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Funding not available to continue with study.
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| Name | Class |
|---|---|
| NormaTec Industries LP | INDUSTRY |
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The purpose of this study is to determine how well different treatments for acquired lymphedema work.
The study will compare 5 different non-invasive treatments for acquired lymphedema of the arm to see which treats lymphedema best.
This study will compare 5 non-invasive lymphedema treatments.
Patients will be assigned to either:
- A combination of arm exercises, arm elevation, and wearing of a compression garment every day
OR
- One of four possible pneumatic compression devices for just two hours every day.
Pneumatic compression devices are made up of an inflatable sleeve connected to a small controller unit that is plugged into the wall. They feel like having your blood pressure taken.
None of the treatments are experimental. None of the treatments are invasive. All the treatments are considered standard of care and are used in clinics throughout the United States. All of the treatments will be done at home.
The trial will last for 7 and 1/2 months and will require follow-up visits to monitor progress.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Exercise, Elevation, and Garment Compression |
|
| Group B | Active Comparator | Pneumatic Compression Device (B) |
|
| Group C | Active Comparator | Pneumatic Compression Device (C) |
|
| Group D | Active Comparator | Pneumatic Compression Device (D) |
|
| Group E | Active Comparator | Pneumatic Compression Device (E) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise, Elevation, and Compression Garment | Other | Patients will be asked to daily:
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Arm Volume | Arm volume will be measured at 2 weeks before treatment starts, day treatment begins, and then 1 month, 3 months, 6 months, and 7 months after treatment starts |
| Measure | Description | Time Frame |
|---|---|---|
| Infection (cellulitis) | Presence of infection will be recorded at 2 weeks before treatment starts, day treatment begins, and then 1 month, 3 months, 6 months, and 7 months after treatment starts | |
| Quality of Life Survey | Survey will be given at 2 weeks before treatment starts, day treatment begins, and then 1 month, 3 months, 6 months, and 7 months after treatment starts |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arin K Greene, MD, MMSc | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Boston at Waltham | Waltham | Massachusetts | 02453 | United States |
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| E0650 PCD with non-sequential waveform | Device | Use of an E0650 PCD with non-sequential waveform for two hours every day. |
|
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| E0651 PCD with sequential, non-gradient waveform | Device | Use of an E0651 PCD with sequential, non-gradient waveform for two hours every day |
|
|
| E0652 PCD with sequential, gradient waveform | Device | Use of an E0652 PCD with sequential, gradient waveform for two hours every day. |
|
|
| E0652 PCD with peristaltic pulse waveform | Device | Use the E0652 PCD with peristaltic pulse waveform for two hours every day. |
|
|
| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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