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

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

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.

Study Overview

• Status: Unknown
• Conditions: Vascular Diseases; Diabetes
• Intervention / Treatment: Device: Percutaneous Transluminal Angioplasty; Device: below-knee arterial bypass

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 Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Xuanwu Hospital, Beijing
    • Beijing, Beijing, China, 100032
      • Peking Union Medical College Hospital
    • Beijing, Beijing, China, Beijing
      • Beijing Tongren Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: Xuanwu Hospital, Beijing; Beijing Tongren Hospital

Publications and helpful links

Helpful Links

• the website of the vascular surgery department of PUMCH

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Anticipated): July 1, 2013
• Study Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: July 28, 2010
• First Submitted That Met QC Criteria: July 28, 2010
• First Posted (Estimate): July 30, 2010

Study Record Updates

• Last Update Posted (Estimate): December 24, 2012
• Last Update Submitted That Met QC Criteria: December 20, 2012
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Critical limb ischemia; Diabetes foot
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Ischemia
• Other Study ID Numbers: pumch-DCLI-II