WoundsHBOTNCT00768027
Outcome Assessment in Patients Treated With Hyperbaric Oxygen Using OxyVu Tissue Oxygenation Monitoring System
An observational study of Wounds, run by HyperMed at 3 sites in United States.
Trial summary
The objective is to define patient eligibility for hyperbaric oxygen therapy and to evaluate wound healing progression using a new hyperspectral imaging technology. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Wounds
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2008to Nov 2010
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 18 to 85 years of age, males and females, and with and without diabetes and untreatable peripheral vascular disease.
Who may be able to join
- 18 - 85 years of age
- Patients with wounds that meet the criteria for hyperbaric oxygen therapy (e.g. problem wound, diabetic foot ulcer, necrotizing soft tissue infections)
- Compromised Flap or Grafts.
Who cannot join
- Patients with poor cardiac output (EF < 20%)
- Patients with severe obstructive pulmonary disease who don't qualify for HBOT
- Patients with untreated asthma who don't qualify for HBOT
- Patients utilizing supplemental oxygen and those on ventilators
- Patients on life support medications (pressors)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Long Beach Memorial Medical Center
Long Beach, California, 90822
Long Beach VA Medical Center
Long Beach, California, 90822
Hyperbaric & Wound Care Associates
Milwaukee, Wisconsin, 53215
About this study
The objective is to define patient eligibility for hyperbaric oxygen therapy and to evaluate wound healing progression using a new hyperspectral imaging technology.
Read the detailed description
The purpose of this clinical study is to define patient eligibility for hyperbaric oxygen therapy (HBOT) and to evaluate wound healing progression during HBOT using a new hyperspectral imaging technology (OxyVu).
- Conditions
- Wounds
- Keywords
- hyperspectral imaging, tissue oxygenation, wounds, wound healing, prevention, hyperbaric
- Medical subject headings
- Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
OxyVu measurements will be compared to transcutaneous oxygen measurements pre and post HBOT
Measured: Days 1, 7, 14, 21, 4wks, and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2008 (estimated)
- Study startAug 2008
- Primary completionNov 2010 (estimated)
- Study completionNov 2010 (estimated)
Why it stopped: Seeking additional funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for WoundsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HyperMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hyperbaric and Wound Care Associates, VA Long Beach Healthcare System, Long Beach Memorial Medical Center
- Investigators
- Jeffrey Niezgoda, MD, Principal investigator, Hyperbaric & Wound Care AssociatesIan L Gordon, MD PhD, Principal investigator, VA Long Beach Healthcare SystemMichael B Strauss, MD, Principal investigator, Long Beach Memorial Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00768027
- Sponsor's protocol ID
- 2008-012
- Acronym
- HBOT
- Status last verified
- Jun 2009
- First submitted
- 6 Oct 2008
- Last updated
- 4 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Mathieu D. Role of hyperbaric oxygen therapy in the management of lower extremity wounds. Int J Low Extrem Wounds. 2006 Dec;5(4):233-5. doi: 10.1177/1534734606294450. No abstract available.
PubMed 17088598Niinikoski JH. Clinical hyperbaric oxygen therapy, wound perfusion, and transcutaneous oximetry. World J Surg. 2004 Mar;28(3):307-11. doi: 10.1007/s00268-003-7401-1. Epub 2004 Feb 17.
PubMed 14961187Niinikoski J. Hyperbaric oxygen therapy of diabetic foot ulcers, transcutaneous oxymetry in clinical decision making. Wound Repair Regen. 2003 Nov-Dec;11(6):458-61. doi: 10.1046/j.1524-475x.2003.11610.x.
PubMed 14617286Fife CE, Buyukcakir C, Otto GH, Sheffield PJ, Warriner RA, Love TL, Mader J. The predictive value of transcutaneous oxygen tension measurement in diabetic lower extremity ulcers treated with hyperbaric oxygen therapy: a retrospective analysis of 1,144 patients. Wound Repair Regen. 2002 Jul-Aug;10(4):198-207. doi: 10.1046/j.1524-475x.2002.10402.x.
PubMed 12191001Fife CE, Buyukcakir C, Otto G, Sheffield P, Love T, Warriner R 3rd. Factors influencing the outcome of lower-extremity diabetic ulcers treated with hyperbaric oxygen therapy. Wound Repair Regen. 2007 May-Jun;15(3):322-31. doi: 10.1111/j.1524-475X.2007.00234.x.
PubMed 17537119Niezgoda JA, Mewissen M. The management of lower extremity wounds complicated by acute arterial insufficiency and ischemia. Ostomy Wound Manage. 2004 May;50(5A Suppl):1-11; quiz 12.
PubMed 15366447Deerochanawong C, Home PD, Alberti KG. A survey of lower limb amputation in diabetic patients. Diabet Med. 1992 Dec;9(10):942-6. doi: 10.1111/j.1464-5491.1992.tb01736.x.
PubMed 1478041Frykberg RG. Guidelines for diabetic foot care. Foot Ankle Int. 2000 Jul;21(7):616. doi: 10.1177/107110070002100716. No abstract available.
