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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Vascular Diseases, Diabetes

Intervention / Treatment
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* Device: Percutaneous Transluminal Angioplasty
* Device: below-knee arterial bypass


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PTA<br>The patients with short-obstruction in the below-knee artery will be included in this group. | Device: Percutaneous Transluminal Angioplasty<br>* 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.<br>|
| Experimental: bypass<br>The patients with long-obstruction in the below-knee artery will be included in this group. | Device: below-knee arterial bypass<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occlusion of the below-knee artery 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Critical limb ischemia, Diabetes Mellitus, Diabetes foot