Trial Outcomes & Findings for Effect of HPIPC for the Treatment of Ischemic Ulcers in Subjects With PAD (NCT NCT01420289)

NCT ID: NCT01420289

Last Updated: 2012-02-09

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 44 participants
• Primary outcome timeframe: baseline and 16 weeks
• Results posted on: 2012-02-09

Participant Flow

Participant milestones

Measure	HPIPC High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily	Excercise Walking on a graded treadmill for 45 minutes once daily
Overall Study STARTED	18	16
Overall Study COMPLETED	18	16
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	HPIPC n=18 Participants High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily	Excercise n=16 Participants Walking on a graded treadmill for 45 minutes once daily	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Age Continuous	64 years STANDARD_DEVIATION 12 • n=5 Participants	62 years STANDARD_DEVIATION 11 • n=7 Participants	63 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants	16 participants n=7 Participants	34 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 16 weeks

Outcome measures

Measure	HPIPC n=18 Participants High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily	Excercise n=16 Participants Walking on a graded treadmill for 45 minutes once daily
Mean Percent Reduction in Wound Surface Area	72 Percent reduction in wound surface area Standard Error 22	58 Percent reduction in wound surface area Standard Error 15

SECONDARY outcome

Timeframe: 16 weeks

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

Outcome measures

Measure	HPIPC n=18 Participants High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily	Excercise n=16 Participants Walking on a graded treadmill for 45 minutes once daily
Percent Improvement in Peak Walking Time	96 Percentage Change Standard Error 11	66 Percentage Change Standard Error 9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	HPIPC n=18 Participants High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily	Excercise n=16 Participants Walking on a graded treadmill for 45 minutes once daily
Perceived Improvement in Physical Function After 16 Weeks	70 Percent improvement in Sf-36 QOL score Standard Error 6	53 Percent improvement in Sf-36 QOL score Standard Error 6

SECONDARY outcome

Timeframe: 16 weeks

Percent change (improvement)in mean VAS pain scores at baseline and at 16 weeks

Outcome measures

Measure	HPIPC n=18 Participants High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily	Excercise n=16 Participants Walking on a graded treadmill for 45 minutes once daily
Wound Pain as Determined by a Visual Analog 10 Point Scale (VAS) for Pain.	80 Percent improvement in mean VAS pain sco Standard Error 14	55 Percent improvement in mean VAS pain sco Standard Error 9

Adverse Events

HPIPC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Excercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Oscar M. Alvarez PhD, Director Center for Curative and Palliative Wound Care

Calvary Hospital

Phone: 718-518-2577

Email: oalvarez@calvaryhospital.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place