Botulinum Toxin A for Treatment of Catocholamine Induced Finger Necrosis

Phase 4

• Conditions: Catocholamine Induced Finger Necrosis
• Interventions: Drug: Placebo; Drug: Botox

• Registration Number: NCT01500668
• Lead Sponsor: Sheba Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-22
• Study First Submitted QC: 2011-12-27
• Study First Posted: 2011-12-28
• Status Verified: 2012-01
• Study Start: 2012-01
• Last Update Submitted: 2012-01-03
• Last Update Posted: 2012-01-05
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	Injection of 0.5cc of normal saline (0.9% NaCl) to each injection site as in the Active drug arm.
Treatment	Botox	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.

Primary Outcome Measures

Name	Time	Method
index of Toe and Finger Ischemia (iTFI)	three months after drug administration	Score including: O2 peripheral saturation monitoring Bleeding Capillary refilling Limb temperature Limb discoloration

Secondary Outcome Measures

Name	Time	Method
Amputation	Three months after drug administration	Amputations performed - fingers, toe and limb - height and number of amputations
Patients survival	Three months after drug administration	Survival

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Tel-Hashomer, Israel