Botulinum Toxin A for Treatment of Catocholamine Induced Finger Necrosis

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ClinicalTrials.gov Identifier: NCT01500668

Recruitment Status : Unknown

Verified January 2012 by Dr. Amir Herman, Sheba Medical Center.
Recruitment status was: Recruiting

First Posted : December 28, 2011

Last Update Posted : January 5, 2012

Sponsor:

Information provided by (Responsible Party):

Dr. Amir Herman, Sheba Medical Center

Study Description

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Drug Information available for: OnabotulinumtoxinA Abobotulinumtoxina

U.S. FDA Resources

Arms and Interventions

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

Primary Outcome Measures :

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 :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01500668

Contacts

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

Locations

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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

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

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.

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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 Key Record Dates
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:

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Necrosis Pathologic Processes Botulinum Toxins 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

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