Tissue Perfusion and Blood Flow Monitoring Technology

Completed

Conditions studied: Wounds and Injuries

In brief

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.

Key facts

Study ID

NCT01139567

Run by

CW Optics, Inc.

People needed

56

Starts

2010-06-01

Expected to finish

2013-04-01

Last updated by the study team

2013-07-02

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Chippenham and Johnston-Willis Medical Center — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.