The objective of this proof-of-concept study is to test in no-option CLI patients whether ARA 290 (a) reduces limb pain, (b) reduces signs of local and systemic inflammation, and (c) promotes wound healing.
ID
Bron
Aandoening
Critical limb ischemia
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Safety and tolerability parameters;<br>
2. General safety measurements;<br>
3. 12-lead ECG (only base line and visits on day 5 and 26);<br>
4. Hematology;<br>
5. Blood Biochemistry;<br>
6. Adverse Event monitoring;<br>
7. Pain Scores (VAS + Brief Pain Inventory);<br>
8. Allodynia and Hyperalgesia Testing;<br>
9. Autonomic nervous system measurement (only baseline and day 5);<br>
10. Analgesics use (diary);<br>
11. Wound healing (calibrated photos);<br>
12. Circulating inflammatory markers;<br>
13. Insulin sensitivity (fasting HOMA);<br>
14. Quality of life (RAND-36) (only base line and day 26).
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
The objective of this proof-of-concept study is to test in no-option CLI patients whether ARA 290 (a) reduces limb pain, (b) reduces signs of local and systemic inflammation, and (c) promotes wound healing.
Onderzoeksopzet
Day 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26.
Onderzoeksproduct en/of interventie
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-exchange chromatography, and stored as a lyophilized powder. ARA-290 will be administered 3 times a week for 4 weeks.
Algemeen / deelnemers
Dept. Vascular Surgery
P.O.Box 9600
Jan H.N. Lindeman
Leiden 2300 RC
The Netherlands
+31 (0)71 5263968
Lindeman@LUMC.nl
Wetenschappers
Dept. Vascular Surgery
P.O.Box 9600
Jan H.N. Lindeman
Leiden 2300 RC
The Netherlands
+31 (0)71 5263968
Lindeman@LUMC.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Critical limb ischemia;
2. No option for conventional revascularization;
3. Written informed consent;
4. Expected life expectancy > 1 year.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2294 |
| NTR-old | NTR2685 |
| Ander register | METC LUMC / ABR : P10.85 / NL31947.058.10 ; |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |