N/A N=34 Randomized Treatment

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

PVD · Arterial Ulcers

Bottom Line

View on ClinicalTrials.gov: NCT01420289 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2012

Primary outcome: Primary: Mean Percent Reduction in Wound Surface Area — 72; 58 Percent reduction in wound surface area — p=0.086

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: High pressure intermittent pneumatic compression (HPIPC) (Device); Excercise (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Calvary Hospital, Bronx, NY
Primary completion: Jun 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Percent Reduction in Wound Surface Area	72; 58	0.086
SECONDARY Percent Improvement in Peak Walking Time	96; 66	<0.05 sig
SECONDARY Perceived Improvement in Physical Function After 16 Weeks	70; 53	—
SECONDARY Wound Pain as Determined by a Visual Analog 10 Point Scale (VAS) for Pain.	80; 55	—

Summary

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01420289). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.