Implanted Gluteal Stimulation System for Pressure Sore Prevention

NCT00623948 | Withdrawn

• 1 other identifier: B4664-R
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Pressure Ulcers

Keywords

Pressure ulcers; Electrical Stimulation; Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• The primary outcomes measures will be changes in tissue health variables and user satisfaction

  baseline, 4 weeks, and six months

Secondary Outcomes (2)

• 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

• 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

Study Arms (1)

Arm 1

OTHER

Device: A fully implanted gluteal stimulation (GSTIM) system

Interventions

A fully implanted gluteal stimulation (GSTIM) system DEVICE

A fully implanted gluteal stimulation system

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

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, 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.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Pressure Ulcer; Spinal Cord Injuries

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Kath M. Bogie, PhD

  Louis Stokes VA Medical Center, Cleveland, OH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2008
• First Posted: February 26, 2008
• Study Start: September 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: May 22, 2015

Record last verified: 2015-05

Locations

US (1)