2024-512873-29-00招募中2 期
Efficacy of combined treatment by autologous cell therapy and percutaneous transluminal angioplasty (PTA) versus the treatment by isolated PTA in diabetic patients with chronic limb-threatening ischemia
Institute For Clinical And Experimental Medicine1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2025年2月25日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- rate of major amputation, wound healing, TcPO2
研究概览
简要总结
The aim of the clinical trial is to compare the effect of the combination of cell therapy and PTA with the effect of PTA alone and to assess possible side effects and complications of both methods. Primary: rate of major amputation, wound healing, TcPO2.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •diabetic foot ulcers (DFU; ulcer distal from ankle) or status after minor amputation, in accordance with international classification TEXAS 2C-3D, Wagner 2-4 or ischemic rest pain
- •presence of chronic limb-threatening ischemia attributable to objectively proven arterial occlusive disease; (TcPO2) under 40 mm Hg, indication for PTA
- •age 18-90 years
- •diabetes mellitus type 1 or 2
- •signed informed consent.
- •females of childbearing potential must be willing for the duration of the study to use a highly effective method of contraception (hormonal or barrier method of birth control; abstinence). Contraceptive methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods.
排除标准
- •severe active deep infection of DFU
- •breastfeeding women and women planning pregnancy at the time of the study
- •deep vein thrombosis less than 6 months
- •severe limb oedema that rule out intramuscular injection of cell suspension
- •severe non-treated diabetic retinopathy requiring acutely a laser therapy
- •severe haematological disease
- •diagnosed neoplastic process of any organ less than 5 years
- •expected life prognosis shorter than 6 months
- •contracindication of general anestesia
- •pregnant women – the test of pregnancy is the part of the examination before inclusion into the study
结局指标
主要结局
rate of major amputation, wound healing, TcPO2
rate of major amputation, wound healing, TcPO2
次要结局
- other ischemia parameteres – ABI, laser doppler flowmetry, magnetic resonance spectroscopy; optional: microbiopsy of the muscle of the foot
- other clinical effect – pain
- safety: adverse events – expected and unexpected
- assessment of quality of life (standardized questionnaires)
研究者
Michal Dubský
Scientific
Institute For Clinical And Experimental Medicine
研究点 (1)
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