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Tissue Perfusion and Blood Flow Monitoring Technology (WoundImager)

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ClinicalTrials.gov Identifier: NCT01139567
Recruitment Status : Completed
First Posted : June 8, 2010
Last Update Posted : July 2, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to investigate the safety and efficacy of an optical device designed and developed to quantitatively monitor blood flow velocity of wound sites. The hypothesis is that the blood flow velocity of the wound site will provide critical information on the efficacy of hyperbaric oxygen therapy.

Condition or disease
Wounds and Injuries

Study Design

Study Type : Observational
Estimated Enrollment : 56 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Tissue Perfusion and Blood Flow Monitoring Technology
Study Start Date : June 2010
Primary Completion Date : April 2013
Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Standard Care Group
Subjects who will undergo only standard wound care management.
Hyperbaric Oxygen Therapy Group
Subjects who are selected for adjunctive hyperbaric oxygen therapy in addition to standard wound care intervention.

Outcome Measures

Primary Outcome Measures :
  1. Effectiveness of blood flow velocity measurements of wound sites to assess tissue viability with a novel optical device. Comparison between the responses of patients treated with hyperbaric oxygen therapy and those treated by other means will be made. [ Time Frame: 2 years ]

Eligibility Criteria

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients who have chronic lower extremity wounds will be recruited from the patient population at the Chippenham and Johnston-Willis Medical Center (CJW) for enrollment in the study.

Inclusion Criteria

  • Subjects age 21 or older with the following types of wounds and who are able to comply with the study requirements:

    • neuropathic diabetic foot ulcer
    • soft tissue radiation necrosis
    • crush injury
    • compromised/failed skin grafts and flaps
  • Subjects must have signed the Informed Consent Forms.

Exclusion Criteria

  • Subjects who are not candidates for HBO therapy for any reason, including but not limited to: untreated pneumothorax, uncontrolled congestive heart failure, seizure disorder, neoplastic tumors, claustrophobia (for those in the HBO Group).
  • Female subjects who are pregnant or nursing.
  • Anyone who is unable to give written informed consent.
  • Subjects with end-stage renal disease or who require peritoneal or hemodialysis.
  • Subjects with current malignancies.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01139567

United States, Virginia
Chippenham and Johnston-Willis Medical Center
Richmond, Virginia, United States, 23225
Sponsors and Collaborators
CW Optics, Inc.
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
More Information

Responsible Party: CW Optics, Inc.
ClinicalTrials.gov Identifier: NCT01139567     History of Changes
Other Study ID Numbers: WoundImager-2010-01
5R44HL059807-06 ( U.S. NIH Grant/Contract )
First Posted: June 8, 2010    Key Record Dates
Last Update Posted: July 2, 2013
Last Verified: June 2013

Keywords provided by CW Optics, Inc.:
Diabetic Wounds
Hyperbaric Oxygen
Laser Speckle Imaging
Hyperbaric Oxygenation

Additional relevant MeSH terms:
Wounds and Injuries