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

Diabetes Clinical Trial

Official title: DCLI-II:Optimized Strategy for Diabetic Patients With Critical Limb Ischemia: A Multi-center, Randomized Controlled Trial and Registration Study(Part II)

Status Enrolling by invitation

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.

Clinical Trial 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. ;

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

• NCT number: NCT01173094
• Study type: Interventional
• Source: Peking Union Medical College Hospital
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: August 2010
• Completion date: July 2016