50
Participants
Start Date
January 31, 2015
Primary Completion Date
February 28, 2017
Study Completion Date
February 28, 2017
Allogeneic cord blood platelet gel-CBPG
For the medication of patients, one CBPG unit (mean volume 10 mL, range 5-15; mean platelet concentration 1 x 109/L, range 0.8 - 1.2 x 109/L. 10 mL in plasma) will be administered every 3-4 days. CBPG units, cryopreserved and stored in a plastic bag in a -80°C freezer, will be thawed at 37°C in a waterbath and activated with Calcium gluconate and immediately transported to sites of clinical use and applied to the skin ulcer without breaking the sterility chain.
Standard Local Medications-SLM
Each clinical center will use their validated standard local medications. Details and specifications of the local standard medication procedures will be collected from each participating centre.
Ospedaliero-Universitaria di Bologna, Bologna
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan
"Presidio Ospedaliero Spirito Santo", Pescara
Azienda Ospedalero-Universitaria Pisana, Pisa
"Presidio Ospedaliero E. Morelli", Reggio Calabria
"Policlinico Umberto I - Sapienza Università di Roma", Roma
Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo
A.O.U. Citta della Salute e della Scienza di Torino, Torino
Hospital de la Santa Creu i Sant Pau - Servicio de Angiología, Cirugía Vascular y Endovascular, Barcelona
Italian National Cord Blood Network
OTHER
Centro Nazionale Sangue
OTHER_GOV