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staffing change and lack of resources to conduct the study.
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This is a two arm, prospective, single center, randomized clinical trial. Subjects will be randomly assigned into one of two groups using block randomization technique in a 1:1 ratio. The control group will receive care using elastic compression stocking and the intervention group will use the ACTitouch device. Stratified randomization will occur based on whether the Deep Vein Thrombosis (DVT) has iliac or non-iliac involvement. Subjects will be followed for 2 years with clinic visits occurring at 1, 3, 6, 12, and 24 months.
The purpose of this study is to determine if use of a pneumatic compression device (ACTitouch, Tactile Medical) is beneficial in improving or preventing the development of Post Thrombotic Syndrome (PTS). 84 patients who have a history of an acute proximal unilateral leg DVT diagnosed one or more months prior to enrollment, or diagnosed with a chronic proximal unilateral leg DVT at time of enrollment, on duplex or other imaging study will be randomized into two groups: the control group receiving the standard of care compression stockings and the intervention group receiving ACTitouch device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACTitouch - ACT-Adaptive Compression Therapy | Experimental | a dual treatment pneumatic compression device offering two operational modes: sustained compression mode and intermittent compression mode. The device is applied to the lower leg (calf, ankle, and foot) and consists of an under-sock worn against the skin, a compression sleeve containing 4 inflatable chambers and a controller unit. The controller provides the airflow to inflate the chambers and monitors and adjusts the chamber pressure to maintain the intended treatment pressures. |
|
| Standard Compression Stocking | Experimental | The control group will receive care using elastic compression stocking. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACTitouch | Device | The device is applied to the lower leg (calf, ankle, and foot) and consists of an under-sock worn against the skin, a compression sleeve containing 4 inflatable chambers and a controller unit. The controller provides the airflow to inflate the chambers and monitors and adjusts the chamber pressure to maintain the intended treatment pressures. |
| Measure | Description | Time Frame |
|---|---|---|
| Villalta Score | The Villalta score is a disease score specific for PTS. It can be used to both diagnose and categorize the severity of the condition. It was developed in a cross-sectional study of 100 patients who were assessed 6 to 36 months after DVT.
| 2 Years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Maldonado, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
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| ID | Term |
|---|---|
| D054070 | Postthrombotic Syndrome |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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subjects who meet the study entrance criteria will be randomly assigned into one of two groups using block randomization technique in a 1:1 ratio. The control group will receive care using elastic compression stocking and the intervention group will use the ACTitouch device. Stratified randomization will occur based on whether the DVT has iliac or non-iliac involvement.
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| Compression garments (stockings) | Device | Compression garments (stockings) now serve as the generally recommended standard of care for patients post DVT and will be utilized as the control compression method in this study. Compression garments utilized in this study will be "below the knee" style with a pressure range of 30-40 mmHg. If a patient does not have compression garments as indicated, these stockings will be provided. |
|
| D014689 |
| Venous Insufficiency |