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

NCT03174522 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2023-03-16

No results posted yet for this study

Summary

This trial is a pivotal, placebo-controlled, double-blind, parallel-group, adaptive trial conducted in subjects with DM and CLI Rutherford Category 5. Minimisation will be used to assign eligible subjects in a 2:1 ratio to receive a single intra-arterial administration of REX-001 or matching placebo into the index limb.

Conditions

  • Peripheral Arterial Disease (PAD)
  • Diabetes Mellitus (DM)
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
  • Cardiovascular Disease
  • Critical 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.

Sponsors & Collaborators

  • Andalusian Network for Design and Translation of Advanced Therapies

    collaborator OTHER

  • Ixaka Ltd

    lead INDUSTRY

Principal Investigators

  • Gilbert Wagener, MD · Ixaka Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-25
Primary Completion
2023-02-13
Completion
2023-02-13

Countries

  • Czechia
  • Hungary
  • Netherlands
  • Portugal
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03174522 on ClinicalTrials.gov