Muscle OxygenationPhase 4NCT00747162
Muscle Oxygenation and Skin Pigmentation
A Phase 4 study testing Measure of muscle oxygenation and Skin pigmentation determination in people with Muscle Oxygenation and Skin Pigmentation, run by Emory University at 1 site in United States.
Trial summary
The investigators plan to enroll 500 consecutive Subjects at a major trauma center for this study. For each patient, the body mass index (BMI), age, sex, diastolic pressure and mean arterial pressure (MAP) at time of measurements. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Muscle Oxygenation, Skin Pigmentation
- What is being tested?
- Measure of muscle oxygenation and Skin pigmentation determination
- 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
- Aug 2008to Feb 2009
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female between the ages of 18 and 75 years old
- Subjects that have no lower extremity injuries.
- Subject who are classified as being either light or dark skin pigmentation.
- Subjects willing to participate in the study.
Who cannot join
- Patients with previous injury to either lower extremity
- Patients with previously diagnosed vascular disease or insufficiency
- Patients with pulmonary insufficiency or severe pulmonary injury
- Patients not willing to consent to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Muscle Oxygenation and Skin Pigmentation
The investigators plan to enroll 500 consecutive Subjects at a major trauma center for this study. For each patient, the body mass index (BMI), age, sex, diastolic pressure and mean arterial pressure (MAP) at time of measurements. Additional information including diseases such as diabetes and vascular disorders will be recorded. Social demographics including alcohol and tobacco use will be recorded. This is important as alcohol and tobacco use could also contribute to cardiovascular diseases. The skin pigmentation of each subject will be recorded. Two different methods will be used for this measurement. Each patient will be graded on a six point scale as described by Young (Young, 1997). Additionally, each subject will have their skin measured using a reflectance colorimeter. The colorimeter, DermaSpectrometer II (cyberDerm, Broomall, PA) uses visible light to measure the amount of light reflected off the skin. By measuring the light reflectance, the skin pigmentation can be measure (Clarys, 2000). Muscle oxygenation will be measured using a continuous dual wavelength near infrared spectrometer. Using the different absorption characteristics of deoxyhemoglobin and oxyhemoglobin, the concentration of oxyhemoglobin in the muscle at an approximate depth of 2.5 cm is determined. The INVOS cerebral oximeter (Somanetics, Troy, MI) will be used for all measurements.
- Conditions
- Muscle Oxygenation, Skin Pigmentation
- Being tested
- Measure of muscle oxygenation, Skin pigmentation determination
- Keywords
- Compartment Syndrome, Muscle Oxygenation, Skin Pigmentation
- Medical subject headings
- Pigmentation Disorders, Compartment Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure of muscle oxygenationDevice
The investigators will use an INVOS oxymeter for muscle oxygenation measure.
Skin pigmentation determinationDevice
The investigators will use a DermaSpectrometer to get a reading from subjects' skin color
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | We will use The INVOS cerebral oximeter to determine oxygen content in the healthy muscle. In addition, we will use a the DermaSpectrometer to determine if there are differences in our readings according to skin color. Receives: Device: Measure of muscle oxygenation; Device: Skin pigmentation determination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure from The INVOS cerebral oximeter and DermaSpectrometer
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionJan 2009
- Study completionFeb 2009
Why it stopped: incorporated into other study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle OxygenationStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Moore, Emory University
- Investigators
- Thomas J. Moore, MD, Principal investigator, Emory University, Department of Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747162
- Sponsor's protocol ID
- IRB00009004
- Status last verified
- Nov 2013
- First submitted
- 27 Aug 2008
- Last updated
- 27 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Muscle Oxygenation and Skin Pigmentation
- ClinicalTrials.gov ID
- NCT00747162
- Acronym / sponsor ID
- IRB00009004
- Conditions
- Muscle Oxygenation, Skin Pigmentation
- Keywords
- Compartment Syndrome, Muscle Oxygenation, Skin Pigmentation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: incorporated into other study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 4 Sep 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.
The investigators plan to enroll 500 consecutive Subjects at a major trauma center for this study. For each patient, the body mass index (BMI), age, sex, diastolic pressure and mean arterial pressure (MAP) at time of measurements. Additional information including diseases such as diabetes and vascular disorders will be recorded. Social demographics including alcohol and tobacco use will be recorded. This is important as alcohol and tobacco use could also contribute to cardiovascular diseases. The skin pigmentation of each subject will be recorded. Two different methods will be used for this measurement. Each patient will be graded on a six point scale as described by Young (Young, 1997). Additionally, each subject will have their skin measured using a reflectance colorimeter. The colorimeter, DermaSpectrometer II (cyberDerm, Broomall, PA) uses visible light to measure the amount of light reflected off the skin. By measuring the light reflectance, the skin pigmentation can be measure (Clarys, 2000). Muscle oxygenation will be measured using a continuous dual wavelength near infrared spectrometer. Using the different absorption characteristics of deoxyhemoglobin and oxyhemoglobin, the concentration of oxyhemoglobin in the muscle at an approximate depth of 2.5 cm is determined. The INVOS cerebral oximeter (Somanetics, Troy, MI) will be used for all measurements.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Measure of muscle oxygenation, Device: Skin pigmentation determinationWe will use The INVOS cerebral oximeter to determine oxygen content in the healthy muscle. In addition, we will use a the DermaSpectrometer to determine if there are differences in our readings according to skin color. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or Female between the ages of 18 and 75 years old
- Subjects that have no lower extremity injuries.
- Subject who are classified as being either light or dark skin pigmentation.
- Subjects willing to participate in the study.
Key exclusion criteria (4 listed)
- Patients with previous injury to either lower extremity
- Patients with previously diagnosed vascular disease or insufficiency
- Patients with pulmonary insufficiency or severe pulmonary injury
- Patients not willing to consent to participate
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 |
|---|---|---|
| Measure of muscle oxygenationThe investigators will use an INVOS oxymeter for muscle oxygenation measure. | Device | 1 |
| Skin pigmentation determinationThe investigators will use a DermaSpectrometer to get a reading from subjects' skin color | Device | 1 |
Primary outcome
Measure from The INVOS cerebral oximeter and DermaSpectrometer
Time frame: 1 day
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 27 Nov 2013.
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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.
Thomas J. Moore, MD principal investigator
Emory University, Department of Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Measure of muscle oxygenation and Skin pigmentation determination in people with Muscle Oxygenation and Skin Pigmentation, run by Emory University 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 4 inclusion and 4 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 27 Nov 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 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?
Measure from The INVOS cerebral oximeter and DermaSpectrometer (time frame: 1 day). 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 27 Nov 2013.