Comparative Study Evaluating Performance of Celliant Fibers on Tissue Oxygenation

K

Kristopher Washington

Status

Completed

Conditions

Transcutaneous Oxygen Tension

Treatments

Device: Control
Device: Celliant

Study type

Interventional

Funder types

Industry

Identifiers

NCT02798640
HC1-2

Details and patient eligibility

About

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.

Full 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.

Enrollment

153 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

153 participants in 2 patient groups, including a placebo group

Active
Active Comparator group
Description:
Subject wearing Celliant garment
Treatment:
Device: Celliant
Control
Placebo Comparator group
Description:
Subject wearing non-celliant control garment
Treatment:
Device: Control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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