Transcutaneous Oxygen TensionNCT02798640
Comparative Study Evaluating Performance of Celliant Fibers on Tissue Oxygenation
A study testing Celliant in people with Transcutaneous Oxygen Tension, run by Kristopher Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Transcutaneous Oxygen Tension
- What is being tested?
- Celliant
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Transcutaneous Oxygen Tension
- Being tested
- Celliant, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelliantDevice
100% Celliant garment
ControlDevice
Control Garment
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Subject wearing Celliant garment Receives: Device: Celliant |
| Control | Placebo comparator | Subject wearing non-celliant control garment Receives: Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in transcutaneous oxygen tension (tcPO2)
comparison of individual measurements taken at these time points
Measured: 0,30,60,90 minutes
Secondary outcomes (1)
Changes in local skin temperature by infrared imaging
comparison of individual measurements taken at these time points
Measured: 0,30,60,90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startSep 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcutaneous Oxygen TensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kristopher Washington
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Kristopher Washington, Hologenix, LLC
- Investigators
- Ian L Gordon, M.D., Principal investigator, University of California Medical Center Wound ClinicKristopher Washington, B.S., Study director, Hologenix, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798640
- Sponsor's protocol ID
- HC1-2
- Status last verified
- Jun 2016
- First submitted
- 9 Jun 2016
- Last updated
- 14 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02798640
- Acronym / sponsor ID
- HC1-2
- Conditions
- Transcutaneous Oxygen Tension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Kristopher WashingtonIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 14 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Device: CelliantSubject wearing Celliant garment |
| Control | Placebo comparator | Device: ControlSubject wearing non-celliant control garment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Celliant100% Celliant garment | Device | Active |
| ControlControl Garment | Device | Control |
Primary outcome
Changes in transcutaneous oxygen tension (tcPO2)
Time frame: 0,30,60,90 minutes
comparison of individual measurements taken at these time points
1 secondary outcome
Changes in local skin temperature by infrared imaging
Time frame: 0,30,60,90 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2016.
- Individual participant dataSharing planned: No
Related trials for Transcutaneous Oxygen Tension
Recruiting
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Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian L Gordon, M.D. principal investigator
University of California Medical Center Wound Clinic
Kristopher Washington, B.S. study director
Hologenix, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Celliant in people with Transcutaneous Oxygen Tension, run by Kristopher Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in transcutaneous oxygen tension (tcPO2) (time frame: 0,30,60,90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2016.