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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 is a Phase 2 study that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 28 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00047619
The ClinicalTrials.gov registry entry for NCT00047619 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is US Department of Veterans Affairs, which has 632 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Pulsatile Lavage is the first listed.
NCT00047619 reports 0 study locations.
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.
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