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OpenTrials
Completed

NCT Number: NCT01139567

Tissue Perfusion and Blood Flow Monitoring Technology

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.

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Key information

Conditions

Wounds and Injuries

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chippenham and Johnston-Willis Medical Center

Richmond, Virginia, 23225, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

CW Optics, Inc.

Industry

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Acronym: WoundImager

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jun 8, 2010
Registry last updated
Jul 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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