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

NCT ID: NCT01173094

Last Updated: 2012-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2016-07-31

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.

Conditions

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Vascular Diseases Diabetes

Keywords

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Critical limb ischemia Diabetes Mellitus Diabetes foot

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PTA

The patients with short-obstruction in the below-knee artery will be included in this group.

Group Type EXPERIMENTAL

Percutaneous Transluminal Angioplasty

Intervention Type DEVICE

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.

bypass

The patients with long-obstruction in the below-knee artery will be included in this group.

Group Type EXPERIMENTAL

below-knee arterial bypass

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type 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

Intervention Type DEVICE

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
Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tongren Hospital

OTHER

Sponsor Role collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Liu Chang-wei

Vascular Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Liu changwei, bachelor

Role: STUDY_CHAIR

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status

Xuanwu Hospital, Beijing

Beijing, Beijing Municipality, China

Site Status

Beijing Tongren Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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pumch-DCLI-II

Identifier Type: -

Identifier Source: org_study_id