Clinical trial NCT01173094: Optimized Strategy for Diabetic Patients With Critical Limb Ischemia(Part II) (DCLI-II)
Official title: DCLI-II:Optimized Strategy for Diabetic Patients With Critical Limb Ischemia: A Multi-center, Randomized Controlled Trial and Registration Study(Part II)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Vascular Diseases
Diabetes
Keywords: Critical limb ischemia
Diabetes Mellitus
Diabetes foot
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tongren Hospital
name: Xuanwu Hospital, Beijing
First posted: 2010-07-30
Enrollment: 130
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility 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.
* 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

Primary outcomes:
measure: Occlusion of the below-knee artery or bypass
timeFrame: 36 months
Secondary outcomes:
measure: Mortality
timeFrame: 30 days
measure: Rate of limb salvage
timeFrame: 36 months
measure: Procedural complications, defined as any adverse event
timeFrame: 36 months
measure: Quality of Life assessment
timeFrame: 36 months
measure: Restenosis measured by Duplex Ultrasound or CTA
timeFrame: 36 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Xuanwu Hospital, Beijing
state: Beijing
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
Study officials:
name: Liu changwei, bachelor
role: STUDY_CHAIR
References: