Wounds and Injuries
Conditions
Keywords
Diabetic Wounds, Hyperbaric Oxygen, Laser Speckle Imaging, Hyperbaric Oxygenation
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 blood flow velocity of the wound site will provide critical information on the efficacy of hyperbaric oxygen therapy.
Interventions
None listed
Sponsors
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
CW Optics, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 2 years |
Countries
United States
Outcome results
None listed