Optimized Strategy for Diabetic Patients With Critical Limb Ischemia(Part II) (DCLI-II) (DCLI-II)
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|ClinicalTrials.gov Identifier: NCT01173094|
Recruitment Status : Unknown
Verified July 2010 by Liu Chang-wei, Peking Union Medical College Hospital.
Recruitment status was: Enrolling by invitation
First Posted : July 30, 2010
Last Update Posted : December 24, 2012
|Condition or disease||Intervention/treatment||Phase|
|Vascular Diseases Diabetes||Device: Percutaneous Transluminal Angioplasty Device: below-knee arterial bypass||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||DCLI-II:Optimized Strategy for Diabetic Patients With Critical Limb Ischemia: A Multi-center, Randomized Controlled Trial and Registration Study(Part II)|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||July 2013|
|Estimated Study Completion Date :||July 2016|
The patients with short-obstruction in the below-knee artery will be included in this group.
Device: Percutaneous Transluminal Angioplasty
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.
The patients with long-obstruction in the below-knee artery will be included in this group.
Device: below-knee arterial bypass
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
- Occlusion of the below-knee artery or bypass [ Time Frame: 36 months ]
- Mortality [ Time Frame: 30 days ]The number of death during the first month after procedure, no matter whether the cause of death is related to the procedure.
- Rate of limb salvage [ Time Frame: 36 months ]
- Procedural complications, defined as any adverse event [ Time Frame: 36 months ]including MI, DVT, hematoma, renal failure, wound infection, lymphatic fistula
- Quality of Life assessment [ Time Frame: 36 months ]assessment in 1 month,6 months,12 months,24 months and 36 months post procedure
- Restenosis measured by Duplex Ultrasound or CTA [ Time Frame: 36 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01173094
|Peking Union Medical College Hospital|
|Beijing, Beijing, China, 100032|
|Xuanwu Hospital, Beijing|
|Beijing, Beijing, China, 100053|
|Beijing Tongren Hospital|
|Beijing, Beijing, China, Beijing|
|Study Chair:||Liu changwei, bachelor|