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NCT00628602 · ClinicalTrials.gov registry record · Phase 1
BION Active Seating for Pressure Ulcer Prevention
A Phase 1 study of Pressure Ulcer, sponsored by University of Southern California.
- Completed
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
- 1
- Study location
NCT00628602 is a Phase 1 study of Pressure Ulcer that has completed, run by University of Southern California. The registered enrollment target is 3 participants, below the 30,117-participant average among 10 other Pressure Ulcer trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00628602, a Phase 1 study of Pressure Ulcer, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
- 1
- Study location
Study Summary
Pressure ulcers (PUs) are a debilitating pathology resulting from pressure and shear in the soft tissues of immobilized patients. In studies to date, BION neuromuscular stimulation has been demonstrated to activate strong muscle contractions and to produce skeletal motion, with associated increases in muscle bulk (hypertrophy), strength, and metabolic capacity, hence counteracting the 3 major etiological factors in PU development (immobility, soft-tissue atrophy and hypoxia). This study intends to use neuromuscular stimulation to both shift paralyzed subjects' weight and build up gluteal muscle volume, in order to prevent recurrence of pressure ulcers. We will implant BIONs alongside the already exposed inferior gluteal and sciatic nerves in patients who are undergoing gluteal rotation flap surgery for PU reconstruction. The gluteal rotation flap is a common reconstructive technique for treating PUs by bringing healthy muscle and skin in to repair the deficient area, and to provide healthy tissue covering over bony prominences. The implanted BIONs will enable us subsequently to stimulate the gluteus maximus and hip extensor muscles. Outcome measures will include tissue health variables (measured by clinical assessment, X-Rays, MRI and Sesta-MIBI SPECT perfusion scans), pressure redistribution (measured by an array of pressure sensors), and recurrence rates over 12 months.
Conditions Studied
Interventions
- DEVICE BION
Study Locations (1)
California
- Rancho Los Amigos National Rehabilitation Center - Downey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2007-11 |
| Est. Completion | 2008-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00628602
The ClinicalTrials.gov registry entry for NCT00628602 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 30,117-participant average among 10 other Pressure Ulcer trials with a reported enrollment target (100% lower). The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pressure Ulcer appearing as the primary indexed condition, and to 1 intervention - of which BION is the first listed.
NCT00628602 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT00628602 about?
NCT00628602 is a clinical study titled "BION Active Seating for Pressure Ulcer Prevention". Pressure ulcers (PUs) are a debilitating pathology resulting from pressure and shear in the soft tissues of immobilized patients. In studies to date, BION neuromuscular stimulation has been demonstrated to activate strong muscle contractions and to produce skeletal motion, with associated increases ...
What is the current status of trial NCT00628602?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2007-11. Estimated completion is 2008-12.
What conditions does trial NCT00628602 study?
This clinical trial studies the following conditions: Pressure Ulcer.
What interventions are being tested in trial NCT00628602?
The interventions under investigation include: BION (DEVICE).
Who is sponsoring clinical trial NCT00628602?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00628602 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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