Pressure UlcerPhase 1NCT00628602
BION Active Seating for Pressure Ulcer Prevention
A Phase 1 study testing BION in people with Pressure Ulcer, run by University of Southern California at 1 site in United States.
Trial summary
Pressure ulcers (PUs) are a debilitating pathology resulting from pressure and shear in the soft tissues of immobilized patients. In studies to date, BION neuromuscular stimulation has been demonstrated to activate strong muscle contractions and to produce skeletal motion, with associated increases in muscle bulk… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- BION
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Dec 2008
- Phase
- Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has had a spinal cord injury and has bilateral lower limb paralysis.
- Subject cannot contract his/her gluteus muscle voluntarily.
- Subject is between 18 and 70 years old.
- Subject sits in a wheelchair for at least 5 hours per day.
- Attending physician considers the subject in general good health (other than SCI and PU wound).
- Subject has one or more PUs of Stage III or IV (according to National Pressure Ulcer Advisory Panel Staging1).
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- Subject is having a musculocutaneous (not cutaneous or fasciocutaneous) gluteal rotation flap surgery for PU treatment in which the inferior gluteal pedicle and sciatic nerve will be exposed but not damaged or sacrificed in any way (for any PU wound(s)).
- Subject is mentally capable of understanding the goals and the application of therapy.
- Subject is able to apply the therapy (with or without help) once discharged from Rancho Los Amigos.
- Subject is willing and capable of giving informed consent.
- Subject is willing and capable of traveling to testing center at the schedules.
Who cannot join
- Subject has a positive pregnancy test, is nursing / lactating, or is planning on becoming pregnant or is unwilling to not become pregnant in the next 12 months.
- Subject has an electronic implant (e.g. cardiac pacemaker, etc.).
- Subject has any condition associated with a wound healing abnormality (e.g.: connective tissue disorder, immune disorder, diabetes, clinical obesity).
- IDE application: BION Active Seating for Pressure Ulcer Prevention Page 65
- Subject is malnourished.
- The attending physician has concerns about the healing of this subject (e.g.: heavy smoking, excessive and/or poorly-managed incontinence).
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- Subject has concurrent concomitant condition affecting the buttock/pelvic area, including other pressure wound not corrected by the flap surgery.
- Subject suffers from claustrophobia or fear of MRI, or has any contraindication to MRI (e.g. metal implants, pacemaker, etc. not suited to MRI).
- Subject has damage to the inferior or superior gluteal neurovascular pedicles.
- Subject is / plans to participate in another investigational study that may affect the healing of PUs or prevent their occurrence/recurrence.
- Subject is using medications / undergoing procedures that will interfere with NMES effecting muscle contraction (e.g. treatments for spasticity and / or spasms, such as: neurotomies, tenotomies, myotomies, and rhizotomies; as well as tranquilizers and muscle relaxant / paralyzing agents such as Baclofen (Lioresal®), Dantrolene (Dantrium®) and Botulinum Toxin Type A (Botox®)).
- Subjects whose ulcer extends more than 2.25" deep to the projected surface contour of the buttock when the patient is in a prone position (measured perpendicular to the base of the PU, from the deepest point of the PU to the level of the highest point of the buttock surface, when prone)
- Subject's wheelchair and the BION system have been tested for interference of either with the other's operation, and either does not operate normally when used together, and this cannot be resolved with an available alternate wheelchair.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rancho Los Amigos National Rehabilitation Center
Downey, California, 90242
About this study
Pressure ulcers (PUs) are a debilitating pathology resulting from pressure and shear in the soft tissues of immobilized patients. In studies to date, BION neuromuscular stimulation has been demonstrated to activate strong muscle contractions and to produce skeletal motion, with associated increases in muscle bulk (hypertrophy), strength, and metabolic capacity, hence counteracting the 3 major etiological factors in PU development (immobility, soft-tissue atrophy and hypoxia).
This study intends to use neuromuscular stimulation to both shift paralyzed subjects' weight and build up gluteal muscle volume, in order to prevent recurrence of pressure ulcers. We will implant BIONs alongside the already exposed inferior gluteal and sciatic nerves in patients who are undergoing gluteal rotation flap surgery for PU reconstruction. The gluteal rotation flap is a common reconstructive technique for treating PUs by bringing healthy muscle and skin in to repair the deficient area, and to provide healthy tissue covering over bony prominences. The implanted BIONs will enable us subsequently to stimulate the gluteus maximus and hip extensor muscles. Outcome measures will include tissue health variables (measured by clinical assessment, X-Rays, MRI and Sesta-MIBI SPECT perfusion scans), pressure redistribution (measured by an array of pressure sensors), and recurrence rates over 12 months.
