Safety Study of Transvenous Limb Perfusion in Human Muscular Dystrophy

This study has been completed.
Sponsor:
Collaborators:
University of North Carolina
Information provided by (Responsible Party):
William Powers, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00873782
First received: April 1, 2009
Last updated: February 27, 2015
Last verified: January 2015
Results First Received: January 22, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Muscular Dystrophies
Duchenne Muscular Dystrophy
Becker Muscular Dystrophy
Limb-Girdle Muscular Dystrophy
Intervention: Other: Retrograde high pressure transvenous perfusion with normal saline

  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
High Pressure Transvenous Limb Perfusion Participants will undergo retrograde high pressure transvenous limb perfusion of an arm or a leg with normal saline through an 18g or 20g peripheral catheter with a tourniquet on the upper part of the limb: The volume of saline as % of perfused limb volume was escalated beginning at 5%. Safety was determined by Doppler ultrasound to assess venous and arterial damage electrodiagnostic neurographic testing quantitative muscle testing strength assessments, the Action Research Arm Test (ARAT), basic metabolic panel (Na+, K+, Cl-, CO2, BUN, and creatinine), serum creatine kinase [CK], plasma and urine myoglobin. Some subjects underwent MRI to assess whether saline went subcutaneously or intramuscularly.

Participant Flow:   Overall Study
    High Pressure Transvenous Limb Perfusion  
STARTED     16  
COMPLETED     16  
NOT COMPLETED     0  



  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
High Pressure Transvenous Limb Perfusion Participants will undergo retrograde high pressure transvenous limb perfusion of an arm or a leg with normal saline through an 18g or 20g peripheral catheter with a tourniquet on the upper part of the limb: The volume of saline as % of perfused limb volume was escalated beginning at 5%. Safety was determined by Doppler ultrasound to assess venous and arterial damage electrodiagnostic neurographic testing quantitative muscle testing strength assessments, the Action Research Arm Test (ARAT), basic metabolic panel (Na+, K+, Cl-, CO2, BUN, and creatinine), serum creatine kinase [CK], plasma and urine myoglobin. Some subjects underwent MRI to assess whether saline went subcutaneously or intramuscularly.

Baseline Measures
    High Pressure Transvenous Limb Perfusion  
Number of Participants  
[units: participants]
  16  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     16  
>=65 years     0  
Age  
[units: years]
Mean (Standard Deviation)
  31  (8)  
Gender  
[units: participants]
 
Female     7  
Male     9  
Region of Enrollment  
[units: participants]
 
United States     16  



  Outcome Measures

1.  Primary:   Muscle, Nerve, or Vascular Damage   [ Time Frame: Measured within 2 weeks after limb perfusion procedure ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: William J. Powers, MD
Organization: University of North Carolina at Chapel HIll
phone: 919 966 8178
e-mail: powersw@neurology.unc.edu


No publications provided


Responsible Party: William Powers, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00873782     History of Changes
Other Study ID Numbers: U54 AR056953, U54AR056953
Study First Received: April 1, 2009
Results First Received: January 22, 2015
Last Updated: February 27, 2015
Health Authority: United States: Federal Government