Treatment of Vasopressor-induced Ischemia With Botulinum Toxin A

This study has been terminated.
(Low accrual)
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01483209
First received: November 29, 2011
Last updated: February 16, 2015
Last verified: February 2015
Results First Received: February 16, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Ischemia
Vasopressor
Intervention: Drug: Injection of botulinum toxin A

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Boxtox Injection Subjects will serve as their own controls. Both hands are evaluated and the hand demonstrating more severe ischemia will be the one to receive the Botox (experimental treatment).

Participant Flow:   Overall Study
    Boxtox Injection  
STARTED     2  
COMPLETED     1  
NOT COMPLETED     1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Boxtox Injection Subjects will serve as their own controls. Both hands are evaluated and the hand demonstrating more severe ischemia will be the one to receive the Botox (experimental treatment).

Baseline Measures
    Boxtox Injection  
Number of Participants  
[units: participants]
  2  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     0  
>=65 years     2  
Gender  
[units: participants]
 
Female     2  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     2  



  Outcome Measures
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1.  Primary:   Perfusion (as Determined by Laser Doppler Measurements)   [ Time Frame: 12 months ]

2.  Secondary:   Digital Amputations   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Due to low accrual for this study we were unable to perform any data analysis.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Cynthia Shortell
Organization: Duke University Medical Center
phone: 919-681-2223
e-mail: cynthia.shortell@duke.edu



Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01483209     History of Changes
Other Study ID Numbers: Pro00032002
Study First Received: November 29, 2011
Results First Received: February 16, 2015
Last Updated: February 16, 2015
Health Authority: United States: Institutional Review Board