Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2026-02-24 @ 3:15 PM
Study NCT ID:
NCT01716169
Status:
COMPLETED
Last Update Posted:
2016-05-05
First Post:
2012-10-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment of Chronic and Non-Chronic Wounds in Patients With Recessive Dystrophic Epidermolysis Bullosa Using Helicoll Collagen Dressings Versus Standard of Care
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016108', 'term': 'Epidermolysis Bullosa Dystrophica'}, {'id': 'D004820', 'term': 'Epidermolysis Bullosa'}], 'ancestors': [{'id': 'D012868', 'term': 'Skin Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D003095', 'term': 'Collagen Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D012872', 'term': 'Skin Diseases, Vesiculobullous'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'atlane@stanford.edu', 'phone': '650 721 7166', 'title': 'Dr. Alfred Lane', 'organization': 'Stanford School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Helicoll - Chronic Wound', 'description': 'Helicoll will be applied to one chronic wound (approximately 6 months or more duration)\n\nHelicoll: Helicoll Collagen I Wound Dressing', 'otherNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard of Care - Chronic Wound', 'description': 'Standard of Care wound dressings (e.g. Vaseline gauze) will be applied to one chronic wound (of approximately 6 months duration) if the subject has more than one chronic wound of approximately the same size and duration as Helicoll chronic wound.', 'otherNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Wound Surface Area Change From Baseline to Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Helicoll - Chronic Wound', 'description': 'Helicoll will be applied to one chronic wound (approximately 6 months or more duration)\n\nHelicoll: Helicoll Collagen I Wound Dressing'}, {'id': 'OG001', 'title': 'Standard of Care Dressing - Chronic Wound', 'description': 'Standard of Care dressings will be applied to one chronic wound'}], 'classes': [{'categories': [{'measurements': [{'value': '-63', 'groupId': 'OG000', 'lowerLimit': '-99.1', 'upperLimit': '-26.9'}, {'value': '-8.1', 'groupId': 'OG001', 'lowerLimit': '-34.4', 'upperLimit': '18.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 8', 'description': 'Change was assessed in terms of wound surface area, as measured using the ARANZ camera. Week 8 surface area measurement was compared to baseline surface area measurement and percentage in size change was calculated.', 'unitOfMeasure': 'percentage of wound surface area', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Helicoll - Chronic Wound', 'description': 'Helicoll will be applied to one chronic wound (approximately 6 months or more duration)\n\nHelicoll: Helicoll Collagen I Wound Dressing'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Standard of Care Dressings Used', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'inconsistent dressing application', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment from EB Clinic patients, organization website'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Helicoll - Chronic Wound', 'description': 'Helicoll will be applied to one chronic wound (approximately 6 months or more duration)\n\nHelicoll: Helicoll Collagen I Wound Dressing'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '15.6', 'spread': '5.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-01', 'studyFirstSubmitDate': '2012-10-25', 'resultsFirstSubmitDate': '2015-05-22', 'studyFirstSubmitQcDate': '2012-10-26', 'lastUpdatePostDateStruct': {'date': '2016-05-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-04-01', 'studyFirstPostDateStruct': {'date': '2012-10-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Wound Surface Area Change From Baseline to Week 8', 'timeFrame': 'Baseline and Week 8', 'description': 'Change was assessed in terms of wound surface area, as measured using the ARANZ camera. Week 8 surface area measurement was compared to baseline surface area measurement and percentage in size change was calculated.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Epidermolysis Bullosa Dystrophica', 'Epidermolysis Bullosa']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the effectiveness of Helicoll (a collagen wound dressing) in treating chronic and non-chronic wounds of recessive dystrophic epidermolysis bullosa (RDEB) patients. Helicoll will be compared to standard wound dressings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Written consent must be obtained from subjects over age 18, or from a parent or legally authorized representative if subject is under 18. Assent will be obtained from subjects age 7 - 17.\n2. Subjects with a clinical diagnosis of RDEB by a dermatologist.\n3. Have at least three target wounds that meet the following criteria:\n\n * One chronic wound, of approximately 6 months or more duration. If the subject has an additional chronic wound of similar size and duration, this additional wound will be treated with standard dressings and followed in the study. A wound in an area that consistently heals and then breaks down again will be considered a chronic wound.\n * Two non-chronic wounds, of approximately 3 months or less duration, of similar size, and able to be dressed separately. Both wounds should have approximately the same duration.\n\n All wounds must be:\n * Open, and not scabbed or crusted over\n * Not actively infected\n * Not requiring surgical intervention\n4. A parent or legally authorized representative must be willing and able to ensure subject is present for all required study visits (for minor subjects).\n5. The subject or caregiver (or a parent or legally authorized representative for subjects under 18) must be able to follow instructions.\n6. Subject must be age 7 or older.\n\nExclusion criteria:\n\n1. Inability to travel to Stanford for study visits.\n2. Complicating illness as determined by study investigators to be exclusionary including any infection requiring systemic antibiotics.\n3. Presence or history of squamous cell carcinoma at target wound site.\n4. Known bovine (cow) or ovine (sheep) sensitivity.\n5. Therapy with an investigational agent during the study.'}, 'identificationModule': {'nctId': 'NCT01716169', 'briefTitle': 'Treatment of Chronic and Non-Chronic Wounds in Patients With Recessive Dystrophic Epidermolysis Bullosa Using Helicoll Collagen Dressings Versus Standard of Care', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Treatment of Chronic and Non-Chronic Wounds in Patients With Recessive Dystrophic Epidermolysis Bullosa Using Helicoll Collagen Dressings Versus Standard of Care', 'orgStudyIdInfo': {'id': '24915'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Helicoll', 'description': 'Helicoll will be applied to one chronic wound (approximately 6 months or more duration).\n\nWound designations of "control" or "Helicoll" were placed in a sealed envelope prior to study start. When a subject was enrolled, wounds were identified as "A" or "B". Then the envelope was opened which designated whether A or B would receive control or Helicoll.', 'interventionNames': ['Device: Helicoll', 'Device: Standard of Care Dressings']}], 'interventions': [{'name': 'Helicoll', 'type': 'DEVICE', 'description': 'Helicoll Collagen I Wound Dressing', 'armGroupLabels': ['Helicoll']}, {'name': 'Standard of Care Dressings', 'type': 'DEVICE', 'description': 'Standard of Care wound dressings (e.g. Vaseline gauze)', 'armGroupLabels': ['Helicoll']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Alfred Lane, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Dermatology and Pediatrics', 'investigatorFullName': 'Alfred Lane', 'investigatorAffiliation': 'Stanford University'}}}}