Status:
COMPLETED
Tissue Perfusion and Blood Flow Monitoring Technology
Lead Sponsor:
CW Optics, Inc.
Collaborating Sponsors:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Wounds and Injuries
Eligibility:
All Genders
21+ years
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2013
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01139567
Start Date
June 1 2010
End Date
April 1 2013
Last Update
July 2 2013
Active Locations (1)
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1
Chippenham and Johnston-Willis Medical Center
Richmond, Virginia, United States, 23225