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To evaluate the effects of HPIPC for the treatment of symptoms of PAD
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPIPC | Experimental | High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 45 minutes twice daily |
|
| Excercise | Active Comparator | Walking on a graded treadmill for 45 minutes once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High pressure intermittent pneumatic compression (HPIPC) | Device | Apply therapy for 45 minutes twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Reduction in Wound Surface Area | baseline and 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Improvement in Peak Walking Time | Percentage Improvement in the amount of time one can walk without pain | 16 weeks |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oscar M Alvarez, PhD | Director Wound Care Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Curative and Palliative wound Care, Calvary Hospital | The Bronx | New York | 10461 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | HPIPC | High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily |
| FG001 | Excercise | Walking on a graded treadmill for 45 minutes once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HPIPC | High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily |
| BG001 | Excercise | Walking on a graded treadmill for 45 minutes once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Percent Reduction in Wound Surface Area | Posted | Mean | Standard Error | Percent reduction in wound surface area | baseline and 16 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HPIPC | High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Oscar M. Alvarez PhD, Director Center for Curative and Palliative Wound Care | Calvary Hospital | 718-518-2577 | oalvarez@calvaryhospital.org |
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| Excercise | Behavioral | Treadmill walking 45 minutes once daily |
|
|
| 16 weeks |
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Percent Improvement in Peak Walking Time | Percentage Improvement in the amount of time one can walk without pain | Posted | Mean | Standard Error | Percentage Change | 16 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Error | Percent improvement in Sf-36 QOL score | 16 weeks |
|
|
|
| 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 | Posted | Mean | Standard Error | Percent improvement in mean VAS pain sco | 16 weeks |
|
|
|
| 0 |
| 16 |
| 0 |
| 18 |
| EG001 | Excercise | Walking on a graded treadmill for 45 minutes once daily | 0 | 16 | 0 | 16 |
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