refractory wound
Conditions
Interventions
Low dose group:The wound was treated with human umbilical cord mesenchymal stem cell gel (low concentration) for external use once a day for 6 days.
Medium dose group:The wound was treated with human umbilical cord mesenchymal stem cell gel (medium concentration) for external use once a day for 6 days.
High dose group:The wound was treated with human umbilical cord mesenchymal stem cell gel (high concentration) for external use once a day for 6 days.
Control group:The wound was treated with recombinant human epidermal growth factor gel for external use once a day for 6 days.
Sponsors
The First Medical Center of PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 (inclusive) -75 (inclusive); 2. Meet any one of the following diagnostic criteria for refractory wounds: (1). It conforms to the diagnostic criteria of refractory wounds after radiotherapy on the body surface, that is, local wounds were formed in tumor patients after radiotherapy, and the skin was damaged by radiation of degree III, which did not heal after one month of treatment; (2) It meets the diagnostic criteria of diabetic ulcer, that is, patients with type 1 or type 2 diabetes, with glycosylated hemoglobin HbA1c =3cm and =6cm^2 and =30mmHg, and the toe-brachial index (TBI) >= 0.5; 5. Women whose reproductive period or menopause time is less than 2 years (the urine pregnancy test of women of childbearing age is negative within 72 hours before starting the experiment) and agree to take effective non-drug contraceptive measures during the study period; 6. Patients with hypertension who have no new cardiovascular and cerebrovascular diseases within 6 months, including unstable angina pectoris, acute myocardial infarction, acute cerebral ischemia and cerebral infarction, and whose drug control has been stable can be enrolled in the group; 7. Read and fully understand the patient's instructions, agree to participate in this clinical trial, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with vascular ulcer with ankle-brachial index (ABI) less than 0.8, as well as body surface ulcer and recurrent aphthous ulcer caused by tumor, tuberculosis, syphilis and paraplegia; 2. Wound with obvious infection or necrosis; 3. Chronic eczema, severe hypoproteinemia, anemia (HB =160mmHg or diastolic blood pressure >= 100 mmHg; 8. Patients who are using immunosuppressants or anticoagulants; 9. Patients with abnormal liver and kidney function (ALT, AST>= 1.5 times the upper limit of normal value, Cr > the upper limit of normal value); 10. Those who have a history of stroke, unstable angina pectoris and myocardial infarction within 6 months; 11. Allergic to any component of therapeutic drugs or control drugs; 12. Pregnant, lactating women or those who have family planning recently; 13. Patients who have participated in any other clinical trials of new drugs within 3 months; 14. Any other factors that the researcher thinks are not suitable to participate in this experiment; 15. The wound is located at the big joint (such as elbow and knee) and needs to be treated with transfer flap.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound healing rate;Wound healing time;Clinical effectiveness of wound healing; | — |
Secondary
| Measure | Time frame |
|---|---|
| Related indicators of environmental change; | — |
Countries
China
Contacts
Public ContactLingli Guo
The First Medical Center of PLA General Hospital
Outcome results
None listed