NCT01171703.
| Trial name or title | Optimized strategy for diabetic patients with critical limb ischaemia: a multi‐center, randomised controlled trial and registration study (Part 1) |
| Methods | Allocation: randomised Endpoint classification: safety/efficacy study Intervention model: parallel assignment Masking: open label Primary purpose: treatment |
| Participants | Diabetic individuals with CLI |
| Interventions | Femoro‐popliteal bypass above the knee with PTFE graft Stenting of the SFA |
| Outcomes | Primary outcome measures: occlusion of the stent or bypass Secondary outcome measures: mortality, rate of limb salvage, procedural complications, quality of life assessment, re‐stenosis |
| Starting date | November 2010 |
| Contact information | Liu Chang‐wei, Vascular Surgery, Peking Union Medical College Hospital, Beijing, China, 100032 |
| Notes |
NCT01171703 Sponsors and Collaborators: Peking Union Medical College Hospital; Beijing Tongren Hospital; Xuanwu Hospital; Beijing |