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

> **NCT03174522** · PHASE3 · TERMINATED · sponsor: **Ixaka Ltd** · enrollment: 49 (actual)

## Conditions studied

- 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
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT03174522
- **Lead sponsor:** Ixaka Ltd
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2017-04-25
- **Primary completion:** 2023-02-13
- **Final completion:** 2023-02-13
- **Target enrollment:** 49 (ACTUAL)
- **Why stopped:** Independent Data Monitoring Committee recommendation to stop due to futility
- **Last updated:** 2023-03-16

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03174522

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03174522, "The Efficacy and Safety of REX-001 to Treat Ischemic Ulcers in Subjects With CLI Rutherford Category 5 and DM". Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/clinical/NCT03174522. Licensed CC0.

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