PRG Combined With Autologous BMMSCs for Treatment of Diabetic Foot Ulcer
- Conditions
- Diabetic Foot Ulcer
- Interventions
- Biological: PRG combined with BMMSCs transplantation
- Registration Number
- NCT03248466
- Lead Sponsor
- Third Military Medical University
- Brief Summary
To investigate the treatment effect between Traditional treatment and transplantation of autologous PRG combined with autologous BMMSCs for treatment of diabetic foot ulcer.
- Detailed Description
60 diabetic foot ulcer in our hospital will divide into 3 groups: group A (20 diabetic foot ulcer who give Traditional treatment), group B (20 diabetic foot ulcer who give Traditional treatment and transplantation of autologous platelet rich gel)，group C (20 diabetic foot ulcer who give Traditional treatment and transplantation of autologous platelet rich gel combined with autologous bone marrow mesenchymal stem cells). The age, height, weight, blood glucose, glycosylated hemoglobin A1c（HbA1c）, lipid, blood pressure, course of disease, Wound healing rate,transcutaneous oxygen pressure,Amputation rate,Hospital stay will record respectively. And High-sensitive C-reactive protein (HsCRP) and Tumor necrosis factor-α（TNF-α） will detect as Baseline. After each group's treatment, Change from baseline of all indexes will record, one way Analysis of Variance will be analyzed the significantion among 3 groups.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- Diabetic foot according to The Wagner is 2-3 graded;
- Type 1 diabetes mellitus,presence of autoimmune diabetes;
- Gestational diabetes;
- Patients with heart, liver, or renal function impairment;presence of severe infections or cerebrovascular disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PRG combined with BMMSCs transplantation PRG combined with BMMSCs transplantation Traditional treatment such as insulin,antidiabetes,dressing and Autologous PRG combined with BMMSCs Traditional treatment PRG combined with BMMSCs transplantation Traditional treatment such as insulin,antidiabetes,dressing
- Primary Outcome Measures
Name Time Method Amputation rate up to 6 months Amputation rate up to 6 months
hospital stay up to 6 months hospital stay
- Secondary Outcome Measures
Name Time Method Wound healing time up to 6 months Wound healing time
Transcutaneous oxygen partial pressure Transcutaneous oxygen partial pressure up to 6 months Transcutaneous oxygen partial pressure
Trial Locations
- Locations (2)
Southwest Hospital of the Third Military Medical University
🇨🇳Chongqing, Chongqing, China
Endocrine Department, the First Affiliated Hospital of the Third Military Medical University
🇨🇳Chongqing, Chongqing, China