Laser Speckle Imaging for Wound Perfusion Monitoring (WoundImager)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01675583
Recruitment Status : Completed
First Posted : August 30, 2012
Last Update Posted : July 2, 2013
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
CW Optics, Inc.

Brief Summary:
The purpose of this study is to investigate the efficacy of an optical device designed and developed to quantitatively monitor blood flow velocity of wound sites. It is hypothesized 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 Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Laser Speckle Imaging for Wound Perfusion Monitoring (WoundImager)
Study Start Date : August 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Blood flow velocity measurements [ Time Frame: 5 months ]
    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.

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
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 Winchester Medical Center 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:

    • Necrotizing fasciitis
    • Compromised/failed skin grafts/flaps
    • Chronic refractory osteomyelitis
    • Soft tissue radiation necrosis
    • Diabetic wounds, lower extremity
    • Acute peripheral arterial insufficiency
    • Crush injury
    • Venous leg disease
    • Pressure ulcer
    • Other chronic, non-healing wounds
  • Subjects must have signed the Informed Consent Forms.

Exclusion Criteria

  • 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.

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 identifier (NCT number): NCT01675583

United States, Virginia
Winchester Medical Center
Winchester, Virginia, United States, 22601
Sponsors and Collaborators
CW Optics, Inc.
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)

Responsible Party: CW Optics, Inc. Identifier: NCT01675583     History of Changes
Other Study ID Numbers: WoundImager-2012-01
5R44HL059807-06 ( U.S. NIH Grant/Contract )
First Posted: August 30, 2012    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