The Efficacy and Safety of Umbilical Cord Blood Mononuclear Cell Gel in the Treatment of Refractory Diabetic Foot Ulcer.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Wound area reduction rate
研究概览
简要总结
Umbilical cord blood mononuclear cells (MNC) may improve the wound repair ability. This study aims to investigate the role of MNC in refractory diabetic foot ulcer by comparing the combination of PRP and MNC with PRP alone.
详细描述
The difficulty in the healing of diabetic foot is related to the loss of local repair microenvironment. The platelet rich plasma (PRP) can improve the repair ability, however, the requirement for wound bed preparation is strict, or treatment failure may occur. Umbilical cord blood mononuclear cells (MNC) may provide a better repair environment through paracrine action. This study aims to investigate the role of MNC in refractory diabetic foot ulcer by comparing the combination of PRP and MNC with PRP alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The age of the patients is 18-80 years old;
- •Diabetic foot is diagnosed and Wagner grade is above Ⅱ;
- •The duration of ulcer is 2 months or more, with no healing trend for 2 weeks or more.
- •Fasting blood glucose ≤ 9mmol / L, 2 hours postprandial blood glucose ≤ 13mmol / L;
- •The skin oxygen partial pressure around the wound is more than 20mmHg;
- •Sign written informed consent.
排除标准
- •Acute spreading infection of the wound, e.g. massive exudation, redness, swelling, heat, pain.
- •Acute myocardial infarction, heart failure, hepatitis;
- •Active bleeding or hematoma in the wound;
- •Serum albumin <25g/L;
- •Hemoglobin <80g/L;
- •Platelets <50×109/L;
- •Poor cooperate or compliance;The patient cannot cooperate or is.
- •Mentally disabled.
研究组 & 干预措施
MNC+PRP
The combination of PRP and MNC
干预措施: Umbilical cord blood mononuclear cell gel（MNC） (Drug)
MNC+PRP
The combination of PRP and MNC
干预措施: The platelet rich plasma（PRP） (Drug)
PRP
PRP alone.
干预措施: The platelet rich plasma（PRP） (Drug)
结局指标
主要结局
Wound area reduction rate
时间窗: one week
The ratio of the reduced area after one week of treatment to the original area
次要结局
- Wound healing rate at 4 weeks(4 weeks)
- Amputation rate at 8 weeks(8 weeks)
研究者
Long Zhang
Chief Surgeon
Peking University Third Hospital