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

PVD Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01420289
• Other study ID #: 01-HPIPC-09
• Status: Completed
• Phase: N/A
• First received: August 18, 2011
• Last updated: January 6, 2012
• Start date: January 2009
• Est. completion date: June 2011

Study information

• Verified date: August 2011
• Source: Calvary Hospital, Bronx, NY
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arterial Ulcers
• Intermittent Claudication
• PVD
• Ulcer

Intervention

Device:
• High pressure intermittent pneumatic compression (HPIPC)
Apply therapy for 45 minutes twice daily

Behavioral:
• Excercise
Treadmill walking 45 minutes once daily

Locations

Country	Name	City	State
United States	Center for Curative and Palliative wound Care, Calvary Hospital	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Calvary Hospital, Bronx, NY

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Percent Reduction in Wound Surface Area		baseline and 16 weeks	No
Secondary	Percent Improvement in Peak Walking Time	Percentage Improvement in the amount of time one can walk without pain	16 weeks	No
Secondary	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.	16 weeks	No
Secondary	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	16 weeks	No