Effect of HPIPC for the Treatment of Ischemic Ulcers in Subjects With PAD
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
1 other identifier
interventional
44
1 country
1
Brief Summary
To evaluate the effects of HPIPC for the treatment of symptoms of PAD
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 18, 2011
CompletedFirst Posted
Study publicly available on registry
August 19, 2011
CompletedResults Posted
Study results publicly available
February 9, 2012
CompletedFebruary 9, 2012
August 1, 2011
2.4 years
August 18, 2011
August 22, 2011
January 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Percent Reduction in Wound Surface Area
baseline and 16 weeks
Secondary Outcomes (3)
Percent Improvement in Peak Walking Time
16 weeks
Perceived Improvement in Physical Function After 16 Weeks
16 weeks
Wound Pain as Determined by a Visual Analog 10 Point Scale (VAS) for Pain.
16 weeks
Study Arms (2)
HPIPC
EXPERIMENTALHigh Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 45 minutes twice daily
Excercise
ACTIVE COMPARATORWalking on a graded treadmill for 45 minutes once daily
Interventions
Apply therapy for 45 minutes twice daily
Treadmill walking 45 minutes once daily
Eligibility Criteria
You may qualify if:
- Intermittent claudication \>6mo
- Ischemic ulceration or ulcer of mixed (venous) etiology
- ABI \< 0.7
- Ambulatory
- Able to comply
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Curative and Palliative wound Care, Calvary Hospital
The Bronx, New York, 10461, United States
Results Point of Contact
- Title
- Oscar M. Alvarez PhD, Director Center for Curative and Palliative Wound Care
- Organization
- Calvary Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Oscar M Alvarez, PhD
Director Wound Care Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Center for Curative andPalliative Wound Care
Study Record Dates
First Submitted
August 18, 2011
First Posted
August 19, 2011
Study Start
January 1, 2009
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
February 9, 2012
Results First Posted
February 9, 2012
Record last verified: 2011-08