Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT01208220
Status:
TERMINATED
Last Update Posted:
2014-07-17
First Post:
2010-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effectiveness Study of Santyl Ointment to Treat Pressure Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003668', 'term': 'Pressure Ulcer'}], 'ancestors': [{'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054843', 'term': 'Negative-Pressure Wound Therapy'}, {'id': 'D017364', 'term': 'Collagenases'}], 'ancestors': [{'id': 'D004322', 'term': 'Drainage'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D058106', 'term': 'Wound Closure Techniques'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'smccal@lsushc.edu', 'phone': '318-813-2996', 'title': 'Dr. Stanley McCallon', 'organization': 'LSUShreveport'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'No adverse events noted or reported'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Negative Pressure Wound Therapy', 'description': 'NPWT alone for treatment of pressure ulcer\n\nNPWT - VAC : Vacuum Assisted Closure at 125 mm of negative pressure continuous, dressing changed three times weekly', 'otherNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Santyl Ointment and NPWT', 'description': 'Enzymatic debriding ointment used in conjunction with negative pressure wound therapy\n\nCollagenase Santyl : Topical enzyme applied to wound tissue', 'otherNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Removal of Harmful Fluids in the Wound Tissue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Negative Pressure Wound Therapy', 'description': 'NPWT alone for treatment of pressure ulcer\n\nNPWT - VAC : Vacuum Assisted Closure at 125 mm of negative pressure continuous, dressing changed three times weekly'}, {'id': 'OG001', 'title': 'Santyl Ointment and NPWT', 'description': 'Enzymatic debriding ointment used in conjunction with negative pressure wound therapy\n\nCollagenase Santyl : Topical enzyme applied to wound tissue'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 weeks into study', 'unitOfMeasure': 'percentage of cytotoxins removed', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Quicker Filling of the Wound With Good Tissue (vs. Treatment With NPWT Alone)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Negative Pressure Wound Therapy', 'description': 'NPWT alone for treatment of pressure ulcer\n\nNPWT - VAC : Vacuum Assisted Closure at 125 mm of negative pressure continuous, dressing changed three times weekly'}, {'id': 'OG001', 'title': 'Santyl Ointment and NPWT', 'description': 'Enzymatic debriding ointment used in conjunction with negative pressure wound therapy\n\nCollagenase Santyl : Topical enzyme applied to wound tissue'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 weeks into study', 'unitOfMeasure': 'Percentage of red granulation tissue', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Negative Pressure Wound Therapy', 'description': 'NPWT alone for treatment of pressure ulcer\n\nNPWT - VAC : Vacuum Assisted Closure at 125 mm of negative pressure continuous, dressing changed three times weekly'}, {'id': 'FG001', 'title': 'Santyl Ointment and NPWT', 'description': 'Enzymatic debriding ointment used in conjunction with negative pressure wound therapy\n\nCollagenase Santyl : Topical enzyme applied to wound tissue'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Large acute care hospital'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Negative Pressure Wound Therapy', 'description': 'NPWT alone for treatment of pressure ulcer\n\nNPWT - VAC : Vacuum Assisted Closure at 125 mm of negative pressure continuous, dressing changed three times weekly'}, {'id': 'BG001', 'title': 'Santyl Ointment and NPWT', 'description': 'Enzymatic debriding ointment used in conjunction with negative pressure wound therapy\n\nCollagenase Santyl : Topical enzyme applied to wound tissue'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52', 'spread': '0', 'groupId': 'BG000'}, {'value': '57', 'spread': '0', 'groupId': 'BG001'}, {'value': '54', 'spread': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Low enrollment of qualified subjects', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-16', 'studyFirstSubmitDate': '2010-04-16', 'resultsFirstSubmitDate': '2013-09-24', 'studyFirstSubmitQcDate': '2010-09-22', 'lastUpdatePostDateStruct': {'date': '2014-07-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-16', 