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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
  Purpose
To evaluate the effects of HPIPC for the treatment of symptoms of PAD

Condition Intervention
PVD Arterial Ulcers Device: High pressure intermittent pneumatic compression (HPIPC) Behavioral: Excercise

Study Type: Interventional
Study Design: 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

Further study details as provided by Oscar M. Alvarez, PhD, Calvary Hospital, Bronx, NY:

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

Secondary Outcome Measures:
  • 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


Enrollment: 44
Study Start Date: January 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
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
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
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
Principal Investigator: Oscar M Alvarez, PhD Director Wound Care Center
  More Information

Responsible Party: Oscar M. Alvarez, PhD, Director, Center for Curative andPalliative Wound Care, 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
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:
Ulcer
Intermittent Claudication
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms