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NCT00047619 · ClinicalTrials.gov registry record · Phase 2
Enhancement of Pressure Healing With Pulsatile Lavage
A Phase 2 study, sponsored by US Department of Veterans Affairs.
- Completed
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
NCT00047619: Completed Phase 2 study, sponsored by US Department of Veterans Affairs.
NCT00047619 is a Phase 2 study that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 28 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00047619, a Phase 2 study, has completed, sponsored by US Department of Veterans Affairs.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate the use of pulsatile lavage to enhance the healing of pressure ulcers in individuals with spinal cord injury (SCI). The goals will be achieved using a repeated-measures double-blinded randomized controlled study of individuals with SCI who have pelvic region pressure ulcers. A total of 60 subjects will be recruited to this study. Participants will be randomly assigned to a treatment or control group. Pulsatile lavage treatment will be administered to the treatment group daily for a 3 week period. The control group subjects will receive daily sham pulsatile lavage treatment for 3 weeks. All subjects will be monitored for a 3 week period and will continue to receive routine pressure ulcer care, i.e. dressings and bedrest with a regular turning regime during their participation in the study. All study participants will be monitored following the study period until complete closure of the pressure ulcer is achieved in order to determine total interval to final closure, including any surgical procedures required. In addition, the economic effects of pulsatile lavage treatment will be evaluated through monitoring of data collected in the Computerized Patient Record System (CPRS), including duration of admission, duration of total bedrest order and duration of treatment for pressure ulcer. This data will give an initial measure of the cost benefits that may be achieved with the use of pulsatile lavage for the treatment of pressure ulcers. Subjects will be recruited from the Louis Stokes Cleveland Veterans Affairs Medical Center (CVAMC). All individuals with spinal cord injury who are admitted to the SCI Unit with pelvic region pressure ulcers will be considered eligible for this study. Further selection criteria will be employed to screen potential participants as described below. On recruitment subjects will be randomly assigned to 2 groups of 20 subjects. The assessment methods employed will be the same for each volunteer. O
Primary Outcome
Linear assessment of wounds
Interventions
- PROCEDURE Pulsatile Lavage
- OTHER sham pulsatile lavage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2002-06 |
| Est. Completion | 2008-05 |
| Phase | Phase 2 |
What the finished NCT00047619 record still lists
NCT00047619 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 2 interventions - of which Pulsatile Lavage is the first listed.
NCT00047619 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00047619 about?
NCT00047619 is a clinical study titled "Enhancement of Pressure Healing With Pulsatile Lavage". The purpose of this study is to investigate the use of pulsatile lavage to enhance the healing of pressure ulcers in individuals with spinal cord injury (SCI). The goals will be achieved using a repeated-measures double-blinded randomized controlled study of individuals with SCI who have pelvic reg...
What is the current status of trial NCT00047619?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2002-06. Estimated completion is 2008-05.
What interventions are being tested in trial NCT00047619?
The interventions under investigation include: Pulsatile Lavage (PROCEDURE), sham pulsatile lavage (OTHER).
Who is sponsoring clinical trial NCT00047619?
This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00047619's enrollment target sits among peer trials
28 1677th of 2000 higher than 304 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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