'studyFirstPostDateStruct': {'date': '2010-09-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quicker Filling of the Wound With Good Tissue (vs. Treatment With NPWT Alone)', 'timeFrame': '2 weeks into study'}], 'secondaryOutcomes': [{'measure': 'Removal of Harmful Fluids in the Wound Tissue', 'timeFrame': '2 weeks into study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Collagenase Santyl', 'Enzymatic debridement', 'maintenance debridement', 'VAC', 'NPWT'], 'conditions': ['Pressure Ulcer', 'Soft Tissue Necrosis Lower Limb']}, 'descriptionModule': {'briefSummary': 'Researchers at LSUHSC-S hope to learn the effects of the combination of a medication and a device which by themselves are effective for the treatment of wounds.\n\nYou are being asked to take part in this study because you have a wound on your body which has not responded to standard treatments.\n\nThe researchers will be studying whether the combination of two treatments will make wounds heal faster. For those in study, the investigators will treat them with a vacuum device on their wound. Also, some of the people in the study will receive a special ointment and researchers will use special tests to determine if the two treatments together are working better than just one treatment alone.', 'detailedDescription': 'Evaluate the effectiveness of Collagenase Santyl ointment when used in conjunction with NPWT for the treatment of chronic pressure ulcers and determine whether the addition of Collagenase Santyl ointment has a positive effect on wound healing. Through volumetric changes and histological evaluation, we wish to test the hypothesis that the application of Collagenase Santyl ointment in conjunction with NPWT facilitates improved wound healing and mitigates some potentially harmful effects of NPWT alone (e.g. pain with dressing removal and tissue ingrowth'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 85 year-old competent adults in inpatient setting (no prisoners, mentally ill, or children)\n* Pressure ulcers to pelvis/abdomen/trunk and or upper extremities which have been refractory to prior treatment interventions and contain less than or equal to 25% necrotic tissue in wound bed (as percentage of total surface area)\n\nExclusion Criteria:\n\n* Lower extremity/foot wounds related to arterial insufficiency, incarcerated individuals, patients with untreated osteomyelitis, uncorrected coagulopathy, malignancy, sensitivity to collagenase, wounds with evidence of clinical infection (via swab culture or punch biopsy)'}, 'identificationModule': {'nctId': 'NCT01208220', 'briefTitle': 'Effectiveness Study of Santyl Ointment to Treat Pressure Ulcers', 'organization': {'class': 'OTHER', 'fullName': 'Louisiana State University Health Sciences Center Shreveport'}, 'officialTitle': 'The Effects of Collagenase Santyl Ointment and Negative Pressure Wound Therapy(Npwt) for the Treatment of Chronic Pressure Ulcers.', 'orgStudyIdInfo': {'id': 'Healthpoint-123-Collagenase'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Negative pressure wound therapy', 'description': 'NPWT changed TIW', 'interventionNames': ['Device: Negative Pressure Wound Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'NPWT plus Collagenase Ointment', 'description': 'Collagenase applied TIW with NPWT', 'interventionNames': ['Biological: Collagenase Ointment']}], 'interventions': [{'name': 'Negative Pressure Wound Therapy', 'type': 'DEVICE', 'otherNames': ['NPWT'], 'description': 'NPWT changed 3 times weekly', 'armGroupLabels': ['Negative pressure wound therapy']}, {'name': 'Collagenase Ointment', 'type': 'BIOLOGICAL', 'description': 'Apply TIW', 'armGroupLabels': ['NPWT plus Collagenase Ointment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71103', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'LSU Health Sciences Center', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}], 'overallOfficials': [{'name': 'Stanley K McCallon, DPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LSUHSC professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Louisiana State University Health Sciences Center Shreveport', 'class': 'OTHER'}, 'collaborators': [{'name': 'Healthpoint', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor - School of Physical Therapy', 'investigatorFullName': 'Dr. Stanley McCallon', 'investigatorAffiliation': 'Louisiana State University Health Sciences Center Shreveport'}}}}