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NCT01239160 · ClinicalTrials.gov registry record · NA
Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema
A NA study, sponsored by Tactile Medical.
- Terminated
- Registry status
- NA
- Development phase
- 238
- Enrollment target
NCT01239160 is a NA study that was terminated before completion, run by Tactile Medical. The registered enrollment target is 238 participants.
The verdict
NCT01239160, a NA study, was terminated before completion, sponsored by Tactile Medical.
- TERMINATED
- Registry status
- NA
- Development phase
- 238 participants
- Enrollment target
Study Summary
The treatment of lymphedema has been a major focus of attention for physicians and scientists for several decades. At this time, no successful techniques have been developed to prevent lymphedema, and therefore, a great deal of emphasis is placed on treatment modalities that can lessen the severity and impede the progression of this debilitating condition. The treatment on offer usually consists of a maintenance phase using compression garments and an intensive treatment phase, which includes the use of skin care, compression bandaging, exercise and manual lymphatic drainage (MLD). The intensive phase is usually described as complex decongestive therapy (CDT). This is time consuming and requires high resource usage. Pneumatic compression devices (PCD) offer and alternative to MLD and can be used by the patient. There are a number of devices on the market that are categorized into 1. without calibrated gradient compression 2. With calibrated gradient compression. This trial will compare two PCDs, a simple device without calibrated compression, and an advanced device with calibrated compression, in the reduction of swelling and maintenance of reduced limb volume in 262 patients with lower limb lymphoedema. The primary end point will be limb volume reduction over 12 weeks of treatment, with secondary outcome after 24 weeks.
Interventions
- DEVICE Flexitouch System
- DEVICE Hydroven FPR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 238 participants |
| Start Date | 2010-11-02 |
| Est. Completion | 2012-06-27 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01239160
The ClinicalTrials.gov registry entry for NCT01239160 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 238 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tactile Medical, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Flexitouch System is the first listed.
NCT01239160 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01239160 about?
NCT01239160 is a clinical study titled "Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema". The treatment of lymphedema has been a major focus of attention for physicians and scientists for several decades. At this time, no successful techniques have been developed to prevent lymphedema, and therefore, a great deal of emphasis is placed on treatment modalities that can lessen the severity ...
What is the current status of trial NCT01239160?
This trial is currently terminated. It is a NA study. The enrollment target is 238 participants. The study started on 2010-11-02. Estimated completion is 2012-06-27.
What interventions are being tested in trial NCT01239160?
The interventions under investigation include: Flexitouch System (DEVICE), Hydroven FPR (DEVICE).
Who is sponsoring clinical trial NCT01239160?
This trial is sponsored by Tactile Medical, which has 14 total clinical trials registered on ClinicalTrials.gov.
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