A phase II study of ARA 290 as therapeutic strategy in no-option critical limb ischemia patients.

Phase 2

Withdrawn

• Conditions: Critical limb ischemia; 10040795; 10003216

• Registration Number: NL-OMON34878
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

Critical limb ischemia
No option for conventional revascularization
Written informed consent
Expected life expectancy > 1 year

Exclusion Criteria

Overt diabetic disease
Clinically relevant abnormal history of physical and mental health other than conditions related to CLI, as determined by medical history taking (as judged by the investigator);
Clinically relevant abnormal laboratory results, ECG, vital signs, or physical findings other than conditions related to CLI (as judged by the investigator)
Subject has a history of severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
Participation in an investigational drug trial in the 3 months prior to administration of the initial dose of study drug or more than 4 times per year
Use of erythropoietin, systemic corticosteroids (e.g. prednisone etc.) and other immune modulatory drugs

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Wond healing<br /><br>Pedal pain<br /><br>Local inflammation</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Systemic inflammation<br /><br>Safety</p><br>