Botulinum Toxin A for Treatment of Catocholamine Induced Finger Necrosis
Primary Purpose
Catocholamine Induced Finger Necrosis
Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Botox
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Catocholamine Induced Finger Necrosis focused on measuring Botox, catocholamine, shock, vasomotor, Vasopressin, botulinum toxin
Eligibility 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
Sites / Locations
- Sheba Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Treatment
Control
Arm Description
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 0.5cc of normal saline (0.9% NaCl) to each injection site as in the Active drug arm.
Outcomes
Primary Outcome Measures
index of Toe and Finger Ischemia (iTFI)
Score including:
O2 peripheral saturation monitoring Bleeding Capillary refilling Limb temperature Limb discoloration
Secondary Outcome Measures
Amputation
Amputations performed - fingers, toe and limb - height and number of amputations
Patients survival
Survival
Full Information
NCT ID
NCT01500668
First Posted
December 22, 2011
Last Updated
January 3, 2012
Sponsor
Sheba Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01500668
Brief Title
Botulinum Toxin A for Treatment of Catocholamine Induced Finger Necrosis
Official Title
Botulinum Toxin for Treatment of Catocholamine Induced Finger Necrosis - a Double Blind Randomized Control Prospective Study.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catocholamine Induced Finger Necrosis
Keywords
Botox, catocholamine, shock, vasomotor, Vasopressin, botulinum toxin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Injection of 0.5cc of normal saline (0.9% NaCl) to each injection site as in the Active drug arm.
Intervention Type
Drug
Intervention Name(s)
Botox
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Injection of 0.5cc of normal saline (0.9% NaCl) to each injection site as in the Active drug arm.
Primary Outcome Measure Information:
Title
index of Toe and Finger Ischemia (iTFI)
Description
Score including:
O2 peripheral saturation monitoring Bleeding Capillary refilling Limb temperature Limb discoloration
Time Frame
three months after drug administration
Secondary Outcome Measure Information:
Title
Amputation
Description
Amputations performed - fingers, toe and limb - height and number of amputations
Time Frame
Three months after drug administration
Title
Patients survival
Description
Survival
Time Frame
Three months after drug administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amir Herman, MD, PhD
Phone
972-52-2655026
Email
amirherm@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir Herman, MD, PhD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center
City
Tel-Hashomer
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amir Herman, MD, PhD
Phone
972-52-2655026
Email
amirherm@gmail.com
First Name & Middle Initial & Last Name & Degree
Amir Herman, MD, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
12771608
Citation
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.
Results Reference
background
PubMed Identifier
19258141
Citation
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.
Results Reference
background
PubMed Identifier
7359665
Citation
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.
Results Reference
background
PubMed Identifier
17255677
Citation
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.
Results Reference
background
PubMed Identifier
21855233
Citation
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.
Results Reference
background
PubMed Identifier
19116537
Citation
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.
Results Reference
background
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Botulinum Toxin A for Treatment of Catocholamine Induced Finger Necrosis
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