Botulinum Toxin A for Treatment of Catocholamine Induced Finger Necrosis

Study Overview
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Brief Summary
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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.

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

Conditions
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Catocholamine Induced Finger Necrosis

Intervention / Treatment
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* Drug: Botox
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment<br>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. | Drug: Botox<br>* 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.<br>|
| Placebo Comparator: Control<br>Injection of 0.5cc of normal saline (0.9% NaCl) to each injection site as in the Active drug arm. | Drug: Placebo<br>* Injection of 0.5cc of normal saline (0.9% NaCl) to each injection site as in the Active drug arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| index of Toe and Finger Ischemia (iTFI) | Score including: O2 peripheral saturation monitoring Bleeding Capillary refilling Limb temperature Limb discoloration | three months after drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amputation | Amputations performed - fingers, toe and limb - height and number of amputations | Three months after drug administration | 
| Patients survival | Survival | Three months after drug administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Botox, catocholamine, shock, vasomotor, Vasopressin, botulinum toxin