- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01500668
Botulinum Toxin A for Treatment of Catocholamine Induced Finger Necrosis
January 3, 2012 updated by: Dr. Amir Herman, Sheba Medical Center
Botulinum Toxin for Treatment of Catocholamine Induced Finger Necrosis - a Double Blind Randomized Control Prospective Study.
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Amir Herman, MD, PhD
- Phone Number: 972-52-2655026
- Email: amirherm@gmail.com
Study Locations
-
-
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Tel-Hashomer, Israel, 52621
- Recruiting
- Sheba Medical Center
-
Contact:
- Amir Herman, MD, PhD
- Phone Number: 972-52-2655026
- Email: amirherm@gmail.com
-
Principal Investigator:
- Amir Herman, MD, PhD
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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.
|
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.
|
Injection of 0.5cc of normal saline (0.9% NaCl) to each injection site as in the Active drug arm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
three months after drug administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amputation
Time Frame: Three months after drug administration
|
Amputations performed - fingers, toe and limb - height and number of amputations
|
Three months after drug administration
|
Patients survival
Time Frame: Three months after drug administration
|
Survival
|
Three months after drug administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amir Herman, MD, PhD, Sheba Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Van Beek AL, Lim PK, Gear AJL, Pritzker MR. Management of vasospastic disorders with botulinum toxin A. Plast Reconstr Surg. 2007 Jan;119(1):217-226. doi: 10.1097/01.prs.0000244860.00674.57.
- 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.
- Dunser MW, Mayr AJ, Tur 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. doi: 10.1097/01.CCM.0000059722.94182.79.
- 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.
- 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 EFS. 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Anticipated)
December 1, 2013
Study Completion (Anticipated)
December 1, 2013
Study Registration Dates
First Submitted
December 22, 2011
First Submitted That Met QC Criteria
December 27, 2011
First Posted (Estimate)
December 28, 2011
Study Record Updates
Last Update Posted (Estimate)
January 5, 2012
Last Update Submitted That Met QC Criteria
January 3, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHEBA-11-9023-AH-CTIL
- 9023-11-SMC (Other Grant/Funding Number: Sheba medical center)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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