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Tissue Perfusion and Blood Flow Monitoring Technology (WoundImager)

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
CW Optics, Inc.
ClinicalTrials.gov Identifier:
NCT01139567
First received: May 27, 2010
Last updated: June 28, 2013
Last verified: June 2013
  Purpose

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
Wounds and Injuries

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Tissue Perfusion and Blood Flow Monitoring Technology

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 56
Study Start Date: June 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
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 the Chippenham and Johnston-Willis Medical Center (CJW) 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:

    • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01139567

Locations
United States, Virginia
Chippenham and Johnston-Willis Medical Center
Richmond, Virginia, United States, 23225
Sponsors and Collaborators
CW Optics, Inc.
  More Information

No publications provided

Responsible Party: CW Optics, Inc.
ClinicalTrials.gov Identifier: NCT01139567     History of Changes
Other Study ID Numbers: WoundImager-2010-01, 5R44HL059807-06
Study First Received: May 27, 2010
Last Updated: June 28, 2013
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 November 27, 2014