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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Beijing Tongren Hospital
Xuanwu Hospital, Beijing
Information provided by (Responsible Party):
Liu Chang-wei, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01171703
First received: July 26, 2010
Last updated: December 20, 2012
Last verified: July 2010
  Purpose

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
Diabetes
Device: femoral-popliteal bypass
Device: stent
Phase 4

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Occlusion of the stent or bypass [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Procedural complications, defined as any adverse event [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
    including MI, DVT, hematoma, renal failure, wound infection, lymphatic fistula

  • Quality of Life assessment [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: November 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: bypass
femoral-popliteal bypass
Device: femoral-popliteal bypass
Before operation, take aspirin 100mg every day. Groin and suprageniculate incision, PTFE graft with end to side anastomoses.
Experimental: stent Device: stent
Before operation, take aspirin 100mg every day. During the operation, stent is delivered by a catheter and positioned through the narrowing in the artery. The stent is then expanded against the wall of the blood vessel to provide a wider channel for blood. At last, use balloon dilate the stent.

Detailed Description:

The trial includes two parts and here is part I. This part is a multi-center, prospective, randomized, controlled study to compare the therapeutic effect of stent and bypass to chronic long occlusion of the superficial femoral artery in DM patients. Totally 70 patients will be entered into the study. The lesion of the femoral artery should be TASC B、C or D and the patients should suffered ischemic symptom with Rutherford 3-6.The lesion does not extend beyond the aortoiliac artery or blow-knee popliteal artery, with at least 1 vessel infra-popliteal runoff to the foot.

  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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. The presentation is severe intermittent claudication, rest pain, ulcer or gangrene.
  • The lesion of the femoral artery should be TASC B、C or D.
  • The femoral-popliteal artery has never received bypass or endovascular therapy before.
  • No obvious stenosis or occlusion in the aortoiliac artery; or the lesion could be treated simultaneously or has already been cured.
  • No obvious stenosis in below-knee popliteal artery; at least 1 vessel infra-popliteal runoff to the foot.
  • 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 superficial femoral 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01171703

Locations
China, Beijing
Peking Union Medical College Hospital
Beijing, Beijing, China, 100032
Beijing Tongren Hospital
Beijing, Beijing, China, 100730
Xuanwu Hospital, Beijing
Beijing, Beijing, China, 100053
Sponsors and Collaborators
Peking Union Medical College Hospital
Beijing Tongren Hospital
Xuanwu Hospital, Beijing
Investigators
Study Chair: Liu changwei, bachelor
  More Information

Additional Information:
No publications provided

Responsible Party: Liu Chang-wei, Vascular Surgery, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01171703     History of Changes
Other Study ID Numbers: pumch-DCLI-I
Study First Received: July 26, 2010
Last Updated: December 20, 2012
Health Authority: China: Ministry of Health

Keywords provided by Peking Union Medical College Hospital:
Critical limb ischemia
Diabetes
Femoropopliteal artery bypass
Stent

Additional relevant MeSH terms:
Diabetes Mellitus
Ischemia
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 25, 2014