Critical ischemia of lower limbs in diabetic patients
Conditions
Sponsors
FUNDACION JIMENEZ DIAZ HEALTH RESEARCH INSTITUTE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients of both sexes. ? Age between 40 and 90 years. ? Type 2 diabetes established with more than 1 year since diagnosis. ? Severe grade vascular arteriosclerosis (category RB 4 and 5 mono or bilateral). ? Impossibility of surgical or endovascular revascularization or failure in revascularization surgery performed, at least 30 days before inclusion in the study, defining failure as direct non-arrival of vessels to the plantar arch. ? Normal biochemical parameters defined by: o Leukocytes> 3000 / mm3 o Neutrophils> 1500 / mm3 o Platelets> 100,000 / mm3 o AST / ALT =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ?CLI with tissue loss in the target member (category 6 of RB). ? Previous major amputation in the target member. ? Uncontrolled hypertension (defined as PAS> 180 or PAD> 110 in at least 2 determinations during the selection period). ? Patients with severe heart failure or ejection fraction less than 30%. ? Patients with a previous diagnosis of ventricular arrhythmias or unstable angina. ? Patients with septicemia. ? Patients diagnosed with deep vein thrombosis in the 3 months prior to their inclusion in the study. ? Concomitant therapy that includes hyperbaric oxygen, angiogenic agents or Cox II inhibitors. ? Contraindication to RMN. ? Proliferative retinopathy without treatment. ? Diabetic nephropathy in hemodialysis. ? Patients previously treated with cell therapy, gene therapy or growth factors in the last year. ? Concomitant disease that limits life expectancy to 1 year or that does not ensure the follow-up period. ? Patients who have suffered a stroke or myocardial infarction in the 3 months prior to the inclusion visit. ? Severe anemia (hemoglobin <7.9g / dl) in the inclusion analysis. ? Patients with a previous diagnosis of chronic alcoholism. ? Any clinically significant anomaly detected in the Selection Period and which, in the opinion of the investigator, constitutes an impediment to the correct participation of the patient in the study or the fulfillment of the procedures established therein.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of the administration of allogenic mesenchymal cells derived from adipose tissue in diabetic patients with critical ischemia of the lower limbs.;Secondary Objective: -To evaluate the preliminary efficacy of the treatment. - To evaluate the quality of life after the administration of the treatment.;Primary end point(s): According to the primary objective of the study, the following variables are defined: o Percentage and type of complications arising from treatment: o Complications during anesthesia. o Complications during cell implantation. o Peri and postoperative complications.;Timepoint(s) of evaluation of this end point: At 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Evaluation of perfusion NMR vascularization. ? Score on the Rutherford-Becker Scale at 3, 6 and 12 months (0 to 6) ? Presence of ulcers: at 3, 6 and 12 months ? WIfI classification ?Planimetry ? ITB measured at 3, 6 and 12 months. ? EVA scale measured at 3, 6, 12 months. ? Temperature at 3, 6 and 12 months. ? Perimetry at 3, 6 and 12 months. ? Neuropathic clinic measured at 3, 6 and 12 months. ? Amputations: yes / no. Tertiary endpoints: SF Score SF-12 VascuQol-6;Timepoint(s) of evaluation of this end point: All of them at baseline and 3, 6 and 12 months Vasculogenesis through MRI only at 12 months | — |
Countries
Spain
Contacts
Public ContactCLINICAL RESEARCH UNIT
FUNDACION JIMENEZ DIAZ HEALTH RESEARCH INSTITUTE
Outcome results
None listed