Tissue Perfusion and Blood Flow Monitoring Technology

CW Optics, Inc.56 enrolled

Overview

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.

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: * 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.

Locations (1)

Chippenham and Johnston-Willis Medical Center

Richmond, Virginia, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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