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

Primary Purpose

PVD, Arterial Ulcers

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

High pressure intermittent pneumatic compression (HPIPC)

Excercise

About this trial

This is an interventional treatment trial for PVD focused on measuring Ischemic ulcers, PAD, Intermittent Claudication Pain

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Center for Curative and Palliative wound Care, Calvary Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HPIPC

Excercise

Arm Description

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

Walking on a graded treadmill for 45 minutes once daily

Outcomes

Primary Outcome Measures

Mean Percent Reduction in Wound Surface Area

Secondary Outcome Measures

Percent Improvement in Peak Walking Time

Percentage Improvement in the amount of time one can walk without pain

Perceived Improvement in Physical Function After 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.

Percent change (improvement)in mean VAS pain scores at baseline and at 16 weeks

Full Information

NCT ID

NCT01420289

First Posted

August 18, 2011

Last Updated

January 6, 2012

Sponsor

Calvary Hospital, Bronx, NY

1. Study Identification

Unique Protocol Identification Number

NCT01420289

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Calvary Hospital, Bronx, NY

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

PVD, Arterial Ulcers

Keywords

Ischemic ulcers, PAD, Intermittent Claudication Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HPIPC

Arm Type

Experimental

Arm Description

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

Arm Title

Excercise

Arm Type

Active Comparator

Arm Description

Walking on a graded treadmill for 45 minutes once daily

Intervention Type

Device

Intervention Name(s)

High pressure intermittent pneumatic compression (HPIPC)

Other Intervention Name(s)

Bio Arterial Plus, Art Assist

Intervention Description

Apply therapy for 45 minutes twice daily

Intervention Type

Behavioral

Intervention Name(s)

Excercise

Other Intervention Name(s)

Walking on a treadmill

Intervention Description

Treadmill walking 45 minutes once daily

Primary Outcome Measure Information:

Title

Mean Percent Reduction in Wound Surface Area

Time Frame

baseline and 16 weeks

Secondary Outcome Measure Information:

Title

Percent Improvement in Peak Walking Time

Description

Percentage Improvement in the amount of time one can walk without pain

Time Frame

16 weeks

Title

Perceived Improvement in Physical Function After 16 Weeks

Description

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.

Time Frame

16 weeks

Title

Wound Pain as Determined by a Visual Analog 10 Point Scale (VAS) for Pain.

Description

Percent change (improvement)in mean VAS pain scores at baseline and at 16 weeks

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Oscar M Alvarez, PhD

Organizational Affiliation

Director Wound Care Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Center for Curative and Palliative wound Care, Calvary Hospital

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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