Muscle Oxygenation and Skin Pigmentation

Skin Pigmentation Clinical Trial

Official title:

Correlation Between Muscle Oxygenation and Skin Pigmentation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00747162
• Other study ID #: IRB00009004
• Status: Withdrawn
• Phase: Phase 4
• First received: August 27, 2008
• Last updated: November 26, 2013
• Start date: August 2008
• Est. completion date: February 2009

Study information

• Verified date: November 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Muscle Oxygenation
• Skin Pigmentation

Intervention

Device:
• Measure of muscle oxygenation
The investigators will use an INVOS oxymeter for muscle oxygenation measure.
• Skin pigmentation determination
The investigators will use a DermaSpectrometer to get a reading from subjects' skin color

Locations

Country	Name	City	State
United States	Grady Healthcare System	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure from The INVOS cerebral oximeter and DermaSpectrometer		1 day	No