Transplantation of Autologous Platelet Rich Gel Combined With Autologous Bone Marrow Mesenchymal Stem Cells for Treatment of Diabetic Foot Ulcer
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Amputation rate
研究概览
简要总结
To investigate the treatment effect between Traditional treatment and transplantation of autologous PRG combined with autologous BMMSCs for treatment of diabetic foot ulcer.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetic foot according to The Wagner is 2-3 graded;
排除标准
- •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.
研究组 & 干预措施
Traditional treatment
Traditional treatment such as insulin,antidiabetes,dressing
干预措施: PRG combined with BMMSCs transplantation (Biological)
PRG combined with BMMSCs transplantation
Traditional treatment such as insulin,antidiabetes,dressing and Autologous PRG combined with BMMSCs
干预措施: PRG combined with BMMSCs transplantation (Biological)
PRG treatment
Traditional treatment such as insulin,antidiabetes,dressing and Autologous PRG
结局指标
主要结局
Amputation rate
时间窗: up to 6 months
Amputation rate up to 6 months
hospital stay
时间窗: up to 6 months
hospital stay
次要结局
- Wound healing time(up to 6 months)
- Transcutaneous oxygen partial pressure(Transcutaneous oxygen partial pressure up to 6 months)
研究者
Wu Qinan
Doctor
Third Military Medical University