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

Suspended

• Conditions: Critical limb ischemia

• Registration Number: NL-OMON28106
• Lead Sponsor: MC

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

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

Inclusion Criteria

1. Critical limb ischemia;

2. No option for conventional revascularization;

Exclusion Criteria

1. Poorly regulated diabetic disease (HbA1c >10%);

2. 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);

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Safety and tolerability parameters;<br /><br>2. General safety measurements;<br /><br>3. 12-lead ECG (only base line and visits on day 5 and 26);<br /><br>4. Hematology;<br /><br>5. Blood Biochemistry;<br /><br>6. Adverse Event monitoring;<br /><br>7. Pain Scores (VAS + Brief Pain Inventory);<br /><br>8. Allodynia and Hyperalgesia Testing;<br /><br>9. Autonomic nervous system measurement (only baseline and day 5);<br /><br>10. Analgesics use (diary);<br /><br>11. Wound healing (calibrated photos);<br /><br>12. Circulating inflammatory markers;<br /><br>13. Insulin sensitivity (fasting HOMA);<br /><br>14. Quality of life (RAND-36) (only base line and day 26).