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

N/ACompletedNCT01420289

Calvary Hospital, Bronx, NY44 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

PVD Arterial Ulcers

Interventions

High pressure intermittent pneumatic compression (HPIPC)DEVICE

Apply therapy for 45 minutes twice daily

ExcerciseBEHAVIORAL

Treadmill walking 45 minutes once daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Center for Curative and Palliative wound Care, Calvary Hospital

The Bronx, New York, United States

Outcomes

Primary Outcomes

Mean Percent Reduction in Wound Surface Area

Time frame: baseline and 16 weeks

Secondary Outcomes

Percent Improvement in Peak Walking Time

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

Time frame: 16 weeks

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.

Time frame: 16 weeks

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

Time frame: 16 weeks

Data from ClinicalTrials.gov

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