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Optimized Strategy for Diabetic Patients With Critical Limb Ischemia(Part II) (DCLI-II) (DCLI-II)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by Peking Union Medical College Hospital.
Recruitment status was:  Enrolling by invitation
Beijing Tongren Hospital
Xuanwu Hospital, Beijing
Information provided by (Responsible Party):
Liu Chang-wei, Peking Union Medical College Hospital Identifier:
First received: July 28, 2010
Last updated: December 20, 2012
Last verified: July 2010
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.

Condition Intervention Phase
Vascular Diseases
Device: Percutaneous Transluminal Angioplasty
Device: below-knee arterial bypass
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: DCLI-II:Optimized Strategy for Diabetic Patients With Critical Limb Ischemia: A Multi-center, Randomized Controlled Trial and Registration Study(Part II)

Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • Occlusion of the below-knee artery or bypass [ Time Frame: 36 months ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 130
Study Start Date: August 2010
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PTA
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.
Experimental: bypass
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

Detailed Description:
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.

Ages Eligible for Study:   55 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • The patients volunteer to join the trial and sign the formal consent.
  • The patients are ≥55 year-old and ≤75 year-old.
  • The patients suffer from symptomatic leg ischemia with rutherford classification3, 4 , 5 or 6.
  • Obvious stenosis or occlusion in below-knee popliteal artery
  • No obvious stenosis or occlusion in the aortoiliac artery; or the lesion could be treated simultaneously or has already been cured.
  • No surgical contraindications;no infection in operation region.
  • Be diagnosed with DM for at least 1 year.

Exclusion Criteria:

  • Refuse random treatment.
  • Previous operations on the target artery.
  • Acute lower extremity arterial thrombosis.
  • Serious major organ failure.
  • Allergic to the contrast agent or has contrast nephropathy.
  • No clinical compliance or unfit to join the trial
  Contacts and Locations
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Please refer to this study by its identifier: NCT01173094

China, Beijing
Peking Union Medical College Hospital
Beijing, Beijing, China, 100032
Xuanwu Hospital, Beijing
Beijing, Beijing, China, 100053
Beijing Tongren Hospital
Beijing, Beijing, China, Beijing
Sponsors and Collaborators
Peking Union Medical College Hospital
Beijing Tongren Hospital
Xuanwu Hospital, Beijing
Study Chair: Liu changwei, bachelor
  More Information

Additional Information:
Responsible Party: Liu Chang-wei, Vascular Surgery, Peking Union Medical College Hospital Identifier: NCT01173094     History of Changes
Other Study ID Numbers: pumch-DCLI-II
Study First Received: July 28, 2010
Last Updated: December 20, 2012

Keywords provided by Peking Union Medical College Hospital:
Critical limb ischemia
Diabetes Mellitus
Diabetes foot

Additional relevant MeSH terms:
Vascular Diseases
Pathologic Processes
Cardiovascular Diseases processed this record on April 28, 2017