Comparative Study Evaluating Performance of Celliant Fibers on Tissue Oxygenation

A Single Center Prospective Comparative Study to Evaluate the Performance of a Upper Torso Garment Containing 100% Celliant Fibers That Emits Far Infrared (FIR) From Ceramic Particles Contained Within the Fibers in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Transcutaneous Oxygen Tension
• Intervention / Treatment: Device: Celliant; Device: Control

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90403
      • Hologenix, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Active; Subject wearing Celliant garment	Device: Celliant; 100% Celliant garment
PLACEBO_COMPARATOR: Control; Subject wearing non-celliant control garment	Device: Control; Control Garment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in transcutaneous oxygen tension (tcPO2)	comparison of individual measurements taken at these time points	0,30,60,90 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in local skin temperature by infrared imaging	comparison of individual measurements taken at these time points	0,30,60,90 minutes

Collaborators and Investigators

• Sponsor: Kristopher Washington
• Investigators: Principal Investigator: Ian L Gordon, M.D., University of California Medical Center Wound Clinic; Study Director: Kristopher Washington, B.S., Hologenix, LLC

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (ACTUAL): January 1, 2014
• Study Completion (ACTUAL): January 1, 2014

Study Registration Dates

• First Submitted: June 9, 2016
• First Submitted That Met QC Criteria: June 13, 2016
• First Posted (ESTIMATE): June 14, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): June 14, 2016
• Last Update Submitted That Met QC Criteria: June 13, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: HC1-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Informed Consent Form
2. Clinical Investigation plan
3. Clinical Study Report