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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
August 18, 2011
August 19, 2011
August 22, 2011
February 9, 2012
February 9, 2012
January 2009
June 2011   (Final data collection date for primary outcome measure)
Mean Percent Reduction in Wound Surface Area [ Time Frame: baseline and 16 weeks ]
Mean % reduction in wound surface area [ Time Frame: 16 weeks ]
Complete list of historical versions of study NCT01420289 on ClinicalTrials.gov Archive Site
  • Percent Improvement in Peak Walking Time [ Time Frame: 16 weeks ]
    Percentage Improvement in the amount of time one can walk without pain
  • 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.

  • 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
  • Wound and Claudication Pain [ Time Frame: 16 weeks ]
  • Quality of life [ Time Frame: 16 weeks ]
    Using SF-36 QOL questionnaire
Not Provided
Not Provided
 
Effect of HPIPC for the Treatment of Ischemic Ulcers in Subjects With PAD
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
To evaluate the effects of HPIPC for the treatment of symptoms of PAD
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • PVD
  • Arterial Ulcers
  • Device: High pressure intermittent pneumatic compression (HPIPC)
    Apply therapy for 45 minutes twice daily
    Other Names:
    • Bio Arterial Plus
    • Art Assist
  • Behavioral: Excercise
    Treadmill walking 45 minutes once daily
    Other Name: Walking on a treadmill
  • Experimental: HPIPC
    High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 45 minutes twice daily
    Intervention: Device: High pressure intermittent pneumatic compression (HPIPC)
  • Active Comparator: Excercise
    Walking on a graded treadmill for 45 minutes once daily
    Intervention: Behavioral: Excercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
June 2011
June 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01420289
01-HPIPC-09
No
Not Provided
Not Provided
Oscar M. Alvarez, PhD, Calvary Hospital, Bronx, NY
Calvary Hospital, Bronx, NY
Not Provided
Principal Investigator: Oscar M Alvarez, PhD Director Wound Care Center
Calvary Hospital, Bronx, NY
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP