 'Circleville Foot & Ankle', 'geoPoint': {'lat': 39.60062, 'lon': -82.94601}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor University Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Ginger Salvadalena, PhD, RN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hollister Incorporated'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hollister Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}