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

Calvary Hospital, Bronx, NY

Status: Completed

Conditions: Arterial Ulcers; PVD

Treatments: Behavioral: Excercise; Device: High pressure intermittent pneumatic compression (HPIPC)

Study type: Interventional

Funder types: Other

Identifiers

NCT01420289

01-HPIPC-09

Details and patient eligibility

About

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

Enrollment: 44 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

HPIPC

Experimental group

Description:

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

Treatment:

Device: High pressure intermittent pneumatic compression (HPIPC)

Excercise

Active Comparator group

Description:

Walking on a graded treadmill for 45 minutes once daily

Treatment:

Behavioral: Excercise