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

January 6, 2012 updated by: Oscar M. Alvarez, PhD, Calvary Hospital, Bronx, NY

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10461
        • Center for Curative and Palliative wound Care, Calvary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Walking on a treadmill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Percent Reduction in Wound Surface Area
Time Frame: baseline and 16 weeks
baseline and 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Improvement in Peak Walking Time
Time Frame: 16 weeks
Percentage Improvement in the amount of time one can walk without pain
16 weeks
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.
16 weeks
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
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Calvary Hospital, Bronx, NY

Investigators

  • Principal Investigator: Oscar M Alvarez, PhD, Director Wound Care Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

August 18, 2011

First Submitted That Met QC Criteria

August 18, 2011

First Posted (Estimate)

August 19, 2011

Study Record Updates

Last Update Posted (Estimate)

February 9, 2012

Last Update Submitted That Met QC Criteria

January 6, 2012

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-HPIPC-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on PVD

Clinical Trials on High pressure intermittent pneumatic compression (HPIPC)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe