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
  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:


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
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:
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, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014