Leprosy Ulcer
Conditions
Interventions
Treatment group:Autologous stromal vascular fraction grafting treatment
Control group:Local saline injection treatment
Sponsors
Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences, Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Patients who meet all of the following inclusion criteria are eligible for enrollment in this study: 1. Age >=18 and <=80 years old, male or female; 2. Meet the diagnostic criteria for leprosy chronic ulcer refractory wounds, and the wound has not healed after 3 months of treatment; 3. The area of a single wound is measurable, and the ulcer diameter is less than 10 cm and the depth is less than 3 cm; 4. Can complete the treatment according to the grouping requirements, have complete clinical data, and have passed the review of the Ethics Committee of the Hospital for Skin Diseases, Chinese Academy of Medical Sciences.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from this study: 1. Patients with malignant tumors, severe liver and kidney dysfunction, autoimmune diseases, or severe infections; 2. Severe deep infection of the wound or severe vascular obstruction; 3. Patients who cannot obtain autologous stromal vascular fraction and have not received local injection; 4. Patients who cannot obtain effective Visual Analogue Score (VAS) and quantitative wound score; 5. Patients with mental illness; 6. Personnel who are simultaneously participating in other studies; 7. Researchers believe that there are other reasons that make them unsuitable to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with complete (100%) ulcer healing at 8 weeks after autologous stromal vascular fraction injection; | — |
Secondary
| Measure | Time frame |
|---|---|
| Inflammation status and collagen content of the local ulcer after transplantation;Analysis of neurotrophic factor expression levels in ulcerated tissue;Dynamic observation of cell content at different time points;Incidence of local adverse reactions at the injection site;Incidence of systemic adverse events; | — |
Countries
the People's Republic of China
Contacts
Public ContactHongsheng Wang
Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences, Peking Union Medical College
Outcome results
None listed