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

Primary Purpose

Vascular Diseases, Diabetes

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Percutaneous Transluminal Angioplasty
below-knee arterial bypass
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vascular Diseases focused on measuring Critical limb ischemia, Diabetes Mellitus, Diabetes foot

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking Union Medical College Hospital
  • Xuanwu Hospital, Beijing
  • Beijing Tongren Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PTA

bypass

Arm Description

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

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

Outcomes

Primary Outcome Measures

Occlusion of the below-knee artery or bypass

Secondary Outcome Measures

Mortality
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
Procedural complications, defined as any adverse event
including MI, DVT, hematoma, renal failure, wound infection, lymphatic fistula
Quality of Life assessment
assessment in 1 month,6 months,12 months,24 months and 36 months post procedure
Restenosis measured by Duplex Ultrasound or CTA

Full Information

First Posted
July 28, 2010
Last Updated
December 20, 2012
Sponsor
Peking Union Medical College Hospital
Collaborators
Beijing Tongren Hospital, Xuanwu Hospital, Beijing
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1. Study Identification

Unique Protocol Identification Number
NCT01173094
Brief Title
Optimized Strategy for Diabetic Patients With Critical Limb Ischemia(Part II) (DCLI-II)
Acronym
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

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
Beijing Tongren Hospital, Xuanwu Hospital, Beijing

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Diseases, Diabetes
Keywords
Critical limb ischemia, Diabetes Mellitus, Diabetes foot

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PTA
Arm Type
Experimental
Arm Description
The patients with short-obstruction in the below-knee artery will be included in this group.
Arm Title
bypass
Arm Type
Experimental
Arm Description
The patients with long-obstruction in the below-knee artery will be included in this group.
Intervention Type
Device
Intervention Name(s)
Percutaneous Transluminal Angioplasty
Intervention Description
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
Intervention Name(s)
below-knee arterial bypass
Intervention Description
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
Primary Outcome Measure Information:
Title
Occlusion of the below-knee artery or bypass
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Mortality
Description
The number of death during the first month after procedure, no matter whether the cause of death is related to the procedure.
Time Frame
30 days
Title
Rate of limb salvage
Time Frame
36 months
Title
Procedural complications, defined as any adverse event
Description
including MI, DVT, hematoma, renal failure, wound infection, lymphatic fistula
Time Frame
36 months
Title
Quality of Life assessment
Description
assessment in 1 month,6 months,12 months,24 months and 36 months post procedure
Time Frame
36 months
Title
Restenosis measured by Duplex Ultrasound or CTA
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liu changwei, bachelor
Official's Role
Study Chair
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
Xuanwu Hospital, Beijing
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Facility Name
Beijing Tongren Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
Beijing
Country
China

12. IPD Sharing Statement

Links:
URL
http://www.vascular.cn/
Description
the website of the vascular surgery department of PUMCH

Learn more about this trial

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

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