Botulinum Toxin A for Treatment of Catocholamine Induced Finger Necrosis

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2012 by Sheba Medical Center.
Recruitment status was Recruiting

Sponsor:

Information provided by (Responsible Party):

Dr. Amir Herman, Sheba Medical Center

ClinicalTrials.gov Identifier:

NCT01500668

First received: December 22, 2011

Last updated: January 3, 2012

Last verified: January 2012

History of Changes

Purpose

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	Intervention	Phase
Catocholamine Induced Finger Necrosis	Drug: Botox Drug: Placebo	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Botulinum Toxin for Treatment of Catocholamine Induced Finger Necrosis - a Double Blind Randomized Control Prospective Study.

Resource links provided by NLM:

MedlinePlus related topics: Botox

Drug Information available for: OnabotulinumtoxinA

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:

index of Toe and Finger Ischemia (iTFI) [ Time Frame: three months after drug administration ] [ Designated as safety issue: No ]
Score including:

O2 peripheral saturation monitoring Bleeding Capillary refilling Limb temperature Limb discoloration

Secondary Outcome Measures:

Amputation [ Time Frame: Three months after drug administration ] [ Designated as safety issue: No ]
Amputations performed - fingers, toe and limb - height and number of amputations
Patients survival [ Time Frame: Three months after drug administration ] [ Designated as safety issue: Yes ]
Survival


Estimated Enrollment:	20
Study Start Date:	January 2012
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01500668

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

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
Study First Received:	December 22, 2011
Last Updated:	January 3, 2012
Health Authority:	Israel: Ethics Commission

Keywords provided by Sheba Medical Center:


Botox catocholamine shock	vasomotor Vasopressin botulinum toxin

Additional relevant MeSH terms:


Necrosis Pathologic Processes Botulinum Toxins Anti-Dyskinesia Agents	Central Nervous System Agents Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015

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