Critical limb ischemia MedDRA version: 20.0 Level: LLT Classification code 10058069 Term: Critical limb ischemia System Organ Class: 100000004866
Conditions
Sponsors
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients able to walk - Male and female patients, aged 18-80 years - No-option CLI (definition: exhausted revascularization options including surgery or endovascular treatment) in Rutherford stage 4-5 - In case of bilateral N-O CLI, the limb with shorter claudication distance will be treated - Presence of adequate inflow (patent iliac and common femoral arteries) - Run-off through at least one (even partially seen) below-the-knee (BTK) artery - 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 115 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 115
Exclusion criteria
Exclusion criteria: - Malignancy - Moderate or severe immunodeficiency - Acute or chronic bacterial or viral infectious disease - Soft tissue disease or local infection in a place of required artery puncture - Pregnancy or breastfeeding - Any objective or subjective reason for inability to attend follow-up visits - Females of childbearing potential, who does not want to use a highly effective method of contraception - Females of childbearing potential who does not have a menstrual period confirmed and a negative highly sensitive urine or serum pregnancy test - Participation in any other clinical research study that has not reached the primary efficacy endpoint or otherwise would interfere with the patient’s participation in this project - Life expectancy < 1 year - Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the project
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the regeneration ischemia cardiovascular system in critical limb ischemia without the possibility of revascularization (N-O CLI) by treatment with CardioCell.;Secondary Objective: Assess the efectiveness of the use of the product on the basis of the increase walking distance without pain, assessed at thye main hospitalization and at 6 month follow-up beetween two groups (active vs sham).;Primary end point(s): Change in pain-free walking distance (6M FU vs index evaluation) between two groups (active vs placebo therapy).;Timepoint(s) of evaluation of this end point: 6 and 12 months Follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 3, 6 and 12 months follow-up;Secondary end point(s): 1. Amputation-free survival period evaluation of treated leg at 6 month and 1 year FU. 2. Ulcer-free survival (in patients without ulceration at baseline evaluation) and ulcer-extension free survival (in patients with ulceration in the beginning of the trial) of treated leg in period evaluation at 6 month and 1 year FU. 3. Change in tissue oxygen/CO2 tension, assessed by NIRS method at each trial evaluation point. 4. An improvement of tissue perfusion assessed in MRI at each trial evaluation point. 5. Change in transcutaneous pressure of O2 (tcpO2) between two groups (active vs placebo therapy) at each trial evaluation point. 6. Change in ABI score at each trial evaluation point. 7. Quality of life improvement, assessed by SF-36 v2 questionnaire or other dedicated for investigated population at each trial evaluation point. | — |
Countries
Poland
Contacts
Public ContactClinical Trial Information Desk
Ewa Gasior
Outcome results
None listed