Laser Speckle Imaging for Wound Perfusion Monitoring (WoundImager)

CW Optics, Inc.20 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Wounds and Injuries

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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.

Locations (1)

Winchester Medical Center

Winchester, Virginia, United States

Outcomes

Primary Outcomes

Blood flow velocity measurements

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: 5 months

Data from ClinicalTrials.gov

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