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

This study has been completed.
Sponsor:
Collaborators:
RTS Family Foundation
New York State Department of Health
Information provided by:
Calvary Hospital, Bronx, NY
ClinicalTrials.gov Identifier:
NCT01079299
First received: March 2, 2010
Last updated: January 9, 2012
Last verified: August 2010
Results First Received: August 18, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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
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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  
Number of Participants  
[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
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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: Oscar M. Alvarez / Principal Investigator
Organization: Center for Curative and Palliative Wound Care Calvary Hospital
phone: 718-518-2577
e-mail: oalvarez@calvaryhospital.org


No publications provided


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
Study First Received: March 2, 2010
Results First Received: August 18, 2011
Last Updated: January 9, 2012
Health Authority: United States: Institutional Review Board