- Conditions
- Pressure Ulcer
- Being tested
- BION
- Keywords
- Neuromuscular stimulator, Pressure ulcer prevention
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIONDevice
30 patients operated will be randomized into 2 equal groups, a BION Therapy Group ("Rx group") and a Control Group ("Control group").
| Study group | Role | What they receive |
|---|---|---|
| Rx Group | Experimental | BION Therapy Group Receives: Device: BION |
| Control Group | Placebo comparator | control group Receives: Device: BION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical assessment of movement and shifting of weight during BAS. Record shifts in pressure distribution over seated pressure points during NMES.
Measured: upon discharge and at the 12-week, 20-week, 36-week and 52-week outpatient follow-up visits.
Secondary outcomes (1)
Clinical Examination of Braden Scale assessment,Reperfusion time,Recurrence of wounds and Body Mass Index
Measured: preoperation, upon removal of sutures, upon discharge, and at the 12-week, 20-week, 36-week and 52-week outpatient follow-up visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startNov 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerald E. Loeb, M.D., University of Southern California
- Investigators
- Lucinda Baker, Ph.D., Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628602
- Sponsor's protocol ID
- BT8
- Status last verified
- Jun 2015
- First submitted
- 25 Feb 2008
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BION Active Seating for Pressure Ulcer Prevention
- ClinicalTrials.gov ID
- NCT00628602
- Acronym / sponsor ID
- BT8
- Conditions
- Pressure Ulcer
- Keywords
- Neuromuscular stimulator, Pressure ulcer prevention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 5 Mar 2008 (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.
Pressure ulcers (PUs) are a debilitating pathology resulting from pressure and shear in the soft tissues of immobilized patients. In studies to date, BION neuromuscular stimulation has been demonstrated to activate strong muscle contractions and to produce skeletal motion, with associated increases in muscle bulk (hypertrophy), strength, and metabolic capacity, hence counteracting the 3 major etiological factors in PU development (immobility, soft-tissue atrophy and hypoxia).
This study intends to use neuromuscular stimulation to both shift paralyzed subjects' weight and build up gluteal muscle volume, in order to prevent recurrence of pressure ulcers. We will implant BIONs alongside the already exposed inferior gluteal and sciatic nerves in patients who are undergoing gluteal rotation flap surgery for PU reconstruction. The gluteal rotation flap is a common reconstructive technique for treating PUs by bringing healthy muscle and skin in to repair the deficient area, and to provide healthy tissue covering over bony prominences. The implanted BIONs will enable us subsequently to stimulate the gluteus maximus and hip extensor muscles. Outcome measures will include tissue health variables (measured by clinical assessment, X-Rays, MRI and Sesta-MIBI SPECT perfusion scans), pressure redistribution (measured by an array of pressure sensors), and recurrence rates over 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rx Group | Experimental | Device: BIONBION Therapy Group |
| Control Group | Placebo comparator | Device: BIONcontrol group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject has had a spinal cord injury and has bilateral lower limb paralysis.
- Subject cannot contract his/her gluteus muscle voluntarily.
- Subject is between 18 and 70 years old.
- Subject sits in a wheelchair for at least 5 hours per day.
- Attending physician considers the subject in general good health (other than SCI and PU wound).
Key exclusion criteria (13 listed)
- Subject has a positive pregnancy test, is nursing / lactating, or is planning on becoming pregnant or is unwilling to not become pregnant in the next 12 months.
- Subject has an electronic implant (e.g. cardiac pacemaker, etc.).
- Subject has any condition associated with a wound healing abnormality (e.g.: connective tissue disorder, immune disorder, diabetes, clinical obesity).
- IDE application: BION Active Seating for Pressure Ulcer Prevention Page 65
- Subject is malnourished.
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 |
|---|---|---|
| BION30 patients operated will be randomized into 2 equal groups, a BION Therapy Group ("Rx group") and a Control Group ("Control group"). | Device | Control Group, Rx Group |
Primary outcome
Clinical assessment of movement and shifting of weight during BAS. Record shifts in pressure distribution over seated pressure points during NMES.
Time frame: upon discharge and at the 12-week, 20-week, 36-week and 52-week outpatient follow-up visits.
1 secondary outcome
Clinical Examination of Braden Scale assessment,Reperfusion time,Recurrence of wounds and Body Mass Index
Time frame: preoperation, upon removal of sutures, upon discharge, and at the 12-week, 20-week, 36-week and 52-week outpatient follow-up visits.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
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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.
Lucinda Baker, Ph.D. principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BION in people with Pressure Ulcer, run by University of Southern California 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 11 inclusion and 13 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: finished, as of the sponsor's last update on 3 Jun 2015. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical assessment of movement and shifting of weight during BAS. Record shifts in pressure distribution over seated pressure points during NMES. (time frame: upon discharge and at the 12-week, 20-week, 36-week and 52-week outpatient follow-up visits.). 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 3 Jun 2015.