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

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.

Timeline

Start

2017-04-25

Primary completion

2023-02-13

Completion

2023-02-13

Outcome

Outcome not reported

Stopped: “Independent Data Monitoring Committee recommendation to stop due to futility”

Drugs

Indications