diabetic foot
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years. 2. Wagner grade 2 or 3 diabetic foot. 3. After debridement, ulcers on the back of the foot, sole and calcaneus are greater than or equal to 2cm^2.
Exclusion criteria
Exclusion criteria: 1. Ankle-brachial index 1.2. 2. Patients with ulcers caused by electric shocks, chemical burns, radiation, etc. 3. Patients with malignant ulcers. 4. Patients diagnosed with Charcot disease. 5. Patients suffering from collagen vascular disease. 6. Patients whose blood sugar is out of control (A1C>12%). 7. Patients who have used hyperbaric oxygen therapy to treat ulcers. 8. Patients using glucocorticoids, immunosuppressants or undergoing chemotherapy. 9. Patients who have used recombinant or autologous growth factor products. 10. Patients who have used substitutes for epidermis or dermis. 11. The patient has used any stem cell preparations in the past. 12. Suffer or have had cancer or tumor. 13. There are any other medical conditions that cannot participate in the study, including contraindications to MRI, such as pacemakers. 14. Pregnancy. 15. Body mass index (BMI)> 40 kg / m^2. 16. Unable to complete the 12-month study follow-up. 17. Cannot understand written and spoken Chinese. 18. Have any history of mental or mental illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ulcer healing rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Whether a minor amputation or major amputation occurred;Improvement of blood supply in the foot;Improvement of foot neuropathy;Change in ulcer area; | — |
Countries
China
Contacts
Shanghai Jiaotong University Affiliated Sixth People's Hospital