Critical limb ischemia Circulatory System Critical limb ischemia
Conditions
Interventions
Participants are randomised into two groups by computer randomization program (local IM BMCs administration versus selective IA infusion, 1:1) with equal sex distribution and equal distribution of pat
Sponsors
National Institute of Heart and Vascular Diseases
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients over 18 years of age 2. With ischemic skin lesions (ulcers or gangrene) with a Critical limb ischemia Rutherford category of 5 or 6 according to the TransAtlantic InterSociety Consensus (TASC) classification (minor or major tissue loss) 3. Critical limb ischemia defined by ankle–brachial index =0.4, or ankle systolic pressure <50 mmHg, or toe systolic pressure <30 mmHg, or transcutaneous oxygen pressure (tcpO2) <30 mmHg 4. No option for endovascular or surgical revascularization assessed by a vascular surgeon and interventionalist 5. Failed revascularization defined as no change of clinical status with the best standard care 4 weeks after endovascular or surgical revascularization
Exclusion criteria
Exclusion criteria: 1. Life expectancy <6 months 2. Evidence of malignancy during last 5 years 3. Proliferative retinopathy 4. Critical coronary artery disease or unstable angina pectoris 5. End-stage kidney disease and patient on dialysis 6. Bone-marrow disease (e.g., myelodysplastic syndrome, severe anemia, leukopenia, thrombocytopenia)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combined end-point of limb salvage and wound healing is measured at 12 months. Wound characteristics are documented by digital photography. Wound healing is evaluated by two independent physicians. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mortality is assessed at 12 months follow-up. In case of absence of patients at regular follow-up control, the family of patient is contacted. 2. Amputation free survival is measured by clinical assessment at 12 months. 3. Major limb amputation rate is measured by clinical assessment at 12 months. 4. Limb perfusion is determined by measuring transcutaneous oxygen pressure (tcpO2) of the affected limb at baseline, 6 months, and 12 months. TcpO2 is measured using a TCM400 Mk2 monitor (Radiometer Medical ApS, Copenhagen, Denmark), at the forefoot in the supine position with an electrode temperature of 44°C. 5. Severity of limb ischemia is determined using the Rutherford classification at baseline, 6 months, and 12 months. 6. Severity of limb ischemia is determined using the ankle brachial index (ABI) assessment at baseline, 6 months, and 12 months. Measurement of the resting ankle–brachial index (ABI) is realized according to validated standards. It is calculated as the quotient of the highest ankle pressure and highest brachial systolic blood pressure (normal values, 0.95–1.2). 7. Pain scale is measured using a visual analog scale (VAS) graded form 0 to 10, at baseline, 6 months, and 12 months 8. Quality of life at 6 months and 12 months after BMC application is assessed by the EuroQol questionnaire. Using a VAS, patients rate their overall health status from 0 (“worst”) to 100 (“best”) imaginable health. 9. Wound size is measured in cm2 at baseline, 6 months, and 12 months. Wound characteristics are documented by digital photography. Wound healing is evaluated by two independent physicians. | — |
Countries
Slovakia
Outcome results
None listed