Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2026-03-09 @ 2:43 PM
Study NCT ID:
NCT02070835
Status:
COMPLETED
Last Update Posted:
2024-02-08
First Post:
2014-02-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Autologous Skin Cell Treating for Diabetic Foot Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}], 'ancestors': [{'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016523', 'term': 'Foot Ulcer'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016038', 'term': 'Skin Transplantation'}], 'ancestors': [{'id': 'D016378', 'term': 'Tissue Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D062109', 'term': 'Dermatologic Surgical Procedures'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D014180', 'term': 'Transplantation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-06', 'studyFirstSubmitDate': '2014-02-22', 'studyFirstSubmitQcDate': '2014-02-22', 'lastUpdatePostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'complication rate', 'timeFrame': 'postsurgery week 4', 'description': 'the percentage of subjects that who could not achieved complete wound closure by week 4'}], 'primaryOutcomes': [{'measure': 'healing rate', 'timeFrame': 'postsurgery week 4', 'description': 'the percentage of subjects that achieved complete wound closure by week 4, herein complete wound closure is defined as skin re-epithelialization without drainage or dressing requirements'}], 'secondaryOutcomes': [{'measure': 'recurrent rate', 'timeFrame': 'postsurgery months 6', 'description': 'the incidence of ulcer recurrence at months 6. Recurrence will be defined as an ulcer occurring at the same location as the healed study ulcer'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetic Foot Ulcer', 'Autologous skin cell'], 'conditions': ['Diabetic Foot Ulcer']}, 'descriptionModule': {'briefSummary': 'Diabetic foot ulcer is one of the refractory wounds and always poses many challenges in clinical practice. This study was conducted to have a prospective, randomised, controlled study compare the safety and efficacy of the autologous skin cell with skin graft (experiment group) with split-thickness skin graft (STSG, control group) alone on treating diabetic foot ulcers.', 'detailedDescription': 'The primary objective of this study is to assess the effectiveness and safety of autologous skin cell with skin graft (experiment group) vs. skin graft (control group) for the treatment of non-healing diabetic foot ulcers. Our hypothesis is that the methods of experiment group is better than the control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients aged over 18 years old\n* with a diagnosis of type 1 or type 2 diabetes\n* who had a diabetic low extremity ulcer last for over 4 weeks\n* with a stage 2 by Wagner's scale\n* size more than 3 cm2\n* absence of vascular reconstruction (ankle brachial indices between 0.7 and 1.2)\n* had indications of skin grafting were eligible for inclusion\n\nExclusion Criteria:\n\n* patients with medical conditions that would impair wound healing (e.g. malignancy, autoimmune disease),\n* using corticosteroids or immunosuppressor\n* a high anesthesiology or surgical risk\n* uncontrolled hyperglycemia (preoperative HbA1c greater than 12.0%)"}, 'identificationModule': {'nctId': 'NCT02070835', 'briefTitle': 'Study of Autologous Skin Cell Treating for Diabetic Foot Ulcers', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital, Sun Yat-Sen University'}, 'officialTitle': 'Autologous Skin Cell Versus Classic Skin Grafts in Treatment of Diabetic Foot Ulcers: a Comparative Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SYSU-2013-048'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'autologous skin cell', 'description': 'autologous skin cell with skin graft', 'interventionNames': ['Device: autologous skin cell']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'skin graft', 'description': 'split-thickness skin graft as control group', 'interventionNames': ['Procedure: skin graft']}], 'interventions': [{'name': 'autologous skin cell', 'type': 'DEVICE', 'description': 'autologous skin cell and skin graft', 'armGroupLabels': ['autologous skin cell']}, {'name': 'skin graft', 'type': 'PROCEDURE', 'description': 'split-thickness skin graft', 'armGroupLabels': ['skin graft']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Department of Burn Surgery, The First Affiliated Hospital of Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Jiayuan Zhu, PI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Burns, The First Affiliated Hospital, Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hu Zhicheng', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'FirstSunYetSen', 'investigatorFullName': 'Hu Zhicheng', 'investigatorAffiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}}}}