Comparative Study Evaluating Performance of Celliant Fibers on Tissue Oxygenation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-01-31

Brief Summary

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The study will evaluate changes in transcutaneous oxygen tension (tcPO2,), and the inferred change in local cutaneous blood flow, in healthy subjects wearing a control and a 100% Celliant® fiber upper torso garment.

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Detailed Description

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Adequate blood supply is necessary for many physiologic processes. However, there are few valid, reproducible, non-invasive methods with which to assess it. One such measure is transcutaneous partial pressure of oxygen (tcPO2). This measurement is a non-invasive method of measuring oxygen tension at the skin surface; represents the amount of oxygen diffusing outward across the skin; and can be used as a surrogate for arterial perfusion. This method is reproducible with clinically acceptable intrasubject variability; is used for a variety of conditions, including peripheral vascular disease evaluation, predicting the outcome of patients requiring amputation and survival of skin grafts; and correlates well to angiography and increases in blood flow rates. However, tcPO2 is affected by many variables, including oxygen concentration in inspired air, lung function and hemoglobin saturation, as well as local factors, such as skin thickness, sympathetic tone, the presence of inflammation, capillary formation and skin oxygen consumption.

Conditions

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Transcutaneous Oxygen Tension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Active

Subject wearing Celliant garment

Group Type ACTIVE_COMPARATOR

Celliant

Intervention Type DEVICE

100% Celliant garment

Control

Subject wearing non-celliant control garment

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DEVICE

Control Garment

Interventions

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Celliant

100% Celliant garment

Intervention Type DEVICE

Control

Control Garment

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects greater than or equal to18 years of age
* Men and women between the ages of 18 and 60 years
* Able to understand and consent to the study
* Able to follow directions of the Study Coordinators and/or the Principal Investigator
* Able to complete the study
* Male or female subjects of any ethnic origin such that the balance across ages and among population groups is reflective of the site population

Exclusion Criteria

* Active smokers
* No history of cardiovascular disease
* No history of peripheral vascular disease
* Engaged in recreational drug use for the six months prior to the start of the study
* Eaten within two (2) hours of the study
* Consumed caffeine within four (4) hours prior to the study
* Consumed alcohol with forty-eight (48) hours prior to the study
* Subjects with any unstable medical or psychiatric problem
* Subjects who are pregnant or nursing mothers
* Subjects who are currently taking part in another clinical study or have taken part in a drug or device study, in the past month.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes