Diabetes
Conditions
Interventions
Conventional treatment cohort:Standard treatment
Autologous fat microfragment transplantation treatment group:Autologous fat microfragment transplantation
Sponsors
The First Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years but = 1 cm^2 (after debridement, aim to remove necrotic, dead, and fibrous tissue as much as possible). If the patient has multiple lesions, one lesion must be selected as the qualifying lesion for certification and subsequent evaluation; 5. Standard treatment for diabetic foot ulcers with a wound area reduction of <= 20% in one week.
Exclusion criteria
Exclusion criteria: 1. Patients had a significant history of acute cardiovascular and cerebrovascular disease, such as acute myocardial infarction, severe angina pectoris, acute stroke, or transient ischemic attack, within 3 months before the study began; 2. Have severe uncontrolled hypertension, systolic blood pressure >= 180 mmHg or diastolic blood pressure >=110 mmHg at screening; 3. Patients with severe renal insufficiency (creatinine > 200µmol/L or creatinine clearance < 30 ml/min); 4. All types of diabetic coma; 5. Have had malignant tumors or suspected malignant tumors (general physical examination, abdominal ultrasound examination, chest X-ray, blood chemistry examination, etc.); 6. Patients with benign tumors at ulcer sites; 7. The patient has an immunocompromised disease, such as HIV. Use of drugs that can interfere with assessment: such as corticosteroids and immunosuppressants; 8. Pregnant women or lactating women, or male or female patients who plan to become pregnant during the study period and do not want to take contraceptive measures during treatment; 9. Patients whose health condition does not permit liposuction under local anesthesia; 10. Patients judged by the investigator to be unsuitable for clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skin healing rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time required for granulation formation >75%;Time required for complete skin healing;Rate of amputation and recurrence;Assessment of foot function; | — |
Countries
China
Contacts
Public ContactJing Hong
The First Affiliated Hospital of Wenzhou Medical Universit
Outcome results
None listed