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

Diabetes Clinical Trial

— 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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01173094
• Other study ID #: pumch-DCLI-II
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: July 28, 2010
• Last updated: December 20, 2012
• Start date: August 2010
• Est. completion date: July 2016

Study information

• Verified date: July 2010
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 130
• Est. completion date: July 2016
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Vascular Diseases

Intervention

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.
• 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

Locations

Country	Name	City	State
China	Beijing Tongren Hospital	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Xuanwu Hospital, Beijing	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Beijing Tongren Hospital, Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occlusion of the below-knee artery or bypass		36 months	No
Secondary	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	Yes
Secondary	Rate of limb salvage		36 months	Yes
Secondary	Procedural complications, defined as any adverse event	including MI, DVT, hematoma, renal failure, wound infection, lymphatic fistula	36 months	Yes
Secondary	Quality of Life assessment	assessment in 1 month,6 months,12 months,24 months and 36 months post procedure	36 months	Yes
Secondary	Restenosis measured by Duplex Ultrasound or CTA		36 months	No

External Links

•   the website of the vascular surgery department of PUMCH