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Laser Speckle Imaging for Wound Perfusion Monitoring (WoundImager)

This study is currently recruiting participants.
Verified August 2012 by CW Optics, Inc.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
CW Optics, Inc.
ClinicalTrials.gov Identifier:
NCT01675583
First received: August 28, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose

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
Wounds and Injuries

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Laser Speckle Imaging for Wound Perfusion Monitoring (WoundImager)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by CW Optics, Inc.:

Primary Outcome Measures:
  • Blood flow velocity measurements [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: August 2012
Groups/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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01675583

Contacts
Contact: Thai Nguyen, MD 540-536-6547 tn0265@gmail.com

Locations
United States, Virginia
Winchester Medical Center Recruiting
Winchester, Virginia, United States, 22601
Contact: Jennifer Stanford, RN, MSN     540-536-8978     jstanfor@valleyhealthlink.com    
Principal Investigator: Thai Nguyen, MD            
Sub-Investigator: James E Dodd II, DPM            
Sub-Investigator: Debbie Simmons, CNA            
Sponsors and Collaborators
CW Optics, Inc.
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
  More Information

No publications provided

Responsible Party: CW Optics, Inc.
ClinicalTrials.gov Identifier: NCT01675583     History of Changes
Other Study ID Numbers: WoundImager-2012-01, 5R44HL059807-06
Study First Received: August 28, 2012
Last Updated: August 28, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on June 17, 2013