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Effect of Intermittent Pneumatic Compression on Ulcer Healing in Subjects With Secondary Lymphedema

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01079299
First Posted: March 3, 2010
Last Update Posted: February 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
RTS Family Foundation
New York State Department of Health
Information provided by:
Calvary Hospital, Bronx, NY
Results First Submitted: August 18, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Lymphedema
Intervention: Device: Intermittent, gradient, pneumatic compression device

  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
52 subjects were treated, IPC n=27, Control n=25

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
IPC Plus Standard Compression No text entered.
Standard Compression Alone No text entered.

Participant Flow:   Overall Study
    IPC Plus Standard Compression   Standard Compression Alone
STARTED   27   25 
COMPLETED   27   25 
NOT COMPLETED   0   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
IPC Plus Standard Compression No text entered.
Standard Compression Alone No text entered.
Total Total of all reporting groups

Baseline Measures
   IPC Plus Standard Compression   Standard Compression Alone   Total 
Overall Participants Analyzed 
[Units: Participants]
 27   25   52 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   11   13   24 
>=65 years   16   12   28 
Age 
[Units: Years]
Mean (Standard Deviation)
 66  (5.6)   59  (4.9)   62  (5) 
Gender 
[Units: Participants]
     
Female   10   9   19 
Male   17   16   33 
Region of Enrollment 
[Units: Participants]
     
United States   27   25   52 


  Outcome Measures

1.  Primary:   Median Time to Wound Closure at 9 Months   [ Time Frame: 9 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
No text entered.


  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: Oscar M. Alvarez / Principal Investigator
Organization: Center for Curative and Palliative Wound Care Calvary Hospital
phone: 718-518-2577
e-mail: oalvarez@calvaryhospital.org



Responsible Party: Oscar M. Alvarez, PhD / Principal Investigator, Center for curative and Palliative Wound Care, Calvary Hospital
ClinicalTrials.gov Identifier: NCT01079299     History of Changes
Other Study ID Numbers: CL-VU-0308
First Submitted: March 2, 2010
First Posted: March 3, 2010
Results First Submitted: August 18, 2011
Results First Posted: February 10, 2012
Last Update Posted: February 10, 2012



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