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

Optimized Strategy for Diabetic Patients With Critical Limb Ischemia: A Multi-center, Randomized Controlled Trial and Registration Study(Part I)

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.

Study Overview

• Status: Unknown
• Conditions: Vascular Diseases; Diabetes
• Intervention / Treatment: Device: stent; Device: femoral-popliteal bypass

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.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Beijing Tongren Hospital
    • Beijing, Beijing, China, 100053
      • Xuanwu Hospital, Beijing
    • Beijing, Beijing, China, 100032
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occlusion of the stent or bypass	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	The number of death during the first month after procedure, no matter whether the cause of death is related to the procedure.	30 days
Rate of limb salvage		36 months
Procedural complications, defined as any adverse event	including MI, DVT, hematoma, renal failure, wound infection, lymphatic fistula	36 months
Quality of Life assessment	assessment in 1 month,6 months,12 months,24 months and 36 months post procedure	36 months
Restenosis measured by Duplex Ultrasound or CTA		36 months

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: Xuanwu Hospital, Beijing; Beijing Tongren Hospital

Publications and helpful links

Helpful Links

• the website of the vascular surgery department of PUMCH

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Anticipated): July 1, 2013
• Study Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: July 26, 2010
• First Submitted That Met QC Criteria: July 27, 2010
• First Posted (Estimate): July 28, 2010

Study Record Updates

• Last Update Posted (Estimate): December 24, 2012
• Last Update Submitted That Met QC Criteria: December 20, 2012
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: Diabetes; Stent; Critical limb ischemia; Femoropopliteal artery bypass
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Ischemia
• Other Study ID Numbers: pumch-DCLI-I