The Efficacy and Safety of REX-001 to Treat Ischemic Ulcers in Subjects With CLI Rutherford Category 5 and DM

PHASE3TerminatedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

April 25, 2017

Primary Completion Date

February 13, 2023

Study Completion Date

February 13, 2023

Conditions
Peripheral Arterial Disease (PAD)Diabetes Mellitus (DM)Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2Cardiovascular DiseaseCritical Limb Ischemia (CLI)
Interventions
DRUG

REX-001

REX-001 is administered through an intra-arterial catheter.

DRUG

Placebo

Placebo is administered through an intra-arterial catheter.

Trial Locations (15)

Unknown

Fakultní nemocnice Ostrava, Ostrava

Pécsi Tudományegyetem, PTE-KK I. sz Belgyógyászati Klinika, Pécs

Leids Universitair Medisch Centrum, Leiden

Maastricht Universitair Medisch Centrum, Maastricht

Hospital Garcia de Orta, EPE, Almada

Centro Hospitalar Lisboa Norte, EPE, Lisbon

Centro Hospitalar de São João, Porto

Hospital Universitari Germans Trias i Pujol, Badalona

Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat

Hospital Universitari Vall d'Hebron, Barcelona

Hospital Universitario Puerta del Mar, Cadiz

First site: Hospital Universitario Reina Sofía, Córdoba

Hospital Regional Universitario, Málaga

Hospital General Universitario Morales Meseguer, Murcia

University Hospital of Wales, Cardiff

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Andalusian Network for Design and Translation of Advanced Therapies

OTHER

lead

Ixaka Ltd

INDUSTRY