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Botox for Catecholamine Induced Finger Necrosis
NCT01500668Phase 4
Key facts
- Status
- Unknown
- Start
- Jan 2012
- Primary completion
- Dec 2013
- Countries
- 1
- Sponsor
- Sheba Medical Center
- Modality
- Recombinant Proteins and Enzymes
- Conditions
- digital ischemia
01
Overview
Phase 4, randomised, double-blind trial in digital ischemia comparing Botox Arm with Placebo Arm (2 arms). Primary endpoint: index of Toe and Finger Ischemia at 3 months. Status: unknown.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Botox Arm
Injection of 200 units of Botulinum Toxin A
Placebo Arm
Injection of normal saline
03
Who it enrols
Adult ICU patients treated with vasoactive drugs (amines) who have finger/toe necrosis, excluding those with active local limb infection, botulism, or chronic muscular weakness diseases like Myasthenia gravis or ALS.
04
Endpoints
Primary
index of Toe and Finger Ischemia
Secondary
Amputation
Patients survival
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