105
Participants
Start Date
March 8, 2025
Primary Completion Date
February 28, 2027
Study Completion Date
August 1, 2027
A - Allogenic ADSC cells in fibrin solution - two times administration ADSC/ASC
ADSC/ASC will be administered twice, at two-week intervals - during V0 and V2 visits The first dose will be administered one week after the randomisation visit. Control visits after administration will be performed every week, up to V6 visit (up to 6 weeks after V0).
B - Allogenic ADSC cells in fibrin solution - one time administration of ADSC/ASC, one time of placebo
ADSC/ASC will be administered once, at the time of the second application patients will receive a placebo - during V0 and V2 visits The first dose will be administered one week after the randomisation visit. Control visits after administration will be performed weekly, up to V6 visit (up to 6 weeks after V0)
C - Standard care in diabetic foot ulcer with aplication of fibrin gel to cover wound surface.
Placebo will be administered twice, at two-week intervals - during V0 and V2 visits The first dose will be administered one week after the randomisation visit. Control visits after administration will be performed every week, up to V6 visit (up to 6 weeks after V0).
Collaborators (1)
Medical Research Agency, Poland
OTHER_GOV
Medical University of Warsaw
OTHER