Clinical Trials Directory

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UnknownNCT01500668

Botulinum Toxin A for Treatment of Catocholamine Induced Finger Necrosis

Botulinum Toxin for Treatment of Catocholamine Induced Finger Necrosis - a Double Blind Randomized Control Prospective Study.

Status
Unknown
Phase
Phase 4
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
Sheba Medical Center · Other Government
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Patients in the intensive care unit (ICU) often require blood pressure support of vasoactive drugs such as amines. Finger necrosis (so called "blue toe syndrome") is a well documented phenomena with incidence reaching as high as 60% in patients receiving vasopressin. Botulinum toxin is a known muscle relaxant used for a variety of medical application. Recently, several reports have demonstrated its effect in vasospastic disorders. It has also been in mice that when administered locally it has a local vasodilatory effect. The goal of this experiment is to compare the effect of Botulinum Toxin administered locally on amine induced finger necrosis.

Conditions

Interventions

TypeNameDescription
DRUGBotoxInjection of 200 units of Botulinum Toxin A (BOTOX) to a treated limb. Each limb will be divided to two levels - arterial arch and digital arteries (near MCP/MTP) levels. In each level 100 units of Botox will be injected in 6 injection points in the proximity of the arteries.
DRUGPlaceboInjection of 0.5cc of normal saline (0.9% NaCl) to each injection site as in the Active drug arm.

Timeline

Start date
2012-01-01
Primary completion
2013-12-01
Completion
2013-12-01
First posted
2011-12-28
Last updated
2012-01-05

Locations

1 site across 1 country: Israel

Source: ClinicalTrials.gov record NCT01500668. Inclusion in this directory is not an endorsement.