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

NCT ID: NCT01420289

Last Updated: 2012-02-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-06-30

Brief Summary

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

Detailed Description

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Conditions

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PVD Arterial Ulcers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HPIPC

High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 45 minutes twice daily

Group Type EXPERIMENTAL

High pressure intermittent pneumatic compression (HPIPC)

Intervention Type DEVICE

Apply therapy for 45 minutes twice daily

Excercise

Walking on a graded treadmill for 45 minutes once daily

Group Type ACTIVE_COMPARATOR

Excercise

Intervention Type BEHAVIORAL

Treadmill walking 45 minutes once daily

Interventions

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High pressure intermittent pneumatic compression (HPIPC)

Apply therapy for 45 minutes twice daily

Intervention Type DEVICE

Excercise

Treadmill walking 45 minutes once daily

Intervention Type BEHAVIORAL

Other Intervention Names

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Bio Arterial Plus Art Assist Walking on a treadmill

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Calvary Hospital, Bronx, NY

OTHER

Sponsor Role lead

Responsible Party

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Oscar M. Alvarez, PhD

Director, Center for Curative andPalliative Wound Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oscar M Alvarez, PhD

Role: PRINCIPAL_INVESTIGATOR

Director Wound Care Center

Locations

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Center for Curative and Palliative wound Care, Calvary Hospital

The Bronx, New York, United States

Site Status

Countries

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United States

Other Identifiers

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01-HPIPC-09

Identifier Type: -

Identifier Source: org_study_id

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