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

Phase 4

• Conditions: Vascular Diseases; Diabetes
• Interventions: Device: Percutaneous Transluminal Angioplasty; Device: below-knee arterial bypass

• Registration Number: NCT01173094
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Status Verified: 2010-07
• Study First Submitted: 2010-07-28
• Study First Submitted QC: 2010-07-28
• Study First Posted: 2010-07-30
• Study Start: 2010-08
• Last Update Submitted: 2012-12-20
• Last Update Posted: 2012-12-24
• Primary Completion: 2013-07
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PTA	Percutaneous Transluminal Angioplasty	The patients with short-obstruction in the below-knee artery will be included in this group.
bypass	below-knee arterial bypass	The patients with long-obstruction in the below-knee artery will be included in this group.

Primary Outcome Measures

Name	Time	Method
Occlusion of the below-knee artery or bypass	36 months

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Xuanwu Hospital, Beijing; 🇨🇳 Beijing, Beijing, China

Beijing Tongren Hospital; 🇨🇳 Beijing, Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China