Diabetic foot ulcers
Conditions
Interventions
control group:Debridement dressing
intervention group:Tibial transverse transport
Sponsors
the First affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 years old; 2. Meet the diagnostic criteria for diabetes: fasting blood glucose = 7.0 mmol/L or oral glucose tolerance test or 2 hours after meals blood glucose >11.1mmol/L or hemoglobin a1C (HbA1c) = 6.5%; 3. Patients with severe diabetic foot, i.e. Texas Scale ?-? (ulcer involving tendon, joint capsule, bone, or joint cavity); 4. The ulcer site is far from the ankle joint, the initial onset or recurrence can be; 5. Ulcer area =10cm^2; 6. Volunteer to participate in the study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. In the past 3 months, there were new serious cardiovascular and cerebrovascular adverse events, such as heart failure, myocardial infarction, severe arrhythmia, stroke, etc. 2. Patients with end-stage renal disease received blood purification therapy or serum creatinine clearance <30ml/min/ 1.73m^2 for a long time; 3. Advanced cancer or other end-stage diseases with an expected survival of less than 1 year; 4. Currently receiving cytotoxic drugs, glucocorticoids or other immunosuppressants, or receiving chemoradiotherapy; 5. Coagulation dysfunction or poor general general condition, unable to tolerate anesthesia and surgery; 6. Combined with Charcot arthropathy of the foot; 7. Severe peripheral vascular disease, popliteal artery stenosis = 70%; 8. There is a soft tissue infection or tumor in the operative site of the tibia, which cannot be operated on. 9. History of revascularization (endovascular therapy, reconstruction, or bridging) in the affected limb within the last 3 months; 10. Pregnancy or lactation; 11. Combined with mental disorders, unable to cooperate with treatment; 12. Who are participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ulcer healing rate at the sixth months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ulcer healing rate at the twelveh months;Amputation rate;Ulcer recurrence rate;Changes of lower extremity microvessels;Blood flow and blood volume in ulcerated foot muscles;Ankle-brachial pressure index;Foot pain;Foot sensation;Foot function; | — |
Countries
China
Contacts
Public ContactHua Qikai
the First Affiliated Hospital of Guangxi Medical University
Outcome results
None listed