Botulinum Toxin A for Treatment of Catocholamine Induced Finger Necrosis
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| ClinicalTrials.gov Identifier: NCT01500668 |
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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
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Sponsor:
Sheba Medical Center
Information provided by (Responsible Party):
Dr. Amir Herman, Sheba Medical Center
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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 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 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
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Placebo Comparator: Control
Injection of 0.5cc of normal saline (0.9% NaCl) to each injection site as in the Active drug arm.
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Drug: Placebo
Injection of 0.5cc of normal saline (0.9% NaCl) to each injection site as in the Active drug arm. |
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
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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
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
| 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 |
Publications:
| 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:
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Botox catocholamine shock |
vasomotor Vasopressin botulinum toxin |
Additional relevant MeSH terms:
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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 |