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| Name | Class |
|---|---|
| RTS Family Foundation | UNKNOWN |
| New York State Department of Health | OTHER_GOV |
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This is a randomized, controlled, parallel group, open label, clinical trial to evaluate the effectiveness of intermittent, gradient, pneumatic compression (IPC)on the healing of venous ulcers in subjects diagnosed with chronic secondary lymphedema. Time to complete healing, healing rates, edema, wound pain, granulation tissue, and wound exudate (type and amount) will be compared between the IPC-treated group (IPC plus standard compression)and control (standard compression alone).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IPC plus standard compression | Experimental |
| |
| Standard compression alone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent, gradient, pneumatic compression device | Device | lymphedema pump provides external compression in a segmental,gradient fashion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median Time to Wound Closure at 9 Months | Median number of days for complete healing in each treatment group | 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Calvary Hospital, Center for Curative and Palliative Wound Care | The Bronx | New York | 10461 | United States |
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52 subjects were treated, IPC n=27, Control n=25
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| ID | Title | Description |
|---|---|---|
| FG000 | IPC Plus Standard Compression | |
| FG001 | Standard Compression Alone |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IPC Plus Standard Compression | |
| BG001 | Standard Compression Alone | |
| BG002 | Total |
| 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 | Median Time to Wound Closure at 9 Months | Median number of days for complete healing in each treatment group | Posted | Median | Standard Error | median number of days for complete heali | 9 months |
|
|
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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 | IPC Plus Standard Compression |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Oscar M. Alvarez / Principal Investigator | Center for Curative and Palliative Wound Care Calvary Hospital | 718-518-2577 | oalvarez@calvaryhospital.org |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
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|
Total of all reporting groups
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Standard Compression Alone | 0 | 25 | 0 | 25 |
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| D002318 |
| Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |