Enhancement of Pressure Healing With Pulsatile Lavage
Public ClinicalTrials.gov record NCT00047619. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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. One group will participate in the pulsatile lavage intervention, the second group will act as controls.
Study identification
- NCT ID
- NCT00047619
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 28 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2002
- Primary completion
- Apr 30, 2008
- Completion
- Apr 30, 2008
- Last update posted
- Oct 4, 2015
2002 – 2008
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| VA Medical Center, Cleveland | Cleveland | Ohio | 44106 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00047619, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 4, 2015 · Synced Sep 12, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00047619 live on ClinicalTrials.gov.