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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oscar M. Alvarez, PhD, Calvary Hospital, Bronx, NY
ClinicalTrials.gov Identifier:
NCT01420289
First received: August 18, 2011
Last updated: January 6, 2012
Last verified: August 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Calvary Hospital, Bronx, NY:

Primary Outcome Measures:
  • Mean Percent Reduction in Wound Surface Area [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent Improvement in Peak Walking Time [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Percentage Improvement in the amount of time one can walk without pain

  • Perceived Improvement in Physical Function After 16 Weeks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: August 18, 2011
Results First Received: August 22, 2011
Last Updated: January 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Calvary Hospital, Bronx, NY:
Ischemic ulcers
PAD
Intermittent Claudication Pain

Additional relevant MeSH terms:
Intermittent Claudication
Ulcer
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014