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Effect of HPIPC for the Treatment of Ischemic Ulcers in Subjects With PAD

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01420289
First Posted: August 19, 2011
Last Update Posted: February 9, 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.
Information provided by (Responsible Party):
Oscar M. Alvarez, PhD, Calvary Hospital, Bronx, NY
Results First Submitted: August 22, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: PVD
Arterial Ulcers
Interventions: Device: High pressure intermittent pneumatic compression (HPIPC)
Behavioral: Excercise

  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
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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
HPIPC High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
Excercise Walking on a graded treadmill for 45 minutes once daily

Participant Flow:   Overall Study
    HPIPC   Excercise
STARTED   18   16 
COMPLETED   18   16 
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.
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Reporting Groups
  Description
HPIPC High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
Excercise Walking on a graded treadmill for 45 minutes once daily
Total Total of all reporting groups

Baseline Measures
   HPIPC   Excercise   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   16   34 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   14   14   28 
>=65 years   4   2   6 
Age 
[Units: Years]
Mean (Standard Deviation)
 64  (12)   62  (11)   63  (12) 
Gender 
[Units: Participants]
     
Female   6   6   12 
Male   12   10   22 
Region of Enrollment 
[Units: Participants]
     
United States   18   16   34 


  Outcome Measures
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1.  Primary:   Mean Percent Reduction in Wound Surface Area   [ Time Frame: baseline and 16 weeks ]

2.  Secondary:   Percent Improvement in Peak Walking Time   [ Time Frame: 16 weeks ]

3.  Secondary:   Perceived Improvement in Physical Function After 16 Weeks   [ Time Frame: 16 weeks ]

4.  Secondary:   Wound Pain as Determined by a Visual Analog 10 Point Scale (VAS) for Pain.   [ Time Frame: 16 weeks ]


  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 PhD, Director Center for Curative and Palliative Wound Care
Organization: Calvary Hospital
phone: 718-518-2577
e-mail: oalvarez@calvaryhospital.org



Responsible Party: Oscar M. Alvarez, PhD, Calvary Hospital, Bronx, NY
ClinicalTrials.gov Identifier: NCT01420289     History of Changes
Other Study ID Numbers: 01-HPIPC-09
First Submitted: August 18, 2011
First Posted: August 19, 2011
Results First Submitted: August 22, 2011
Results First Posted: February 9, 2012
Last Update Posted: February 9, 2012