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Muscle Oxygenation and Skin Pigmentation

Correlation Between Muscle Oxygenation and Skin Pigmentation

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00747162
Enrollment
0
Registered
2008-09-04
Start date
2008-08-31
Completion date
2009-02-28
Last updated
2013-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Oxygenation, Skin Pigmentation

Keywords

Compartment Syndrome, Muscle Oxygenation, Skin Pigmentation

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.

Interventions

DEVICEMeasure of muscle oxygenation

The investigators will use an INVOS oxymeter for muscle oxygenation measure.

DEVICESkin pigmentation determination

The investigators will use a DermaSpectrometer to get a reading from subjects' skin color

Sponsors

Emory University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Measure from The INVOS cerebral oximeter and DermaSpectrometer1 day

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026