Optimized Strategy for Diabetic Patients With Critical Limb Ischemia(Part I) (DCLI-I)
This study is not yet open for participant recruitment.
Verified July 2010 by Peking Union Medical College Hospital
Sponsor:
Peking Union Medical College Hospital
Collaborators:
Beijing Tongren Hospital
Xuanwu Hospital, Beijing
Information provided by:
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01171703
First received: July 26, 2010
Last updated: July 27, 2010
Last verified: July 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Vascular Diseases Diabetes |
Device: femoral-popliteal bypass Device: stent |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Optimized Strategy for Diabetic Patients With Critical Limb Ischemia: A Multi-center, Randomized Controlled Trial and Registration Study(Part I) |
Resource links provided by NLM:
Further study details as provided by Peking Union Medical College Hospital:
Primary Outcome Measures:
- Occlusion of the stent or bypass [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]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 [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
- Procedural complications, defined as any adverse event [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]including MI, DVT, hematoma, renal failure, wound infection, lymphatic fistula
- Quality of Life assessment [ Time Frame: 36 months ] [ Designated as safety issue: No ]assessment in 1 month,6 months,12 months,24 months and 36 months post procedure
- Restenosis measured by Duplex Ultrasound or CTA [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 70 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | July 2016 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: bypass
femoral-popliteal bypass
|
Device: femoral-popliteal bypass
Before operation, take aspirin 100mg every day. Groin and suprageniculate incision, PTFE graft with end to side anastomoses.
|
| Experimental: stent |
Device: stent
Before operation, take aspirin 100mg every day. During the operation, stent is delivered by a catheter and positioned through the narrowing in the artery. The stent is then expanded against the wall of the blood vessel to provide a wider channel for blood. At last, use balloon dilate the stent.
|
Detailed Description:
The trial includes two parts and here is part I. This part is a multi-center, prospective, randomized, controlled study to compare the therapeutic effect of stent and bypass to chronic long occlusion of the superficial femoral artery in DM patients. Totally 70 patients will be entered into the study. The lesion of the femoral artery should be TASC B、C or D and the patients should suffered ischemic symptom with Rutherford 3-6.The lesion does not extend beyond the aortoiliac artery or blow-knee popliteal artery, with at least 1 vessel infra-popliteal runoff to the foot.
Eligibility| Ages Eligible for Study: | 55 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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. The presentation is severe intermittent claudication, rest pain, ulcer or gangrene.
- The lesion of the femoral artery should be TASC B、C or D.
- The femoral-popliteal artery has never received bypass or endovascular therapy before.
- No obvious stenosis or occlusion in the aortoiliac artery; or the lesion could be treated simultaneously or has already been cured.
- No obvious stenosis in below-knee popliteal artery; at least 1 vessel infra-popliteal runoff to the foot.
- 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 superficial femoral 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01171703
Contacts
| Contact: Zheng yuehong, doctor | 86-010-88068230 | yuehongzheng@yahoo.com |
| Contact: Chen yu, doctor | 86-010-88068230 | pkuwz2000@yahoo.cm.cn |
Locations
| China, Beijing | |
| Peking Union Medical College Hospital | Not yet recruiting |
| Beijing, Beijing, China, 100032 | |
| Contact: Zheng yuehong, doctor 86-010-88068230 yuehongzheng@yahoo.com | |
| Contact: Chen yu, doctor 86-010-88068230 pkuwz2000@yahoo.com.cn | |
| Principal Investigator: Song xiaojun, doctor | |
| Sub-Investigator: Chen yu, doctor | |
| Beijing Tongren Hospital | Not yet recruiting |
| Beijing, Beijing, China, 100730 | |
| Contact: Yu zhengya, doctor zhengyayu@yahoo.com | |
| Principal Investigator: Yu zhengya, doctor | |
| Xuanwu Hospital, Beijing | Not yet recruiting |
| Beijing, Beijing, China, 100053 | |
| Contact: Gu yongquan, doctor gu-yq@263.net | |
| Principal Investigator: Gu yongquan, doctor | |
Sponsors and Collaborators
Peking Union Medical College Hospital
Beijing Tongren Hospital
Xuanwu Hospital, Beijing
Investigators
| Study Chair: | Liu changwei, bachelor |
More Information
Additional Information:
No publications provided
| Responsible Party: | Zheng yuehong, Peking Union Medical College Hospital |
| ClinicalTrials.gov Identifier: | NCT01171703 History of Changes |
| Other Study ID Numbers: | pumch-DCLI-I |
| Study First Received: | July 26, 2010 |
| Last Updated: | July 27, 2010 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Peking Union Medical College Hospital:
|
Critical limb ischemia Diabetes Femoropopliteal artery bypass Stent |
Additional relevant MeSH terms:
|
Diabetes Mellitus Ischemia Vascular Diseases Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Pathologic Processes Cardiovascular Diseases |
ClinicalTrials.gov processed this record on October 17, 2012
