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NCT02519621 · ClinicalTrials.gov registry record · NA
NPWT PRO vs KCI Ulta® NPWT and to Compare NPWT PRO vs NPWT PRO With Simultaneous Irrigation on Wound Healing
A NA study of Ulcer and Partial-thickness Burn, sponsored by Larry Lavery.
- Completed
- Registry status
- NA
- Development phase
- 90
- Enrollment target
- 2
- Study locations
NCT02519621: Completed NA study of Ulcer and Partial-thickness Burn, sponsored by Larry Lavery.
NCT02519621 is a NA study of Ulcer and Partial-thickness Burn that has completed, run by Larry Lavery. The registered enrollment target is 90 participants, below the 209-participant average among 13 other Ulcer trials with a reported enrollment target (57% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02519621, a NA study of Ulcer and Partial-thickness Burn, has completed, sponsored by Larry Lavery.
- COMPLETED
- Registry status
- NA
- Development phase
- 90 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study is designed to assess the efficacy and economics of two NPWT (negative pressure wound therapy) branded devices of wound healing outcomes. It is also designed to assess the effectiveness of negative pressure and negative pressure with continuous irrigation on multiple parameters of wound healing. It is a single-center, open-label, active controlled, parallel-group trial that aims to determine the efficacy of Quantum with simultaneous irrigation in the treatment of diabetic foot ulcers. Specifically, eligible participants will be randomized to receive either PRO negative press therapy with simultaneous irrigation; or PRO negative pressure therapy without irrigation; or KCI Ulta negative pressure therapy. Outcomes will include rates of wound healing, time to closure, number of surgeries, length of stay, and days to heal.
Primary Outcome
Complete healing of wounds as defined by epithelialization with no drainage in three treatment arms: NPWT PRO versus KCI Ulta® NPWT and to Compare NPWT PRO versus NPWT PRO with Simultaneous Irrigation
Conditions Studied
Interventions
- DEVICE NPWT PRO without irrigation
- DEVICE NPWT PRO with irrigation
- DEVICE KCI Ulta
Study Locations (2)
Texas
- UT Southwestern Medical Center - Dallas
- UT Southwestern - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2016-04 |
| Est. Completion | 2020-06-24 |
| Phase | NA |
What the finished NCT02519621 record still lists
NCT02519621 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 209-participant average among 13 other Ulcer trials with a reported enrollment target (57% lower).
The record links to 2 conditions, with Ulcer appearing as the primary indexed condition, and to 3 interventions - of which NPWT PRO without irrigation is the first listed.
NCT02519621 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02519621 about?
NCT02519621 is a clinical study titled "NPWT PRO vs KCI Ulta® NPWT and to Compare NPWT PRO vs NPWT PRO With Simultaneous Irrigation on Wound Healing". This study is designed to assess the efficacy and economics of two NPWT (negative pressure wound therapy) branded devices of wound healing outcomes. It is also designed to assess the effectiveness of negative pressure and negative pressure with continuous irrigation on multiple parameters of wound h...
What is the current status of trial NCT02519621?
This trial is currently completed. It is a NA study. The enrollment target is 90 participants. The study started on 2016-04. Estimated completion is 2020-06-24.
What conditions does trial NCT02519621 study?
This clinical trial studies the following conditions: Ulcer, Partial-thickness Burn.
What interventions are being tested in trial NCT02519621?
The interventions under investigation include: NPWT PRO without irrigation (DEVICE), NPWT PRO with irrigation (DEVICE), KCI Ulta (DEVICE).
Who is sponsoring clinical trial NCT02519621?
This trial is sponsored by Larry Lavery, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02519621 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02519621's enrollment target sits among peer trials
90 10th of 13 higher than 4 of 13 other Ulcer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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