Botulinum Toxin A for Treatment of Catocholamine Induced Finger Necrosis

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Catocholamine Induced Finger Necrosis	Drug: Botox; Drug: Placebo	Phase 4

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	20 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Botulinum Toxin for Treatment of Catocholamine Induced Finger Necrosis - a Double Blind Randomized Control Prospective Study.
Study Start Date :	January 2012
Estimated Primary Completion Date :	December 2013
Estimated Study Completion Date :	December 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Treatment; 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; 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.
Placebo Comparator: Control; Injection of 0.5cc of normal saline (0.9% NaCl) to each injection site as in the Active drug arm.	Drug: Placebo; Injection of 0.5cc of normal saline (0.9% NaCl) to each injection site as in the Active drug arm.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. index of Toe and Finger Ischemia (iTFI) [ Time Frame: three months after drug administration ]

   Score including:

   O2 peripheral saturation monitoring Bleeding Capillary refilling Limb temperature Limb discoloration

Secondary Outcome Measures :

1. Amputation [ Time Frame: Three months after drug administration ]
   Amputations performed - fingers, toe and limb - height and number of amputations
2. Patients survival [ Time Frame: Three months after drug administration ]
   Survival

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Amir Herman, MD, PhD	972-52-2655026	amirherm@gmail.com

Locations

Israel
Sheba Medical Center	Recruiting
Tel-Hashomer, Israel, 52621
Contact: Amir Herman, MD, PhD 972-52-2655026 amirherm@gmail.com
Principal Investigator: Amir Herman, MD, PhD

Sponsors and Collaborators

Sheba Medical Center

Investigators

Principal Investigator:	Amir Herman, MD, PhD	Sheba Medical Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Dünser MW, Mayr AJ, Tür A, Pajk W, Barbara F, Knotzer H, Ulmer H, Hasibeder WR. Ischemic skin lesions as a complication of continuous vasopressin infusion in catecholamine-resistant vasodilatory shock: incidence and risk factors. Crit Care Med. 2003 May;31(5):1394-8.

Fregene A, Ditmars D, Siddiqui A. Botulinum toxin type A: a treatment option for digital ischemia in patients with Raynaud's phenomenon. J Hand Surg Am. 2009 Mar;34(3):446-52. doi: 10.1016/j.jhsa.2008.11.026.

Golbranson FL, Lurie L, Vance RM, Vandell RF. Multiple extremity amputations in hypotensive patients treated with dopamine. JAMA. 1980 Mar 21;243(11):1145-6.

Van Beek AL, Lim PK, Gear AJ, Pritzker MR. Management of vasospastic disorders with botulinum toxin A. Plast Reconstr Surg. 2007 Jan;119(1):217-26.

Janz BA, Thomas PR, Fanua SP, Dunn RE, Wilgis EF, Means KR Jr. Prevention of anastomotic thrombosis by botulinum toxin B after acute injury in a rat model. J Hand Surg Am. 2011 Oct;36(10):1585-91. doi: 10.1016/j.jhsa.2011.07.008. Epub 2011 Aug 19.

Clemens MW, Higgins JP, Wilgis EF. Prevention of anastomotic thrombosis by botulinum toxin a in an animal model. Plast Reconstr Surg. 2009 Jan;123(1):64-70. doi: 10.1097/PRS.0b013e3181904c31.

Responsible Party:	Dr. Amir Herman, Principal Investigator, Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT01500668 History of Changes
Other Study ID Numbers:	SHEBA-11-9023-AH-CTIL; 9023-11-SMC ( Other Grant/Funding Number: Sheba medical center )
First Posted:	December 28, 2011
Last Update Posted:	January 5, 2012
Last Verified:	January 2012

Keywords provided by Dr. Amir Herman, Sheba Medical Center:

Botox; catocholamine; shock	vasomotor; Vasopressin; botulinum toxin

Additional relevant MeSH terms:

Necrosis; Pathologic Processes; Botulinum Toxins; onabotulinumtoxinA; Botulinum Toxins, Type A; abobotulinumtoxinA; Acetylcholine Release Inhibitors	Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Neuromuscular Agents; Peripheral Nervous System Agents