Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-01-08 @ 6:48 AM
Study NCT ID:
NCT02742233
Status:
UNKNOWN
Last Update Posted:
2017-08-08
First Post:
2016-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dipeptidyl Peptidase 4 Inhibition Facilitate Healing of Diabetic Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2018-09-20', 'releaseDate': '2017-12-25'}, {'resetDate': '2019-03-15', 'releaseDate': '2018-12-03'}, {'resetDate': '2023-09-15', 'releaseDate': '2022-11-26'}, {'resetDate': '2024-03-22', 'releaseDate': '2023-09-18'}], 'estimatedResultsFirstSubmitDate': '2017-12-25'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C502994', 'term': 'saxagliptin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-06', 'studyFirstSubmitDate': '2016-03-24', 'studyFirstSubmitQcDate': '2016-04-13', 'lastUpdatePostDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Net change from baseline in laboratory test results', 'timeFrame': 'Baseline, weeks 1, 2,4,'}, {'measure': 'New ulcers', 'timeFrame': '16 weeks', 'description': 'new ulcers among the participants during treatment period'}], 'primaryOutcomes': [{'measure': "Completely healing time of the participants'target ulcer during the treatment period.", 'timeFrame': '16 weeks', 'description': 'Complete ulcer closure is defined as 100% skin re-epithelialization'}], 'secondaryOutcomes': [{'measure': 'Proportion of participants with complete healing during the treatment period.', 'timeFrame': '16 weeks', 'description': 'Complete ulcer closure is defined as 100% skin re-epithelialization'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetes', 'Wound Healing', 'Dipeptidyl Peptidase 4 Inhibition'], 'conditions': ['Diabetic Foot Ulcer']}, 'descriptionModule': {'briefSummary': 'To investigate the effect of Dipeptidyl Peptidase 4 Inhibition on wound healing in patients with diabetic foot ulcers, the investigators randomly divided the participants into two groups: saxagliptin with regular treatment group，placebo with regular treatment group. The clinical data are collected at the given time point. This study aimed to observe the potential protective effect of DPP4i on diabetic ulcers.', 'detailedDescription': 'Groups:\n\nDiabetic ulcers, saxagliptin + Regular treatment.\n\nDiabetic ulcers, placebo + Regular treatment.\n\nTime Point:\n\nInitial treatment;\n\nPost-treatment ( 1w );\n\nPost-treatment ( 2w );\n\nPost-treatment ( 4w );\n\nCompletely healed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of diabetes mellitus according to World Health Organization criteria ( treatment with insulin or an oral hypoglycemic agent, twice random glucose measurements major than 200 mg/dl, or a fasting glucose major than 140 mg/dl)\n* Ulcer located on the legs or feet, stage III or IV (Wagner Classification System)\n* The subject agrees to comply with study protocol requirements and all follow up visit requirements.\n\nExclusion Criteria:\n\n* Uncontrolled diabetes\n* Ulcer infection\n* Non-diabetic ulcers Orthopedic or neuromuscular pathologic conditions'}, 'identificationModule': {'nctId': 'NCT02742233', 'acronym': 'DPP4i', 'briefTitle': 'Dipeptidyl Peptidase 4 Inhibition Facilitate Healing of Diabetic Ulcers', 'organization': {'class': 'OTHER', 'fullName': 'Xinqiao Hospital of Chongqing'}, 'officialTitle': 'A Controlled Clinical Trial of Dipeptidyl Peptidase 4 Inhibition Facilitate Healing of Diabetic Ulcers', 'orgStudyIdInfo': {'id': 'XinqiaoH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'saxagliptin', 'description': 'saxagliptin \\& Regular treatment:\n\nsaxagliptin, brand name，Bristol-Myers, Squibb, dose: 5mg, po, qd', 'interventionNames': ['Drug: saxagliptin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo \\& Regular treatment:\n\nplacebo, dose: 5mg, po, qd', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'saxagliptin', 'type': 'DRUG', 'otherNames': ['ONGLYZA'], 'description': 'Qualifying Period: Participants will receive regular treatment for diabetic ulcer without DPP4i.\n\nTreatment Period: Participants will receive saxagliptin with regular treatment', 'armGroupLabels': ['saxagliptin']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['dummy pills'], 'description': 'Qualifying Period: Participants will receive regular treatment for diabetic ulcer without DPP4i.\n\nTreatment Period: Participants will receive placebo with regular treatment', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400037', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongting Zheng, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Second Affiliated Hospital, Third Military Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Min Long, MD', 'role': 'CONTACT', 'email': 'longmin_casper@163.com', 'phone': '023-68763255'}, {'name': 'Leiqin Cai', 'role': 'CONTACT', 'email': 'caileiqin@outlook.com', 'phone': '18580027792'}], 'overallOfficials': [{'name': 'Hongting Zheng, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Department of Endocrinology,The Second Affiliated Hospital, Third Military Medical University, Chongqing, People's Republic of China."}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'age，the grade of the diabetic ulcers, sex, diabetes duration, healing time, treatment. ect'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Long Min,MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Long Min,MD', 'investigatorAffiliation': 'Xinqiao Hospital of Chongqing'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-12-25', 'type': 'RELEASE'}, {'date': '2018-09-20', 'type': 'RESET'}, {'date': '2018-12-03', 'type': 'RELEASE'}, {'date': '2019-03-15', 'type': 'RESET'}, {'date': '2022-11-26', 'type': 'RELEASE'}, {'date': '2023-09-15', 'type': 'RESET'}, {'date': '2023-09-18', 'type': 'RELEASE'}, {'date': '2024-03-22', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Long Min,MD, Principal Investigator, Xinqiao Hospital of Chongqing'}}}}