burns, chronic wounds
Conditions
Interventions
experimental group 1:Amniotic membrane micro-stent covering
experimental group 2:Skin and soft tissue expansion technique
control group 1:routine dressing
control group 2:conventional surgery(e.g. skin grafting)
Sponsors
The First Affiliated Hospital of Naval Medical University, PLA
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age from 18 to 80 years, regardless of gender; 2. Patients diagnosed with type II diabetic lower limb ulcer; 3. The affected limb has sufficient blood perfusion, ankle-brachial index 0.65-1.3, or transcutaneous oxygen partial pressure >40mmHg, Or Doppler ultrasound showed sufficient blood flow; 4. After debridement, the ulcer wound should be separated from the edge of other ulcers by at least 2 cm; 5. The wound area of ??the conservative dressing change group was 4cm2, the maximum distance between the skin on both sides of the wound edge <= 6cm; 6. Thorough debridement of the wound, no obvious necrotic tissue, infection control or osteomyelitis control; 7. The duration of the study ulcer wound at the time of enrollment visit is greater than 4 weeks and less than 52 weeks; 8. Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. The wound site cannot be covered and tightly attached with dressings; 2. Diabetes is poorly controlled (fasting blood glucose >= 8.0 mmol/L, or glycosylated hemoglobin HbA1c >= 9%); 3. The researcher believes that there is Factors that affect wound healing, such as the use of corticosteroids, immunosuppressants, and other drugs, chemotherapy or radiotherapy within one year; 4. Accept or plan to receive drugs or treatments, and researchers believe that these drugs or treatments will interfere or affect the wound Speed ??and quality of healing; 5. Unstable Charcot's foot, or Charcot's arthropathy causing bone protrusion; 6. Severe lymphedema, coagulopathy, autoimmune disease, cardiovascular and cerebrovascular disease, severe liver, lung and kidney Patients with disease; 7. Those who have received hyperbaric oxygen therapy within 5 days before enrollment, or who have received or plan to receive growth factor, tissue engineered skin or other skin substitute treatment within 30 days; 8. Participated in or are participating in other clinical trials within 30 days before screening Researchers; 9. Women who are pregnant or breast-feeding; 10. Cross-joint or poor general conditions are not suitable for external soft tissue expansion techniques; 11. Allergic to collagen materials; 12. Other situatioans which researchers think not suitable for entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| average wound healing time; | — |
Secondary
| Measure | Time frame |
|---|---|
| total wound closure rate;ulcer recurrence rate;medical fees;total days in hospital; | — |
Countries
China
Contacts
Public ContactShizhao Ji
Department of Burns, The First Affiliated Hospital of Naval Medical University, PLA
Outcome results
None listed