A prospective, randomized study to compare the effect on tissue oxygenation and clinical outcome of autologous bone marrow-derived mononuclear cell therapy with standard treatment in patients with critical limb ischemia and diabetic foot not eligible for standard revascularization

Institut klinické a experimentální medicíny0 个研究点目标入组 40 人开始时间: 2016年4月14日最近更新: 2024年9月9日

试验速览

暂无简介。

•To include int the study the following criteria must be fullfilled:
•1.diabetic foot disease (DFD; ulcer distal from ankle) or status after minor amputation, in accordance with international classification TEXAS 2-3 (C-D), Wagner 2-4
•2.presence of chronic critical limb ischemia – ulcers or gangrene attributable to objectively proven arterial occlusive disease (transcutaneous oxygen pressure TcPO2 under 35 mm Hg), non-eligibility for standard revascularization (PTA or by-pass)
•3.age 18-90 years
•4.diabetes mellitus type 1 or 2
•5.signed informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•Patients who fullfilled one of these criteria will be excluded:
•1.severe active deep infection of DFD
•2.deep vein thrombosis less than 6 months
•3.severe limb oedema that rule out intramuscular injection of cell suspension
•4.severe non-treated diabetic retinopathy requiring acutely a laser therapy
•5.severe haematological disease
•6.diagnosed neoplastic process of any organ
•7.expected life prognosis shorter than 6 months
•8.contracindication of general anestesia
•9.females of childbearing potential must be willing 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.

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