NCT03174522

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

The Efficacy and Safety of Intra-arterial Administration of REX-001 to Treat Ischemic Ulcers in Subjects With Critical Limb Ischemia (CLI) Rutherford Category 5 and Diabetes Mellitus: A Pivotal, Placebo-controlled, Double-blind, Parallel-group, Adaptive Trial

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Ixaka Ltd · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	REX-001	REX-001 is administered through an intra-arterial catheter.
DRUG	Placebo	Placebo is administered through an intra-arterial catheter.

Timeline

• Start date: 2017-04-25
• Primary completion: 2023-02-13
• Completion: 2023-02-13
• First posted: 2017-06-02
• Last updated: 2023-03-16

Locations

15 sites across 6 countries: Czechia, Hungary, Netherlands, Portugal, Spain, United Kingdom