Diabetes, Vascular Diseases
Conditions
Keywords
Critical limb ischemia, Diabetes Mellitus, Diabetes foot
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.
Interventions
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.
DEVICEbelow-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
Sponsors
Beijing Tongren Hospital
Xuanwu Hospital, Beijing
Peking Union Medical College Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occlusion of the below-knee artery or bypass | 36 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 30 days | 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 | 36 months | — |
| Procedural complications, defined as any adverse event | 36 months | including MI, DVT, hematoma, renal failure, wound infection, lymphatic fistula |
| Quality of Life assessment | 36 months | assessment in 1 month,6 months,12 months,24 months and 36 months post procedure |
| Restenosis measured by Duplex Ultrasound or CTA | 36 months | — |
Countries
China
Outcome results
None listed