Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT01420289
Recruitment Status : Completed
First Posted : August 19, 2011
Results First Posted : February 9, 2012
Last Update Posted : February 9, 2012
Sponsor:
Information provided by (Responsible Party):
Oscar M. Alvarez, PhD, Calvary Hospital, Bronx, NY

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
To evaluate the effects of HPIPC for the treatment of symptoms of PAD

Condition or disease Intervention/treatment Phase
PVD Arterial Ulcers Device: High pressure intermittent pneumatic compression (HPIPC) Behavioral: Excercise Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Trial to Evaluate High Pressure Rapid Sequence, Intermittent Pneumatic Compression (HPIPC) for the Treatment of Intermittent Claudication, Pain and Ulcer Healing in Subjects With PAD
Study Start Date : January 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: HPIPC
High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 45 minutes twice daily
 Device: High pressure intermittent pneumatic compression (HPIPC)
Apply therapy for 45 minutes twice daily
Other Names:
  • Bio Arterial Plus
  • Art Assist
Active Comparator: Excercise
Walking on a graded treadmill for 45 minutes once daily
 Behavioral: Excercise
Treadmill walking 45 minutes once daily
Other Name: Walking on a treadmill


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Secondary Outcome Measures :
  1. Percent Improvement in Peak Walking Time [ Time Frame: 16 weeks ]
    Percentage Improvement in the amount of time one can walk without pain

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

    Percent improvement in SF-36 Quality of life (QOL) questionnaire score at baseline and at week-16.

    The higher the score on the SF-36 questionnaire the better the QOL.


  3. Wound Pain as Determined by a Visual Analog 10 Point Scale (VAS) for Pain. [ Time Frame: 16 weeks ]
    Percent change (improvement)in mean VAS pain scores at baseline and at 16 weeks


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Intermittent claudication >6mo
  • Ischemic ulceration or ulcer of mixed (venous) etiology
  • ABI < 0.7
  • Ambulatory
  • Able to comply

Exclusion Criteria:

  • Gangrene
  • M.I. within 6mo
  • Inability to walk
  • Wound infection
  • Systemic corticosteroids
  • HBO, Apligraf, Dermagraft within 6mo
  • Falsely elevated ankle to brachial index (ABI)
  • Inflammatory condition affecting healing
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01420289


Locations
Layout table for location information
United States, New York
Center for Curative and Palliative wound Care, Calvary Hospital
Bronx, New York, United States, 10461
Sponsors and Collaborators
Calvary Hospital, Bronx, NY
Investigators
Layout table for investigator information
Principal Investigator: Oscar M Alvarez, PhD Director Wound Care Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Oscar M. Alvarez, PhD, Director, Center for Curative andPalliative Wound Care, Calvary Hospital, Bronx, NY
ClinicalTrials.gov Identifier: NCT01420289    
Other Study ID Numbers: 01-HPIPC-09
First Posted: August 19, 2011    Key Record Dates
Results First Posted: February 9, 2012
Last Update Posted: February 9, 2012
Last Verified: August 2011
Keywords provided by Oscar M. Alvarez, PhD, Calvary Hospital, Bronx, NY:
Ischemic ulcers
PAD
Intermittent Claudication Pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Intermittent Claudication
Ulcer
Pathologic Processes
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases