Evaluation of the safety and efficacy of an advanced therapy medicinal product containing live ASCs in the treatment of diabetic foot syndrome – a double-blind, randomized study.

DIABETIC FOOT ULCER

Change in wound surface area, Type, frequency, and severity of adverse events, Changes in laboratory tests and vital parameters Assessment time point: at the end of the active treatment phase (6 weeks after the first administration of ADSC/ASC)

Total percentage of patients with significant clinical success defined as achieving a specified degree of wound epithelialization: *Complete wound closure (100% epithelialization), or *Partial wound epithelialization (>50% epithelialization), Parameters for assessing clinical efficacy: *Change in wound surface area over time measured from the first administration of the treatment under investigation *Percentage of patients with significant clinical success over time assessed as complete wound closure (100% epithelialization), or partial wound epithelialization (>50% epithelialization), Dynamics of wound healing assessed as: *Time to achieve a 50% reduction in wound surface area *Time to achieve the greatest reduction in wound surface area *Time to achieve complete wound closure (100% epithelialization), Absolute change in pain perception over time assessed using the Visual Analogue Scale (VAS)., The need for antibiotic therapy due to wound infection *Number of patients *Number of antibiotic therapies *Assessment time points: at the end of the active treatment phase (6 weeks after the first administration of ADSC/ASC) and at the end of the study, Change in quality of life parameters according to the EQ-5D-5L questionnaire Assessment time points: at the end of the active treatment phase (6 weeks after the first administration of ADSC/ASC) and at the end of the study

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