In our study, the effect of autologous cell therapy (ACT) will be compared with repeated percutaneous transluminal angioplasty (re-PTA) in patients with diabetic foot and then will be compared the effect of combination treatment of ACT and re-PTA against re-PTA itself. We suppose an enhanced effect of this combination on on macro- and microcirculation. Expected results of the project include improved tissue oxygenation, enhanced DF healing and a reduced risk of major amputation. MedDRA version:
Conditions
Sponsors
Institut klinické a experimentální medicíny
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 2C-3D, Wagner 2-4 or ischemic rest pain 2. presence of chronic critical limb ischemia attributable to objectively proven arterial occlusive disease (TcPO2) under 40 mm Hg, indication for re-PTA 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the project is to compare the effect on tissue oxygenation and clinical outcome of autologous cell therapy with repeated PTA (re-PTA) in patients with diabetic foot disease (DFD) indicated for re-PTA.;Secondary Objective: Other objective is to compare the effect of combination treatment of cell therapy and re-PTA with re-PTA itself and to assess potential side effects of both methods.;Primary end point(s): 1.Comparison of both methods in several parameters: a)Assessment of tissue oxygenation – improvement of parameters of ischemia (measured by transcutaneous oxygen pressure) after injection of tested suspension in both BMMNC isolation methods in comparsion with baseline and after 3 months b)Clinical effect – wound healing, pain, major amputation ;Timepoint(s) of evaluation of this end point: Transcutaneous oxygen pressure and other parameters will be assessed after 1, 3 and 6 months after the ACT. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Safety: during and up to 6 months after the procedure Questionaries: after 1, 3 and 6 months after the procedure;Secondary end point(s): 1. Safety: adverse events – expected and unexpected 2. Assesment of study treatment by patients (psychological questionaries) | — |
Countries
Czech Republic
Contacts
Public ContactMUDr. Michal Dubský
Institute for Clinical and Experimental Medicine
Outcome results
None listed