Critical limb ischemia
Conditions
Interventions
ARA 290 is an 11-amino acid, linear peptide that is being developed as a tissue protective peptide. ARA 290 is manufactured by standard F-moc solid phase peptide synthesis, purified by HPLC and ion-ex
Sponsors
LUMC
Eligibility
Inclusion criteria
Inclusion criteria: 1. Critical limb ischemia; 2. No option for conventional revascularization; 3. Written informed consent; 4. Expected life expectancy > 1 year.
Exclusion criteria
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); 3. Clinically relevant abnormal laboratory results, ECG, vital signs, or physical findings other than conditions related to CLI (as judged by the investigator); 4. Subject has a history of severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food; 5. 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; 6. Use of erythropoietin, systemic corticosteroids (e.g. prednisone etc.) and other immune modulatory drugs; 7. Inability to follow the protocol and to comply with the follow up requirements; 8. Any other condition that in the opinion of the investigator would complicate or compromise the study, or the well being of the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety and tolerability parameters; 2. General safety measurements; 3. 12-lead ECG (only base line and visits on day 5 and 26); 4. Hematology; 5. Blood Biochemistry; 6. Adverse Event monitoring; 7. Pain Scores (VAS + Brief Pain Inventory); 8. Allodynia and Hyperalgesia Testing; 9. Autonomic nervous system measurement (only baseline and day 5); 10. Analgesics use (diary); 11. Wound healing (calibrated photos); 12. Circulating inflammatory markers; 13. Insulin sensitivity (fasting HOMA); 14. Quality of life (RAND-36) (only base line and day 26). | — |
Contacts
Public ContactJan H.N. Lindeman
Leiden University Medical Center Dept. Vascular Surgery P.O.Box 9600
Outcome results
None listed