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
1 other identifier
interventional
153
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 9, 2016
CompletedFirst Posted
Study publicly available on registry
June 14, 2016
CompletedJune 14, 2016
June 1, 2016
4 months
June 9, 2016
June 13, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in transcutaneous oxygen tension (tcPO2)
comparison of individual measurements taken at these time points
0,30,60,90 minutes
Secondary Outcomes (1)
Changes in local skin temperature by infrared imaging
0,30,60,90 minutes
Study Arms (2)
Active
ACTIVE COMPARATORSubject wearing Celliant garment
Control
PLACEBO COMPARATORSubject wearing non-celliant control garment
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hologenix, LLC
Santa Monica, California, 90403, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Ian L Gordon, M.D.
University of California Medical Center Wound Clinic
- STUDY DIRECTOR
Kristopher Washington, B.S.
Hologenix, LLC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Study Coordinator
Study Record Dates
First Submitted
June 9, 2016
First Posted
June 14, 2016
Study Start
September 1, 2013
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
June 14, 2016
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will not share