Status:
WITHDRAWN
BIONs, for Improved Tissue Health and Pressure Sore Prevention
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Pressure Ulcers
Spinal Cord Injury
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of this study was to determine the feasibility of an implanted electrical stimulation system incorporating BION microstimulators for long term use to prevent tissue breakdown in high risk ...
Detailed Description
The overall goal of this project was to implement the use of a gluteal stimulation system incorporating BION microstimulators for pressure ulcer prevention in patients at high risk of tissue breakdown...
Eligibility Criteria
Inclusion
- Motor and sensory complete spinal cord injury above the level T12.
- No open skin problems or hospitalizations during the three months prior to entrance into the study.
Exclusion
- Age less than 18 years.
- Less than two years post-injury or loss of independent walking ability.
- More than three urinary tract infections in the previous year.
- Significant active systemic disease, e.g. heart disease, renal failure, diabetes.
- Abnormal nutritional status based on albumin and total protein levels at recruitment (3.0 for albumin, 6.0 for total protein).
- Osteomyelitis of the pelvic region, indicated by positive pelvic inlet X-ray from routine annual urologic examination or bone scan.
- Previous surgery in the perineal region that radically alters the basic anatomy, particularly regional innervation and blood supply, e.g. amputation, hemipelvectomy.
- Extensive lower motor neuron damage to motor nerves innervating the gluteal muscles or electrical excitability of gluteal muscles with lower motor neuron innervation insufficient to produce desired level of contraction.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00262457
Start Date
April 1 2004
End Date
February 1 2008
Last Update
September 17 2013
Active Locations (1)
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1
VA Medical Center, Cleveland
Cleveland, Ohio, United States, 44106