Diabetic foot
Conditions
Interventions
Experimental group:Tibial Transverse Bone Transport
Control group:Acceptance of guidelines and standard methods (such as wound vacuum-assisted closure, two-stage skin grafting like flap transplantation, skin flap transplantation, etc., for treatment)
Sponsors
Affiliated Hospital of Guangdong Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age = 18 years; 2. Meet the diagnostic criteria for diabetes: fasting blood glucose level = 7.0 mmol/L, or oral glucose tolerance test, or postprandial blood glucose level > 11.1 mmol/L, or glycated hemoglobin (HbA1c) = 6.5%; 3. Severe diabetic foot patients, i.e., Texas Classification Grade II-III (ulcer involving tendon, joint capsule, bone, or joint cavity); 4. Ulcer location beyond the ankle joint, both initial and recurrent cases are eligible; 5. Ulcer area = 10cm2, or when multiple ulcers are present, at least one ulcer area should be = 10 cm2; 6. Willingness to participate in the study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. In the past 3 months, there have been new severe cardiovascular events such as heart failure, heart attack, severe arrhythmias, and stroke. 2. End-stage kidney disease with long-term blood purification treatment or serum creatinine clearance rate <30ml/min/1.73 m2. 3. Advanced cancer or other end-stage diseases with an expected survival period of less than 1 year. 4. Currently receiving cytotoxic drugs, corticosteroids, or other immunosuppressive treatments, or undergoing radiation and chemotherapy. 5. Coagulation disorders or poor general condition, unable to tolerate anesthesia and surgery. 6. Complicated with Charcot joint disease in the foot. 7. Severe peripheral vascular disease, popliteal artery stenosis =70%. 8. Soft tissue infection or tumor at the tibia surgery site, unable to undergo surgery. 9. History of limb revascularization surgery (endovascular treatment, reconstruction, or bypass) in the past 3 months. 10. Pregnancy or lactation period. 11. Complicated with mental disorders and unable to cooperate with treatment. 12. Currently participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amputation rate within 1 year; | — |
Secondary
| Measure | Time frame |
|---|---|
| 6-month ulcer healing rate;ulcer healing time;1-year recurrence rate of ulcers;Microvascular changes in the lower limbs;Ulcer foot muscle blood flow velocity and blood flow rate;ankle-brachial index;visual analogue scale;foot sensation;American Orthopaedic Foot & Ankle Society; | — |
Countries
China
Contacts
Public ContactGuanghua Chen
Affiliated Hospital of Guangdong Medical University
Outcome results
None listed