Clinical Efficacy of Platelet Gel From Cord Blood for the Treatment of Diabetic Foot Ulcers

PHASE3CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

January 31, 2015

Primary Completion Date

February 28, 2017

Study Completion Date

February 28, 2017

Conditions
Diabetic Foot Ulcers
Interventions
BIOLOGICAL

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.

OTHER

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.

Trial Locations (9)

Unknown

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

08026

Hospital de la Santa Creu i Sant Pau - Servicio de Angiología, Cirugía Vascular y Endovascular, Barcelona

All Listed Sponsors
collaborator

Italian National Cord Blood Network

OTHER

lead

Centro Nazionale Sangue

OTHER_GOV

NCT02389010 - Clinical Efficacy of Platelet Gel From Cord Blood for the Treatment of Diabetic Foot Ulcers | Biotech Hunter | Biotech Hunter