Clincosm LogoSign in Get a demo

WoundImager: Tissue Perfusion and Blood Flow Monitoring Technology

Sponsor
CW Optics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01139567
Collaborator
National Institutes of Health (NIH) (NIH), National Heart, Lung, and Blood Institute (NHLBI) (NIH)
56
Enrollment
1
Location
34
Duration (Months)
1.6
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    56 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Tissue Perfusion and Blood Flow Monitoring Technology
    Study Start Date :
    Jun 1, 2010
    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. 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. [2 years]

    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:

    • 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

    Locations

    Site City State Country Postal Code
    1 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)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CW Optics, Inc.
    ClinicalTrials.gov Identifier:
    NCT01139567
    Other Study ID Numbers:
    • WoundImager-2010-01
    • 5R44HL059807-06
    First Posted:
    Jun 8, 2010
    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