Critical Limb Ischemia MedDRA version: 12.1 Level: LLT Classification code 10058069 Term: Critical limb ischemia
Conditions
Sponsors
LUMC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Critical limb ischemia No option for conventional revascularization Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Overt diabetic disease Clinically relevant abnormal history of physical and mental health other than conditions related to chronic kidney disease of patient, 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 chronic kidney disease of patient (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 Inability to follow the protocol and to comply with the follow up requirements 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 |
|---|---|
| Main Objective: To test whether ARA-290 (1) reduces limb pain, (2) reduces signs of local and systemic inflammation (3) promotes wound healing ;Secondary Objective: Tolerability of ARA-290;Primary end point(s): Safety and tolerability parameters: • General safety measurements • 12-lead ECG (only base line and visit day 26) • Haematology • Blood Biochemistry • Adverse Event monitoring Efficacy Parameters: • Pain Scores (VAS + Brief Pain Inventory) • Analgesics use (diary) • Wound healing (calibrated photos) • Circulating inflammatory markers • Insulin sensitivity (fasting HOMA) • Quality of life (RAND-36) (only base line and day 26) | — |
Countries
Netherlands
Outcome results
None listed