Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT04319120
Status:
RECRUITING
Last Update Posted:
2023-05-06
First Post:
2020-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Study of Description of Cicatrisation Rates of Digital Ulcers in Systemic Scleroderma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 78}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-04', 'studyFirstSubmitDate': '2020-03-20', 'studyFirstSubmitQcDate': '2020-03-20', 'lastUpdatePostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of digital ulcers', 'timeFrame': '1 year', 'description': 'Number of digital ulcers healed at the end of the study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Scleroderma - Digital Ulcers'], 'conditions': ['Scleroderma, Systemic']}, 'descriptionModule': {'briefSummary': 'To make an updated inventory of digital ulcer care protocols in scleroderma patients and to specify the French data on monthly healing rates and local care with patients in care centers experience, and thus to know the impact of ulcers in different dimensions To evaluate the rate of healed digital ulcers at the end of the study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with systemic scleroderma', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with systemic scleroderma according to the ACR / EULAR 2012 criteria\n* Patient with one or more active digital ulcers\n* Patient with internet access and camera or smartphone\n\nExclusion Criteria:\n\n* Minor patients\n* Patient deprived of liberty or subject to a court order\n* Patient subject to a legal protection measure\n* Pregnant or lactating woman\n* Patient unable to complete the questionnaires'}, 'identificationModule': {'nctId': 'NCT04319120', 'acronym': 'POPSUD', 'briefTitle': 'Pilot Study of Description of Cicatrisation Rates of Digital Ulcers in Systemic Scleroderma', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Limoges'}, 'officialTitle': 'Pilot Study of descriPtion of cicatriSation Rates of Digital Ulcers in Systemic scleroDerma', 'orgStudyIdInfo': {'id': '87RI18_0017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'questionnaires online', 'description': 'Each month, the nurse will contact the patients included, by mail or telephone, to fill out their questionnaires online or by mail, and to make a photo of the ulcer if it is healed.', 'interventionNames': ['Other: questionnaires online']}], 'interventions': [{'name': 'questionnaires online', 'type': 'OTHER', 'description': 'Each month, the nurse will contact the patients included, by mail or telephone, to fill out their questionnaires online or by mail, and to make a photo of the ulcer if it is healed. A dedicated telephone line and e-mail address will be used as a support if necessary (for questionnaires, emails or sending photos). The referring nurse and the clinical research assistant of the service will be in charge of centralizing the data collected.', 'armGroupLabels': ['questionnaires online']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33000', 'city': 'Bordeaux', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stéphanie COMOZ', 'role': 'CONTACT'}, {'name': 'Stéphanie COMOZ', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Bordeaux Hospital', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '87042', 'city': 'Limoges', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nolga BOUSSELY', 'role': 'CONTACT'}, {'name': 'Nolga BOUSSELY', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Limoges Hospital', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '31000', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'François-Xavier LAPEBIE', 'role': 'CONTACT'}, {'name': 'François-Xavier LAPEBIE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Toulouse Hospital', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Nolga BOUSSELY', 'role': 'CONTACT', 'email': 'Nolga.boussely@chu-limoges.fr', 'phone': '0555056959'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Limoges', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}