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NCT02395302 · ClinicalTrials.gov registry record · NA
Evaluation of a Dual Action Pneumatic Compression System: Tolerance and Comfort in Patients With Venous Leg Ulcers (VLUs)
A NA study of Venous Leg Ulcer and Venous Ulcer, sponsored by Tactile Medical.
- Completed
- Registry status
- NA
- Development phase
- 28
- Enrollment target
- 6
- Study locations
NCT02395302: Completed NA study of Venous Leg Ulcer and Venous Ulcer, sponsored by Tactile Medical.
NCT02395302 is a NA study of Venous Leg Ulcer and Venous Ulcer that has completed, run by Tactile Medical. The registered enrollment target is 28 participants, below the 244-participant average among 35 other Venous Leg Ulcer trials with a reported enrollment target (89% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02395302, a NA study of Venous Leg Ulcer and Venous Ulcer, has completed, sponsored by Tactile Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 28 participants
- Enrollment target
- 6
- Study locations
Study Summary
The purpose of the study is to assess treatment tolerance and comfort in chronic VLUs after 4 weeks of treatment using a dual action pneumatic compression device.
Primary Outcome
A questionnaire that was completed after receiving four weeks of treatment from a dual action pneumatic compression device. Questions listed below: 1. The device was comfortable to wear during Sustained Compression Mode. 2. The device was comfortable to wear during Intermittent Compression Mode. 3. The noise from the device was not bothersome. 4. The device was easy to put on. 5. The device was easy to take off. 6. The device was easy to use. 7. The device was light-weight and portable. 8. The
Conditions Studied
Interventions
- DEVICE Dual Action Pneumatic Compression
Study Locations (6)
Massachusetts
- Tufts Medical Center - Boston
- Boston Medical Center - Boston
California
- Center for Clinical Research - San Francisco
Florida
- University of Miami School Hospital - Miami
New Jersey
- Englewood Hospital and Medical Center - Englewood
New York
- St. Luke's Roosevelt Hospital Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2014-12 |
| Est. Completion | 2015-11 |
| Phase | NA |
What the finished NCT02395302 record still lists
NCT02395302 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 244-participant average among 35 other Venous Leg Ulcer trials with a reported enrollment target (89% lower).
The record links to 5 conditions, with Venous Leg Ulcer appearing as the primary indexed condition, and to 1 intervention - of which Dual Action Pneumatic Compression is the first listed.
NCT02395302 lists 6 locations in 5 states (Massachusetts, California, Florida).
Frequently Asked Questions
What is clinical trial NCT02395302 about?
NCT02395302 is a clinical study titled "Evaluation of a Dual Action Pneumatic Compression System: Tolerance and Comfort in Patients With Venous Leg Ulcers (VLUs)". The purpose of the study is to assess treatment tolerance and comfort in chronic VLUs after 4 weeks of treatment using a dual action pneumatic compression device.
What is the current status of trial NCT02395302?
This trial is currently completed. It is a NA study. The enrollment target is 28 participants. The study started on 2014-12. Estimated completion is 2015-11.
What conditions does trial NCT02395302 study?
This clinical trial studies the following conditions: Venous Leg Ulcer, Venous Ulcer, Venous Insufficiency, Venous Stasis Ulcer, Chronic Venous Insufficiency.
What interventions are being tested in trial NCT02395302?
The interventions under investigation include: Dual Action Pneumatic Compression (DEVICE).
Who is sponsoring clinical trial NCT02395302?
This trial is sponsored by Tactile Medical, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02395302 being conducted?
This trial has 6 study locations across California, Florida, Massachusetts, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02395302's enrollment target sits among peer trials
28 32nd of 35 higher than 4 of 35 other Venous Leg Ulcer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Venous Leg Ulcer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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