Tissue Perfusion and Blood Flow Monitoring Technology (WoundImager)
This study is currently recruiting participants.
Verified August 2012 by CW Optics, Inc.
Information provided by (Responsible Party):
CW Optics, Inc.
First received: May 27, 2010
Last updated: August 13, 2012
Last verified: August 2012
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.
||Observational Model: Case Control
Time Perspective: Retrospective
||Tissue Perfusion and Blood Flow Monitoring Technology
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
Standard Care Group
Subjects who will undergo only standard wound care management.
Hyperbaric Oxygen Therapy Group
Subjects who are selected for adjunctive hyperbaric oxygen therapy in addition to standard wound care intervention.
|Ages Eligible for Study:
||21 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Adult patients who have chronic lower extremity wounds will be recruited from the patient population at the Chippenham and Johnston-Willis Medical Center (CJW) for enrollment in the study.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01139567
|Chippenham and Johnston-Willis Medical Center
|Richmond, Virginia, United States, 23225 |
|Contact: Lisa Shawler, RN, CCRC, CIM 804-228-6732 Lisa.Shawler@HCAHealthcare.com |
|Principal Investigator: Joseph V Boykin, MD |
|Sub-Investigator: Richard G Lewis, MD |
|Sub-Investigator: Kara B Daniel, PA-C |
|Sub-Investigator: Mary Crossland, RN |
|Sub-Investigator: Jonathan N Brantley, DPM |
|Sub-Investigator: Stephen P Crossland, MD |
|Sub-Investigator: John C Deitrick, MD |
|Sub-Investigator: Gina Middlebrook, NP |
CW Optics, Inc.
No publications provided
||CW Optics, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 27, 2010
||August 13, 2012
||United States: Institutional Review Board
Keywords provided by CW Optics, Inc.:
Laser Speckle Imaging
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 19, 2013