NCT00768027

Brief Summary

The objective is to define patient eligibility for hyperbaric oxygen therapy and to evaluate wound healing progression using a new hyperspectral imaging technology.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2008

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
suspended

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

August 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

June 4, 2009

Status Verified

June 1, 2009

Enrollment Period

2.3 years

First QC Date

October 6, 2008

Last Update Submit

June 2, 2009

Conditions

Wounds

Keywords

hyperspectral imagingtissue oxygenationwoundswound healingpreventionhyperbaric

Outcome Measures

Primary Outcomes (1)

  • OxyVu measurements will be compared to transcutaneous oxygen measurements pre and post HBOT

    Days 1, 7, 14, 21, 4wks, and 2 months

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

18 to 85 years of age, males and females, and with and without diabetes and untreatable peripheral vascular disease.

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Long Beach Memorial Medical Center

Long Beach, California, 90822, United States

Location

Long Beach VA Medical Center

Long Beach, California, 90822, United States

Location

Hyperbaric & Wound Care Associates

Milwaukee, Wisconsin, 53215, United States

Location

Related Publications (8)

  • 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.

    PMID: 17088598BACKGROUND

  • Niinikoski 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.

    PMID: 14961187BACKGROUND

  • Niinikoski 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.

    PMID: 14617286BACKGROUND

  • Fife 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.

    PMID: 12191001BACKGROUND

  • Fife 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.

    PMID: 17537119BACKGROUND

  • Niezgoda 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.

    PMID: 15366447BACKGROUND

  • Deerochanawong 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.

    PMID: 1478041BACKGROUND

  • Frykberg RG. Guidelines for diabetic foot care. Foot Ankle Int. 2000 Jul;21(7):616. doi: 10.1177/107110070002100716. No abstract available.

    PMID: 10919631BACKGROUND

Related Links

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Jeffrey Niezgoda, MD

    Hyperbaric & Wound Care Associates

    PRINCIPAL INVESTIGATOR

  • Ian L Gordon, MD PhD

    VA Long Beach Healthcare System

    PRINCIPAL INVESTIGATOR

  • Michael B Strauss, MD

    Long Beach Memorial Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 6, 2008

First Posted

October 7, 2008

Study Start

August 1, 2008

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

June 4, 2009

Record last verified: 2009-06

Locations

US(3)