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Laser Speckle Imaging for Wound Perfusion Monitoring (WoundImager)

Sponsor
CW Optics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01675583
Collaborator
National Institutes of Health (NIH) (NIH), National Heart, Lung, and Blood Institute (NHLBI) (NIH)
20
Enrollment
1
Location
8
Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Laser Speckle Imaging for Wound Perfusion Monitoring (WoundImager)
    Study Start Date :
    Aug 1, 2012
    Actual Primary Completion Date :
    Apr 1, 2013
    Actual Study Completion Date :
    Apr 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    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. Blood flow velocity measurements [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CW Optics, Inc.
    ClinicalTrials.gov Identifier:
    NCT01675583
    Other Study ID Numbers:
    • WoundImager-2012-01
    • 5R44HL059807-06
    First Posted:
    Aug 30, 2012
    Last Update Posted:
    Jul 2, 2013
    Last Verified:
    Jun 1, 2013
    Keywords provided by CW Optics, Inc.
    Diabetic Wounds
    Hyperbaric Oxygen
    Laser Speckle Imaging
    Hyperbaric Oxygenation
    Additional relevant MeSH terms:
    Wounds and Injuries

    Study Results

    No Results Posted as of Jul 2, 2013