Diabetic foot disease
Conditions
Interventions
control group:percutaneous transluminal angioplasty
experiemental group:Ilizarov transverse tibial bone transport
Sponsors
Beijing Chaoyang Hospital of Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Patients who meet the diagnostic criteria of diabetes (fasting blood glucose >= 7.0 mmol / L, or postprandial 2-hour blood glucose >= 11.1 mmol / L or random blood glucose >= 11.1 mmol / L) 2. Patients with diabetic foot disease, and Wagner grade 2 or above (deep ulcer infection, often accompanied by soft tissue inflammation, no abscess or bone infection); 3. Patients with 0.40 <= ankle brachial index (ABI) < 1.30; 4. Patients with stenosis and occlusion of inferior genicular artery indicated by vascular ultrasound or CTA. Angiography showed that at least one of the distal tibial arteries (anterior tibial artery, posterior tibial artery and peroneal artery) was unobstructed. 5. Patients with no stenosis or occlusion of more than 50% of the inflow tract (one of superficial femoral artery and external iliac artery). 6. Patients aged between 18 and 85 years; 7. Patients understand the purpose of the trial, volunteer and sign the informed consent, understand and accept the duration of the study, and are able and willing to comply with all requirements, including follow-up and evaluation.
Exclusion criteria
Exclusion criteria: 1. Patients with ulcer complicated with severe infection and uncontrollable infection; 2. Patients with hemorrhagic diseases; 3. Patients receiving glucocorticoid, immunosuppressive therapy and chemotherapy; 4. The general condition of the patients was poor and could not tolerate the operation; 5. Patients with creatinine > 150umol / L; 6. Patients with cerebral hemorrhage or myocardial infarction within 3 months before the first operation; 7. Patients who had undergone lower extremity arterial surgery or systemic thrombolysis within 6 weeks; 8. Patients who have received any major surgical operation or interventional treatment within 30 days before operation; 9. Patients with bilateral lower limbs need to be intervened in the same hospitalization; 10. Patients who had undergone bypass surgery or stent implantation on the affected limb in the past; 11. Patients with sepsis or bacteremia; 12. Patients who underwent amputation (above ankle joint) on the study limb or non study limb; 13. Pregnant and lactating women; 14. Patients have other diseases, such as tumors, that may cause experimental difficulties or significantly shorten the patients' expected life. 15. Patients considered unsuitable for the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ankle-brachial index;restenosis rate;mortality;amputation rate; | — |
Countries
China
Contacts
Public ContactLi Chunming
Beijing Chaoyang Hospital Affiliated to Capital Medical University
Outcome results
None listed