PubMed 10919631
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Assessment in Patients Treated With Hyperbaric Oxygen Using OxyVu Tissue Oxygenation Monitoring System
- ClinicalTrials.gov ID
- NCT00768027
- Acronym / sponsor ID
- HBOT / 2008-012
- Conditions
- Wounds
- Keywords
- hyperspectral imaging, tissue oxygenation, wounds, wound healing, prevention, hyperbaric
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Seeking additional funds
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- HyperMedIndustry (pharma, biotech, devices)
- Collaborators
- Hyperbaric and Wound Care Associates, VA Long Beach Healthcare System, Long Beach Memorial Medical Center
- Study start
- Aug 2008
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Nov 2010 (estimated)
- First posted
- 7 Oct 2008 (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 objective is to define patient eligibility for hyperbaric oxygen therapy and to evaluate wound healing progression using a new hyperspectral imaging technology.
Detailed description
The purpose of this clinical study is to define patient eligibility for hyperbaric oxygen therapy (HBOT) and to evaluate wound healing progression during HBOT using a new hyperspectral imaging technology (OxyVu).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18 to 85 years of age, males and females, and with and without diabetes and untreatable peripheral vascular disease.
Key inclusion criteria (3 listed)
- 18 - 85 years of age
- Patients with wounds that meet the criteria for hyperbaric oxygen therapy (e.g. problem wound, diabetic foot ulcer, necrotizing soft tissue infections)
- Compromised Flap or Grafts.
Key exclusion criteria (5 listed)
- Patients with poor cardiac output (EF < 20%)
- Patients with severe obstructive pulmonary disease who don't qualify for HBOT
- Patients with untreated asthma who don't qualify for HBOT
- Patients utilizing supplemental oxygen and those on ventilators
- Patients on life support medications (pressors)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
OxyVu measurements will be compared to transcutaneous oxygen measurements pre and post HBOT
Time frame: Days 1, 7, 14, 21, 4wks, and 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2009.
- Background: PubMed 17088598Mathieu D. Role of hyperbaric oxygen therapy in the management of lower extremity wounds. Int J Low Extrem Wounds. 2006 Dec;5(4):233-5. doi: 10.1177/1534734606294450. No abstract available.
- Background: PubMed 14961187Niinikoski JH. Clinical hyperbaric oxygen therapy, wound perfusion, and transcutaneous oximetry. World J Surg. 2004 Mar;28(3):307-11. doi: 10.1007/s00268-003-7401-1. Epub 2004 Feb 17.
- Background: PubMed 14617286Niinikoski J. Hyperbaric oxygen therapy of diabetic foot ulcers, transcutaneous oxymetry in clinical decision making. Wound Repair Regen. 2003 Nov-Dec;11(6):458-61. doi: 10.1046/j.1524-475x.2003.11610.x.
- Background: PubMed 12191001Fife CE, Buyukcakir C, Otto GH, Sheffield PJ, Warriner RA, Love TL, Mader J. The predictive value of transcutaneous oxygen tension measurement in diabetic lower extremity ulcers treated with hyperbaric oxygen therapy: a retrospective analysis of 1,144 patients. Wound Repair Regen. 2002 Jul-Aug;10(4):198-207. doi: 10.1046/j.1524-475x.2002.10402.x.
- Background: PubMed 17537119Fife CE, Buyukcakir C, Otto G, Sheffield P, Love T, Warriner R 3rd. Factors influencing the outcome of lower-extremity diabetic ulcers treated with hyperbaric oxygen therapy. Wound Repair Regen. 2007 May-Jun;15(3):322-31. doi: 10.1111/j.1524-475X.2007.00234.x.
- Background: PubMed 15366447Niezgoda JA, Mewissen M. The management of lower extremity wounds complicated by acute arterial insufficiency and ischemia. Ostomy Wound Manage. 2004 May;50(5A Suppl):1-11; quiz 12.
- Background: PubMed 1478041Deerochanawong C, Home PD, Alberti KG. A survey of lower limb amputation in diabetic patients. Diabet Med. 1992 Dec;9(10):942-6. doi: 10.1111/j.1464-5491.1992.tb01736.x.
- Background: PubMed 10919631Frykberg RG. Guidelines for diabetic foot care. Foot Ankle Int. 2000 Jul;21(7):616. doi: 10.1177/107110070002100716. No abstract available.
- Sponsor and OxyVu technology websiteLink provided by the sponsor.
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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.
Jeffrey Niezgoda, MD principal investigator
Hyperbaric & Wound Care Associates
Ian L Gordon, MD PhD principal investigator
VA Long Beach Healthcare System
Michael B Strauss, MD principal investigator
Long Beach Memorial Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wounds, run by HyperMed at 3 sites 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 3 inclusion and 5 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: paused, as of the sponsor's last update on 4 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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?
Results are not available in the source record.
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?
OxyVu measurements will be compared to transcutaneous oxygen measurements pre and post HBOT (time frame: Days 1, 7, 14, 21, 4wks, and 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00768027, which also lists 8 linked publications.
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 4 Jun 2009.