Phase II national, multicenter, double-blind, randomized, placebo-controlled, phase-3 clinical trial of 3 parallel groups.
Disease or disorder under study: Critical ischemia of the lower limbs in diabetic patients without the possibility of revascularization. Main valuation variable: Proportion of Adverse Events related to treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
90
Allogeneic mesenchymal stromal cells derived from adipose tissue administered intramuscularly
Allogeneic mesenchymal stromal cells derived from adipose tissue administered intramuscularly
0,9% physiological saline
Hospital General de Alicante
Alicante, Spain
Hospital Gregorio Marañon
Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
La Paz University Hospital
Madrid, Spain
Complication rate after treatment administration
Time frame: 1 year
Evaluation of vascularization though RMN
Time frame: 1 year
Rutherford-Becker scale
Time frame: 1 year
Wifi scale
Time frame: 1 year
Ankle arm index
Time frame: 1 year
Temperature
(ºC)
Time frame: 1 year
Twin perimeter
(cm)
Time frame: 1 year
Neuropathic symptoms (altered sensitivity)
Time frame: 1 year
% amputations
Time frame: 1 year
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Hospital Clinico Universitario Virgen de la Arrixaca
Murcia, Spain
Clinica Universidad de Navarra
Pamplona, Spain
Hospital Universitario de Salamanca
Salamanca, Spain
Hospital Victoria Eugenia Cruz Roja Española
Seville, Spain
Hospital Universitario La Fe
Valencia, Spain
Hospital de Valladolid
Valladolid, Spain