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Platelet Lysate for Therapeutic Angiogenesis in PAD
NCT02941419Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2013
- Primary completion
- Sep 2016
- Sponsor
- University of Jordan
- Modality
- Blood Coagulation Factors
- Drugs
- platelet lysate
- Conditions
- critical limb ischemia (CLI)
01
Overview
Phase 2, open-label, single-arm trial of platelet lysate in critical limb ischemia (CLI), sponsored by University of Jordan. Primary endpoint: Assessment the safety of platelet lysate injection at 6 months. Started Mar 2013; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Platelet lysate injection
Injection of platelet lysate intramuscularly in the gastrocnemius muscle
03
Who it enrols
Patients with established PAD (Rutherford 3, 4), history of intermittent claudication > 8 weeks, and not eligible for surgical revascularization.
04
Endpoints
Primary
Assessment the safety of platelet lysate injection
Secondary
Assessment the efficacy of platelet lysate injection
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