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Muscle Oxygenation and Skin Pigmentation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00747162
Recruitment Status : Withdrawn (incorporated into other study)
First Posted : September 4, 2008
Last Update Posted : November 27, 2013
Information provided by (Responsible Party):
Thomas Moore, Emory University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Muscle Oxygenation Skin Pigmentation Device: Measure of muscle oxygenation Device: Skin pigmentation determination Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Correlation Between Muscle Oxygenation and Skin Pigmentation
Study Start Date : August 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
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.
Device: Measure of muscle oxygenation
The investigators will use an INVOS oxymeter for muscle oxygenation measure.

Device: Skin pigmentation determination
The investigators will use a DermaSpectrometer to get a reading from subjects' skin color

Primary Outcome Measures :
  1. Measure from The INVOS cerebral oximeter and DermaSpectrometer [ Time Frame: 1 day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00747162

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United States, Georgia
Grady Healthcare System
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Emory University
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Principal Investigator: Thomas J. Moore, MD Emory University, Department of Orthopaedics

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Responsible Party: Thomas Moore, Assistant Professor, Emory University Identifier: NCT00747162     History of Changes
Other Study ID Numbers: IRB00009004
First Posted: September 4, 2008    Key Record Dates
Last Update Posted: November 27, 2013
Last Verified: November 2013

Keywords provided by Thomas Moore, Emory University:
Compartment Syndrome
Muscle Oxygenation
Skin Pigmentation