Tissue Perfusion and Blood Flow Monitoring Technology
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 5/27/2013 |
| Start Date: | June 2010 |
| Contact: | Joseph V Boykin, MD |
| Email: | joseph.boykin@hcahealthcare.com |
| Phone: | 804-254-5403 |
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.
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.
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