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OpenTrials
Completed

NCT Number: NCT01420289

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

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

Completed

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Key information

Conditions

PVD Arterial Ulcers

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Curative and Palliative wound Care, Calvary Hospital

The Bronx, New York, 10461, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High pressure intermittent pneumatic compression (HPIPC)

Device

Apply therapy for 45 minutes twice daily

Other names: Bio Arterial Plus, Art Assist

Excercise

Behavioral

Treadmill walking 45 minutes once daily

Other names: Walking on a treadmill

Primary outcomes

  1. Mean Percent Reduction in Wound Surface Area

    Time frame: baseline and 16 weeks

Secondary outcomes

  1. Percent Improvement in Peak Walking Time

    Time frame: 16 weeks

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

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Calvary Hospital, Bronx, NY

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 19, 2011
Registry last updated
Feb 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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