Chronic wounds
Conditions
Interventions
Fresh allogeneic cell sheet group:Covering fresh cell sheet group
Lyophilized allogeneic cell sheet group:Covering lyophilized cell sheet group
Sponsors
Chinese People's Liberation Army General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years, no gender restriction; 2. Chronic wound duration =4 weeks and =52 weeks; 3. Wound types include but are not limited to: diabetic foot ulcer (Wagner grade 1–3), venous leg ulcer, pressure injury (stage 2–4), post-traumatic or postoperative chronic non-healing wound; 4. Wound bed is suitable for grafting: no active infection after debridement, no exposure of major blood vessels, tendons, or bones, or if exposed, there remains a granulation tissue bed suitable for grafting; 5. Lower extremity vascular function assessment: ankle–brachial index (ABI) >=0.6 or transcutaneous oxygen pressure (TcPO2)>=30 mmHg, or improved blood flow following endovascular intervention; 6. The patient or their legally authorized representative has provided informed consent, agrees to receive allogeneic cell sheet transplantation, and is willing to complete follow-up according to the study protocol.
Exclusion criteria
Exclusion criteria: 1. Presence of uncontrolled severe infection, necrotic tissue, or osteomyelitis in the wound; 2. Active bleeding or coagulopathy; 3. Known allergy to cell culture components (e.g., bovine serum, trypsin, etc.); 4. Poor general condition, multiple organ failure, severe systemic infection, or severe wound infection; 5. Severe hepatic or renal insufficiency, malignancy, autoimmune disease, history of organ transplantation, or long-term use of high-dose glucocorticoids/immunosuppressants; history of allergy or hypersensitivity to penicillin or streptomycin; positive for human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or syphilis; 6. Poorly controlled diabetes (HbA1c > 10%); 7. Pregnancy or lactation; 8. Concurrent participation in another interventional clinical trial; 9. Other conditions deemed by the investigator to preclude compliance with follow-up or completion of the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete wound closure time;Scar quality; | — |
Secondary
| Measure | Time frame |
|---|---|
| Wound closure rate;change in pain score; | — |
Countries
China
Contacts
Public ContactChuanan Shen
Chinese People's Liberation Army General Hospital
Outcome results
None listed