Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2026-06-18 @ 7:50 PM
Study NCT ID:
NCT03248466
Status:
UNKNOWN
Last Update Posted:
2017-08-14
First Post:
2017-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PRG Combined With Autologous BMMSCs for Treatment of Diabetic Foot Ulcer
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'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'diabetic foot ulcer which Wagner classification at 2-3 grade.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-08-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-11', 'studyFirstSubmitDate': '2017-08-09', 'studyFirstSubmitQcDate': '2017-08-11', 'lastUpdatePostDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amputation rate', 'timeFrame': 'up to 6 months', 'description': 'Amputation rate up to 6 months'}, {'measure': 'hospital stay', 'timeFrame': 'up to 6 months', 'description': 'hospital stay'}], 'secondaryOutcomes': [{'measure': 'Wound healing time', 'timeFrame': 'up to 6 months', 'description': 'Wound healing time'}, {'measure': 'Transcutaneous oxygen partial pressure', 'timeFrame': 'Transcutaneous oxygen partial pressure up to 6 months', 'description': 'Transcutaneous oxygen partial pressure'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['platelet rich gel', 'BMMSCs', 'diabetic foot ulcer'], 'conditions': ['Diabetic Foot Ulcer']}, 'descriptionModule': {'briefSummary': 'To investigate the treatment effect between Traditional treatment and transplantation of autologous PRG combined with autologous BMMSCs for treatment of diabetic foot ulcer.', 'detailedDescription': "60 diabetic foot ulcer in our hospital will divide into 3 groups: group A (20 diabetic foot ulcer who give Traditional treatment), group B (20 diabetic foot ulcer who give Traditional treatment and transplantation of autologous platelet rich gel)，group C (20 diabetic foot ulcer who give Traditional treatment and transplantation of autologous platelet rich gel combined with autologous bone marrow mesenchymal stem cells). The age, height, weight, blood glucose, glycosylated hemoglobin A1c（HbA1c）, lipid, blood pressure, course of disease, Wound healing rate,transcutaneous oxygen pressure,Amputation rate,Hospital stay will record respectively. And High-sensitive C-reactive protein (HsCRP) and Tumor necrosis factor-α（TNF-α） will detect as Baseline. After each group's treatment, Change from baseline of all indexes will record, one way Analysis of Variance will be analyzed the significantion among 3 groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetic foot according to The Wagner is 2-3 graded;\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus,presence of autoimmune diabetes;\n* Gestational diabetes;\n* Patients with heart, liver, or renal function impairment;presence of severe infections or cerebrovascular disease.'}, 'identificationModule': {'nctId': 'NCT03248466', 'briefTitle': 'PRG Combined With Autologous BMMSCs for Treatment of Diabetic Foot Ulcer', 'organization': {'class': 'OTHER', 'fullName': 'Third Military Medical University'}, 'officialTitle': 'Transplantation of Autologous Platelet Rich Gel Combined With Autologous Bone Marrow Mesenchymal Stem Cells for Treatment of Diabetic Foot Ulcer', 'orgStudyIdInfo': {'id': 'endocrine department of TMMU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Traditional treatment', 'description': 'Traditional treatment such as insulin,antidiabetes,dressing', 'interventionNames': ['Biological: PRG combined with BMMSCs transplantation']}, {'type': 'EXPERIMENTAL', 'label': 'PRG combined with BMMSCs transplantation', 'description': 'Traditional treatment such as insulin,antidiabetes,dressing and Autologous PRG combined with BMMSCs', 'interventionNames': ['Biological: PRG combined with BMMSCs transplantation']}, {'type': 'NO_INTERVENTION', 'label': 'PRG treatment', 'description': 'Traditional treatment such as insulin,antidiabetes,dressing and Autologous PRG'}], 'interventions': [{'name': 'PRG combined with BMMSCs transplantation', 'type': 'BIOLOGICAL', 'otherNames': ['PRG'], 'description': 'PRG combined with BMMSCs transplantation', 'armGroupLabels': ['PRG combined with BMMSCs transplantation', 'Traditional treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '+86', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'wu qinan, doctor', 'role': 'CONTACT', 'email': 'wqn11@126.com', 'phone': '13452867542'}], 'facility': 'Southwest Hospital of the Third Military Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '400038', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'qinan wu, master', 'role': 'CONTACT', 'email': 'wqn11@126.com', 'phone': '02368765217', 'phoneExt': '86'}, {'name': 'qinan wu, master', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Endocrine Department, the First Affiliated Hospital of the Third Military Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Third Military Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Wu Qinan', 'investigatorAffiliation': 'Third Military Medical University'}}}}