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

Overview

No summary available.

Registry

who.int

Start Date

April 14, 2016

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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

•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.