ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01420289
Recruitment Status : Completed
First Posted : August 19, 2011
Results First Posted : February 9, 2012
Last Update Posted : February 9, 2012
Sponsor:
Information provided by (Responsible Party):
Oscar M. Alvarez, PhD, Calvary Hospital, Bronx, NY

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions PVD
Arterial Ulcers
Interventions Device: High pressure intermittent pneumatic compression (HPIPC)
Behavioral: Excercise
Enrollment 44
Recruitment Details  
Pre-assignment Details  
Arm/Group Title HPIPC Excercise
Hide Arm/Group Description High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily Walking on a graded treadmill for 45 minutes once daily
Period Title: Overall Study
Started 18 16
Completed 18 16
Not Completed 0 0
Arm/Group Title HPIPC Excercise Total
Hide Arm/Group Description High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily Walking on a graded treadmill for 45 minutes once daily Total of all reporting groups
Overall Number of Baseline Participants 18 16 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 34 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
  77.8%
14
  87.5%
28
  82.4%
>=65 years
4
  22.2%
2
  12.5%
6
  17.6%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 16 participants 34 participants
64  (12) 62  (11) 63  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 34 participants
Female
6
  33.3%
6
  37.5%
12
  35.3%
Male
12
  66.7%
10
  62.5%
22
  64.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants 16 participants 34 participants
18 16 34
1.Primary Outcome
Title Mean Percent Reduction in Wound Surface Area
Hide Description [Not Specified]
Time Frame baseline and 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HPIPC Excercise
Hide Arm/Group Description:
High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
Walking on a graded treadmill for 45 minutes once daily
Overall Number of Participants Analyzed 18 16
Mean (Standard Error)
Unit of Measure: Percent reduction in wound surface area
72  (22) 58  (15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HPIPC, Excercise
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.086
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 14
Confidence Interval (2-Sided) 95%
10 to 80
Parameter Dispersion
Type: Standard Error of the mean
Value: 15
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percent Improvement in Peak Walking Time
Hide Description Percentage Improvement in the amount of time one can walk without pain
Time Frame 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HPIPC Excercise
Hide Arm/Group Description:
High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
Walking on a graded treadmill for 45 minutes once daily
Overall Number of Participants Analyzed 18 16
Mean (Standard Error)
Unit of Measure: Percentage Change
96  (11) 66  (9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HPIPC, Excercise
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 30
Confidence Interval (2-Sided) 95%
10 to 100
Parameter Dispersion
Type: Standard Error of the mean
Value: 11
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Perceived Improvement in Physical Function After 16 Weeks
Hide Description

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.

Time Frame 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HPIPC Excercise
Hide Arm/Group Description:
High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
Walking on a graded treadmill for 45 minutes once daily
Overall Number of Participants Analyzed 18 16
Mean (Standard Error)
Unit of Measure: Percent improvement in Sf-36 QOL score
70  (6) 53  (6)
4.Secondary Outcome
Title Wound Pain as Determined by a Visual Analog 10 Point Scale (VAS) for Pain.
Hide Description Percent change (improvement)in mean VAS pain scores at baseline and at 16 weeks
Time Frame 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HPIPC Excercise
Hide Arm/Group Description:
High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
Walking on a graded treadmill for 45 minutes once daily
Overall Number of Participants Analyzed 18 16
Mean (Standard Error)
Unit of Measure: Percent improvement in mean VAS pain sco
80  (14) 55  (9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title HPIPC Excercise
Hide Arm/Group Description High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily Walking on a graded treadmill for 45 minutes once daily
All-Cause Mortality
HPIPC Excercise
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
HPIPC Excercise
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
HPIPC Excercise
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/16 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Oscar M. Alvarez PhD, Director Center for Curative and Palliative Wound Care
Organization: Calvary Hospital
Phone: 718-518-2577
Responsible Party: Oscar M. Alvarez, PhD, Calvary Hospital, Bronx, NY
ClinicalTrials.gov Identifier: NCT01420289     History of Changes
Other Study ID Numbers: 01-HPIPC-09
First Submitted: August 18, 2011
First Posted: August 19, 2011
Results First Submitted: August 22, 2011
Results First Posted: February 9, 2012
Last Update Posted: February 9, 2012