Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-02-26 @ 8:12 PM
Study NCT ID:
NCT01173094
Status:
UNKNOWN
Last Update Posted:
2012-12-24
First Post:
2010-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimized Strategy for Diabetic Patients With Critical Limb Ischemia(Part II) (DCLI-II)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D000089802', 'term': 'Chronic Limb-Threatening Ischemia'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007511', 'term': 'Ischemia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017130', 'term': 'Angioplasty'}], 'ancestors': [{'id': 'D002404', 'term': 'Catheterization'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-12-20', 'studyFirstSubmitDate': '2010-07-28', 'studyFirstSubmitQcDate': '2010-07-28', 'lastUpdatePostDateStruct': {'date': '2012-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occlusion of the below-knee artery or bypass', 'timeFrame': '36 months'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '30 days', 'description': 'The number of death during the first month after procedure, no matter whether the cause of death is related to the procedure.'}, {'measure': 'Rate of limb salvage', 'timeFrame': '36 months'}, {'measure': 'Procedural complications, defined as any adverse event', 'timeFrame': '36 months', 'description': 'including MI, DVT, hematoma, renal failure, wound infection, lymphatic fistula'}, {'measure': 'Quality of Life assessment', 'timeFrame': '36 months', 'description': 'assessment in 1 month,6 months,12 months,24 months and 36 months post procedure'}, {'measure': 'Restenosis measured by Duplex Ultrasound or CTA', 'timeFrame': '36 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Critical limb ischemia', 'Diabetes Mellitus', 'Diabetes foot'], 'conditions': ['Vascular Diseases', 'Diabetes']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.vascular.cn/', 'label': 'the website of the vascular surgery department of PUMCH'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to find out the appropriate way to treat DM patients with critical limb ischemia. This trial includes two parts. Part I focuses on the treatment of femoral arterial lesion and part II focuses on the treatment of below-knee arterial lesion.', 'detailedDescription': 'The trial includes two parts and here is part II. This part is a multi-center, prospective, registration study which focuses on the treatment of below-knee arterial lesion. Totally 130 patients will be entered into this part. They should suffer ischemic symptom with Rutherford 3-6 for the occlusion of the below-knee arteries(anterior tibial、posterior tibial or peroneal artery). According to the lesion length, the patients will accept transluminal angioplasty or below-knee arterial bypass. They will be followed up for 3 years. Study examinations will be done at screening, procedure time, 1, 6, 12, 24 and 36 months after procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients volunteer to join the trial and sign the formal consent.\n* The patients are ≥55 year-old and ≤75 year-old.\n* The patients suffer from symptomatic leg ischemia with rutherford classification3, 4 , 5 or 6.\n* Obvious stenosis or occlusion in below-knee popliteal artery\n* No obvious stenosis or occlusion in the aortoiliac artery; or the lesion could be treated simultaneously or has already been cured.\n* No surgical contraindications;no infection in operation region.\n* Be diagnosed with DM for at least 1 year.\n\nExclusion Criteria:\n\n* Refuse random treatment.\n* Previous operations on the target artery.\n* Acute lower extremity arterial thrombosis.\n* Serious major organ failure.\n* Allergic to the contrast agent or has contrast nephropathy.\n* No clinical compliance or unfit to join the trial'}, 'identificationModule': {'nctId': 'NCT01173094', 'acronym': 'DCLI-II', 'briefTitle': 'Optimized Strategy for Diabetic Patients With Critical Limb Ischemia(Part II) (DCLI-II)', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'DCLI-II:Optimized Strategy for Diabetic Patients With Critical Limb Ischemia: A Multi-center, Randomized Controlled Trial and Registration Study(Part II)', 'orgStudyIdInfo': {'id': 'pumch-DCLI-II'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PTA', 'description': 'The patients with short-obstruction in the below-knee artery will be included in this group.', 'interventionNames': ['Device: Percutaneous Transluminal Angioplasty']}, {'type': 'EXPERIMENTAL', 'label': 'bypass', 'description': 'The patients with long-obstruction in the below-knee artery will be included in this group.', 'interventionNames': ['Device: below-knee arterial bypass']}], 'interventions': [{'name': 'Percutaneous Transluminal Angioplasty', 'type': 'DEVICE', 'description': 'Before operation, take aspirin 100mg every day. During the operation, balloon is delivered by a catheter and positioned through the narrowing in the artery. Then expand the balloon against the wall of the blood vessel to provide a wider channel for blood.', 'armGroupLabels': ['PTA']}, {'name': 'below-knee arterial bypass', 'type': 'DEVICE', 'description': 'Before operation, take aspirin 100mg every day. Perform bypass to below-knee(posterior tibial，anterior tibial or peroneal)arteries, saphenous vein graft with end to side anastomoses', 'armGroupLabels': ['bypass']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100032', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Xuanwu Hospital, Beijing', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': 'Beijing', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Tongren Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Liu changwei, bachelor', 'role': 'STUDY_CHAIR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Tongren Hospital', 'class': 'OTHER'}, {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vascular Surgery', 'investigatorFullName': 'Liu Chang-wei', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}