SYFf919c50a0af646f18e80f73999f229e4Registry ID: 2024-519687-40-00|RecruitingPhase 2/3
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interventional
N/A
1 country
1
The aim of the project is to compare the effect on tissue oxygenation and clinical outcome of autologous cell therapy with standard treatment in patients with chronic limb-threatening ischemia (CLTI) and diabetic foot ulcers (DFU) not eligible for PTA and to verify the effect of repetitive cell therapy.
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November 28, 2024
Actual (reported)Comparison of cell therapy with standard treatment in several parameters: Assessment of tissue oxygenation – improvement of parameters of ischemia (measured by transcutaneous oxygen pressure andoptionally by other angiological methods)
Comparison of cell therapy with standard treatment in several parameters: Clinical effect – wound healing, change in pain, rate of major amputation, amputation-free survival
Safety: adverse events - expected and unexpected
Assesment of study treatment by patients (psychological questionaries)
To assess the relation between the quality of cell suspension and tissue oxygenation
Institute For Clinical And Experimental Medicine
Prague, 140 00, Czechia
Michal Dubský
First Submitted
November 28, 2024
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