A phase II study of ARA290 as therapeutic strategy in no-option critical limb ischemia patients.

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 8

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>•General safety measurements<br>•12-lead ECG (only base line and visit day 26)<br>•Haematology<br>•Blood Biochemistry<br>•Adverse Event monitoring<br>Efficacy Parameters:<br>•Pain Scores (VAS + Brief Pain Inventory)<br>•Analgesics use (diary)<br>•Wound healing (calibrated photos)<br>•Circulating inflammatory markers <br>•Insulin sensitivity (fasting HOMA)<br>•Quality of life (RAND-36) (only base line and day 26)<br>

Secondary Outcome Measures

Name	Time	Method

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