Diabetic foot
Conditions
Interventions
Experimental group:Umbilical cord mesenchymal stem cell-derived exosome encapsulated hydrogel
Control group:Control hydrogel
Sponsors
The Third Affiliated Hospital Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Patients aged 18-60 years with type 2 diabetes mellitus according to the 1999 WHO diagnostic criteria; 2.Wagner1-2; 3.Wound size: between 2 and 10cm in diameter; 4.Signing Informed Consent;
Exclusion criteria
Exclusion criteria: 1.Clinically significant abnormal electrocardiogram, severe uncontrolled hypertension (systolic blood pressure >=180 mmHg or diastolic blood pressure >=110 mmHg), or symptomatic hypotension; history of cerebrovascular accident or transient ischemic attack; 2.Patients with definite relevant skin diseases that may prevent normal wound healing; 3.Immune dysfunction, HIV-infected patients, or those who have undergone radiation, systemic hormone therapy, chemotherapy, growth factor therapy, or immunosuppressive therapy within 1 month; 4.Patients diagnosed with malignant tumors or autoimmune diseases; 5.Participation in other clinical trials within 10 weeks; 6.Pregnancy or lactation; 7.Patients with definite psychiatric or psychological disorders; 8.Other serious concomitant diseases that the investigator considers inappropriate for inclusion;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diabetic foot wound healing rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Diabetes-related hospital length of stay and costs;Diabetic foot wound healing rate;Life quality;Wound area reduction percentage; | — |
Countries
China
Contacts
Public ContactYanming Chen
The Eighth Affiliated Hospital Sun Yat-sen University;Third Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed