Botulinum Toxin A for Treatment of Catocholamine Induced Finger Necrosis

Sheba Medical Center

Status and phase: Unknown; Phase 4

Conditions: Catocholamine Induced Finger Necrosis

Treatments: Drug: Placebo; Drug: Botox

Study type: Interventional

Funder types: Other

Identifiers

NCT01500668

SHEBA-11-9023-AH-CTIL

9023-11-SMC (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients treated with vasoactive drugs (amines) and have finger/toe necrosis

Exclusion criteria

• Sensitivity to drug (Botox) ingredients.
• Active local limb infection
• ICU admission due to botulism
• Chronic muscular weakness disease, e.g., Myasthenia gravis, ALS
• Age lower than 18

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

Treatment

Active Comparator group

Description:

Injection 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.

Treatment:

Drug: Botox

Control

Placebo Comparator group

Description:

Injection of 0.5cc of normal saline (0.9% NaCl) to each injection site as in the Active drug arm.

Treatment:

Drug: Placebo