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

Peking Union Medical College Hospital130 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

130

Conditions

Vascular Diseases Diabetes

Interventions

Percutaneous Transluminal AngioplastyDEVICE

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.

below-knee arterial bypassDEVICE

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

Eligibility

Sex: ALLMin age: 55 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (3)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Xuanwu Hospital, Beijing

Beijing, Beijing Municipality, China

Beijing Tongren Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Occlusion of the below-knee artery or bypass

Time frame: 36 months

Secondary Outcomes

Mortality

The number of death during the first month after procedure, no matter whether the cause of death is related to the procedure.

Time frame: 30 days

Rate of limb salvage

Time frame: 36 months

Procedural complications, defined as any adverse event

including MI, DVT, hematoma, renal failure, wound infection, lymphatic fistula

Time frame: 36 months

Quality of Life assessment

assessment in 1 month,6 months,12 months,24 months and 36 months post procedure

Time frame: 36 months

Restenosis measured by Duplex Ultrasound or CTA

Time frame: 36 months

Data from ClinicalTrials.gov

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