Implanted Gluteal Stimulation System for Pressure Sore Prevention

Withdrawn before enrolling · Not applicable

Conditions studied: Pressure Ulcers

In brief

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.

Key facts

Study ID

NCT00623948

Run by

US Department of Veterans Affairs

People needed

0

Starts

2012-09-01

Expected to finish

2014-08-01

Last updated by the study team

2015-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Motor and sensory complete SCI higher than the level T12.

You may not qualify if…

• 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.

Where it is running

• Louis Stokes VA Medical Center, Cleveland, OH — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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