Pressure Ulcers Clinical Trial
Official title:
Implanted Gluteal Stimulation System for Pressure Sore Prevention
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 of veterans with reduced mobility in order to establish clinical efficacy of a 2-channel bilateral gluteal stimulation system. A two-arm crossover study of wheelchair users with complete SCI will be carried out. All study participants will receive a fully implanted system incorporating implanted IM electrodes and a Micropulse I IPG stimulator (NDI Medical). Group assignments will be determined at enrollment using a modified randomization scheme. A total of 10 subjects will be recruited to the pilot clinical trial.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | August 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Motor and sensory complete SCI higher than the level T12. Exclusion Criteria: 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: 1. Age less than 18 years. 2. Less than two years post-injury or loss of independent walking ability. 3. More than three urinary tract infections in the previous year. 4. Significant active systemic disease, e.g. heart disease, renal failure, compromised renal function, diabetes. 5. Abnormal nutritional status based on albumin and total protein levels at recruitment (3.0 for albumin, 6.0 for total protein). 6. Osteomyelitis of the pelvic regional, indicated by positive pelvic inlet x-ray from routine annual urologic examination or bone scan. 7. Previous surgery in the perineal region that radically alters the basic anatomy, particularly regional innervation and blood supply., e.g., amputation, hemipelvectomy. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Louis Stokes VA Medical Center, Cleveland, OH | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcomes measures will be changes in tissue health variables and user satisfaction | baseline, 4 weeks, and six months | No | |
Secondary | Progressive changes in muscle bulk and tissue blood flow will be evaluated using CT scanning and transcutaneous oxygen measurement | baseline, 4 weeks, and six months | No | |
Secondary | Pressure distribution changes over the long-term (due to muscle changes) and over the short-term (due to muscle contractions) will be assessed by interface pressure measurement. | baseline, 4 weeks, and six months | No |
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