Diabetic foot ulcers
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Above 18 years old, below 70 years old; 2. Wagner grade >= ?grade; 3. DFUs patients meeting ALTPF indications, including wounds involving bone, tendon, blood vessels, nerves, and other important structures exposed; For DFUs patients with PAD, vascular revascularization or interventional therapy was followed by ALTPF; 4. Accept elective ALTPF reconstruction of DFUs and agree to participate in this clinical study.
Exclusion criteria
Exclusion criteria: 1. Patients with ASA grade IV or above and hemodynamic instability; 2. Severe systemic infection; 3. Hypovolemia; 4. EA or EDA or PCIA contraindications (such as ropivacaine allergy, epidural area infection, coagulation dysfunction, spinal malformation or history of previous surgery or trauma, spinal tuberculosis, central nervous system diseases, etc.); 5. End-stage renal disease (undergoing dialysis or serum creatinine > 2.5mg/dL or 221mmol/L); 6. Severe chronic obstructive pulmonary disease (GOLD >= stage III); 7. The subject participated in another clinical research trial within the past 30 days; 8. Pregnant women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain;Recipient complication; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mortality;amputation;Lower limb deep venous thrombosis;Pulmonary thromboembolism ;Maximal flow velocity of anastomosed artery;Postoperative pain assessment;Donor-site Complications;Complications of epidural anesthesia or PCEA;Number of secondary operations;Postoperative anticoagulant drugs;The operation time;Hospital stay;PCIA complications;mean arterial pressure(MAP);Intraoperative vasoactive drugs;Postoperative vasoactive drugs;Fluids given intraoperatively;Fluids given intraoperatively;Hospitalization expenses;Postoperative comfort of patients; | — |
Countries
China