Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-02-26 @ 12:03 PM
Study NCT ID:
NCT01446432
Status:
UNKNOWN
Last Update Posted:
2015-04-03
First Post:
2011-10-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of Two New Questionnaires for Dupuytren's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004387', 'term': 'Dupuytren Contracture'}], 'ancestors': [{'id': 'D005350', 'term': 'Fibroma'}, {'id': 'D018218', 'term': 'Neoplasms, Fibrous Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003286', 'term': 'Contracture'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-04-01', 'studyFirstSubmitDate': '2011-10-03', 'studyFirstSubmitQcDate': '2011-10-04', 'lastUpdatePostDateStruct': {'date': '2015-04-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'QuickDASH (Disability of the Arm, Shoulder, and Hand)', 'timeFrame': '30 day follow up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Dupuytren's Contracture"], 'conditions': ["Dupuytren's Disease"]}, 'descriptionModule': {'briefSummary': "A study to validate two newly developed questionnaires for Dupuytren's Disease. The objective is to develop a patient specific outcomes tool for Dupuytren's Disease. While there are standard and validated questionnaire instruments used to measure health related quality of life and function, they do not address patient specific issues. The investigators will also pilot a treatment/disease specific satisfaction questionnaire for Xiaflex use for Dupuytren's Disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients receiving treatment with XIAFLEX for Dupuytren's Disease", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject has a diagnosis of Dupuytren's Disease in at least one finger\n* Patients will be 35 years of age or older\n* Patients will be able to read, speak, and understand English\n* Patients will be able to provide voluntary written consent to participate\n\nExclusion Criteria:\n\n* Female patients who are nursing or pregnant, or plan to become pregnant during the treatment phase.\n* Patient has a chronic muscular, neurological or neuromuscular disorder that affects the hands.\n* Patient has a known allergy to collagenase or any other excipient of XIAFLEX.\n* Patient has received any collagenase treatments before the first dose of XIAFLEX.\n* Any history of or current medical condition which in the investigator's opinion would make the subject unsuitable for enrollment in the study"}, 'identificationModule': {'nctId': 'NCT01446432', 'briefTitle': "Validation of Two New Questionnaires for Dupuytren's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Hospital for Special Surgery, New York'}, 'officialTitle': "A Prospective Study to Validate Two New Patient Reported Outcome Measures for Dupuytren's Disease in Patients Treated With XIAFLEX", 'orgStudyIdInfo': {'id': '11011'}}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital For Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Robert N Hotchkiss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hosptial for Special Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Robert Hotchkiss', 'class': 'OTHER'}, 'collaborators': [{'name': 'Auxilium Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Robert Hotchkiss', 'investigatorAffiliation': 'Hospital for Special Surgery, New York'}}}}