Status:
WITHDRAWN
Implanted Gluteal Stimulation System for Pressure Sore Prevention
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Pressure Ulcers
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This project will evaluate the feasibility of using a fully implanted gluteal stimulation system for the prevention of Pressure ulcers. The specific goal of this study will be a pilot clinical trial o...
Detailed Description
Within the scope of the study the aims will be to: (1. Develop the pre-implantation assessment protocol utilizing targeted CT to locate optimal gluteal motor points bilaterally.) CT assessment of the ...
Eligibility Criteria
Inclusion
- Motor and sensory complete SCI higher than the level T12.
Exclusion
- Eligible subjects will have had no open skin problems or hospitalizations during the three months prior to entrance into the study. Additional exclusion criteria relating to clinical factors and suitability include:
- 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, compromised renal function, 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 regional, 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.
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00623948
Start Date
September 1 2012
End Date
August 1 2014
Last Update
May 22 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States, 44106