BIONs, for Improved Tissue Health and Pressure Sore Prevention

Withdrawn before enrolling · Not applicable

Conditions studied: Pressure Ulcers, Spinal Cord Injury

In brief

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 patients.

Key facts

Study ID

NCT00262457

Run by

US Department of Veterans Affairs

People needed

0

Starts

2004-04-01

Expected to finish

2008-02-01

Last updated by the study team

2013-09-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• VA Medical Center, Cleveland — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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