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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 4

Conditions: Diabetes; Vascular Diseases

Treatments: Device: Percutaneous Transluminal Angioplasty; Device: below-knee arterial bypass

Study type: Interventional

Funder types: Other

Identifiers

NCT01173094

pumch-DCLI-II

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 estimated patients

Sex: All

Ages: 55 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

PTA

Experimental group

Description:

The patients with short-obstruction in the below-knee artery will be included in this group.

Treatment:

Device: Percutaneous Transluminal Angioplasty

bypass

Experimental group

Description:

The patients with long-obstruction in the below-knee artery will be included in this group.

Treatment:

Device: below-knee arterial bypass