Pressure UlcersNCT00262457
BIONs, for Improved Tissue Health and Pressure Sore Prevention
A study testing Implanted gluteal electrical stimulation system in people with Pressure Ulcers and Spinal Cord Injury, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pressure Ulcers, Spinal Cord Injury
- What is being tested?
- Implanted gluteal electrical stimulation system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Feb 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The overall goal of this project was to implement the use of a gluteal stimulation system incorporating BION microstimulators for pressure ulcer prevention in patients at high risk of tissue breakdown as a standard clinical practice.The specific goal of this study is to establish the feasibility of a system incorporating BION microstimulators for long term use. This will be achieved by a two phase study. The initial phase of the study will employ biomechanical testing and in-vitro evaluations to address issues of safety and system design. The specific tasks to be achieved in the initial phase are:
Biomechanical testing to characterize the device response to traumatic loading conditions.
In-vitro testing to determine the optimal configuration of the system, specifically the effects of BION orientation and placement relative to the coil.
A series of cadaveric studies to determine guidelines for the BION implantation procedure required to achieve optimal function of the gluteal stimulation system.
The second phase of the study will be a pilot clinical trail of veterans with reduced mobility in order to establish clinical utility. A two-arm crossover study of wheelchair users will be carried out. A total of 10 subjects will be recruited to the study. Participants will be randomly assigned to Group A or Group B. All subjects will receive BION microstimulators implanted bilaterally adjacent to the motor point of the gluteus maximus. Two stimulation regimes will be employed; conditioning stimulation will be applied at night to increase muscle strength and fatigue resistance of the stimulated muscles while dynamic stimulation will be employed during the day in order to facilitate regular weight shifting, thus varying seated posture and pressure distributions at the seating interface. Subjects in Group A will start using dynamic and conditioning stimulation concurrently for 6 months following implantation. They will then cease using all stimulation for a further 6 months of participation in the study. Group B will not activate their stimulation systems for 6 months following implantation. They will then commence using dynamic and conditioning stimulation for 6 months.
All subjects will be followed for a 12 month period following implantation. Tissue health assessments will be carried out at three month intervals throughout their participation in the study. Progressive changes in gluteal tissue health will assessed by:
- Transcutaneous oxygen measurement to measure tissue blood flow.
- Interface pressure measurement to determine pressure distribution changes over the long-term (due to muscle changes) and over the short-term (due to muscle contractions).
- Computerized tomography (CT) to measure muscle thickness. The results of this study will provide the pilot data for the development of a full-scale clinical trial of the gluteal BION system.
- Conditions
- Pressure Ulcers, Spinal Cord Injury
- Being tested
- Implanted gluteal electrical stimulation system
- Keywords
- electrical stimulation, Pressure Ulcers, Spinal Cord Injury
- Medical subject headings
- Pressure Ulcer, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implanted gluteal electrical stimulation systemDevice
Implanted electrical stimulation system incorporating BION microstimulators
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Device: Implanted gluteal electrical stimulation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of tissue health
Measured: Not feasible
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2005 (estimated)
- Study startApr 2004
- Primary completionFeb 2008
- Study completionFeb 2008
Why it stopped: It was found that the devices were not suitable for the application.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kath M. Bogie, PhD, Principal investigator, VA Medical Center-Cleveland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00262457
- Sponsor's protocol ID
- B3259-R
- Status last verified
- Sep 2013
- First submitted
- 2 Dec 2005
- Last updated
- 17 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIONs, for Improved Tissue Health and Pressure Sore Prevention
- ClinicalTrials.gov ID
- NCT00262457
- Acronym / sponsor ID
- B3259-R
- Conditions
- Pressure Ulcers, Spinal Cord Injury
- Keywords
- electrical stimulation, Pressure Ulcers, Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: It was found that the devices were not suitable for the application.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Apr 2004
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 6 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The overall goal of this project was to implement the use of a gluteal stimulation system incorporating BION microstimulators for pressure ulcer prevention in patients at high risk of tissue breakdown as a standard clinical practice.The specific goal of this study is to establish the feasibility of a system incorporating BION microstimulators for long term use. This will be achieved by a two phase study. The initial phase of the study will employ biomechanical testing and in-vitro evaluations to address issues of safety and system design. The specific tasks to be achieved in the initial phase are:
Biomechanical testing to characterize the device response to traumatic loading conditions.
In-vitro testing to determine the optimal configuration of the system, specifically the effects of BION orientation and placement relative to the coil.
A series of cadaveric studies to determine guidelines for the BION implantation procedure required to achieve optimal function of the gluteal stimulation system.
The second phase of the study will be a pilot clinical trail of veterans with reduced mobility in order to establish clinical utility. A two-arm crossover study of wheelchair users will be carried out. A total of 10 subjects will be recruited to the study. Participants will be randomly assigned to Group A or Group B. All subjects will receive BION microstimulators implanted bilaterally adjacent to the motor point of the gluteus maximus. Two stimulation regimes will be employed; conditioning stimulation will be applied at night to increase muscle strength and fatigue resistance of the stimulated muscles while dynamic stimulation will be employed during the day in order to facilitate regular weight shifting, thus varying seated posture and pressure distributions at the seating interface. Subjects in Group A will start using dynamic and conditioning stimulation concurrently for 6 months following implantation. They will then cease using all stimulation for a further 6 months of participation in the study. Group B will not activate their stimulation systems for 6 months following implantation. They will then commence using dynamic and conditioning stimulation for 6 months.
All subjects will be followed for a 12 month period following implantation. Tissue health assessments will be carried out at three month intervals throughout their participation in the study. Progressive changes in gluteal tissue health will assessed by:
- Transcutaneous oxygen measurement to measure tissue blood flow.
- Interface pressure measurement to determine pressure distribution changes over the long-term (due to muscle changes) and over the short-term (due to muscle contractions).
- Computerized tomography (CT) to measure muscle thickness. The results of this study will provide the pilot data for the development of a full-scale clinical trial of the gluteal BION system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Device: Implanted gluteal electrical stimulation system |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implanted gluteal electrical stimulation systemImplanted electrical stimulation system incorporating BION microstimulators | Device | Arm 1 |
Primary outcome
Improvement of tissue health
Time frame: Not feasible
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
- Click here for more information about this study: BIONs, for Improved Tissue Health and Pressure Sore PreventionLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kath M. Bogie, PhD principal investigator
VA Medical Center-Cleveland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implanted gluteal electrical stimulation system in people with Pressure Ulcers and Spinal Cord Injury, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of tissue health (time frame: Not feasible). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2013.