Skin wound
Conditions
Interventions
Conventional drug therapy group:Conventional drug therapy
MSCs-EXOs group:MSCs-EXOs are injected subcutaneously
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subject and/or guardian is willing and able to sign the informed consent form; 2. Age 18~80 years old, clinically diagnosed with type 2 diabetes; 3. Diabetic foot ulcer Wagner grade 2; 4. The patient's fasting blood glucose was =0.6; 8. Good compliance, willing to follow the doctor's advice and able to conduct follow-up observation as required; 9. According to the medical history, physical examination and laboratory tests, the following requirements are met: the patient has no mental illness and no serious heart, lung or blood diseases.
Exclusion criteria
Exclusion criteria: 1. Patients with diabetic wound Wagner grade of 3~4; 2. Those who are allergic to the components of exosomes derived from human umbilical cord mesenchymal stem cells; 3. Refractory wounds with continuous wound opening for more than 4 months; 4. Patients with vascular lesions whose ankle-brachial index (ABI) is still less than 0.6 after treatment by various methods;? 5. Patients with grade 3 or 4 infection according to PEDIS classification; 6. Patients with malignant tumors such as cancerous ulcers, autoimmune ulcers, drug-induced ulcers, etc.; 7. Radioactive, systemic steroids, chemotherapy, immunosuppressants 3 weeks ago or during the trial; 8. The target ulcer has been treated with other special dressings within the last 7 days; 9. Severe malnutrition (hypoproteinemia, etc., albumin = 25 g/L); 10. Presence of hepatic and renal insufficiency, i.e., serum ALT and/or AST>120U/LBUN>9.0mmol/L, Crea>176umol/L; 11. Severe cardiopulmonary insufficiency or other chronic diseases that cannot tolerate treatment; 1?2. Pregnant or lactating women; 1?3. Patients who are mentally incapable or unable to understand the requirements to participate in the study; 14. Poor compliance, unwillingness or inability to follow instructions for postoperative therapy and/or rehabilitation protocols; 15. Participants who have participated in other clinical studies within 3 months prior to the start of this study; 16. Patients who are not suitable for enrollment in the opinion of other investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound healing rate;Effective;Positive rate of sweating test; | — |
Countries
China
Contacts
Public ContactCuiping Zhang
Chinese PLA General Hospital
Outcome results
None listed