Tissue Perfusion and Blood Flow Monitoring Technology (WoundImager)
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.
Wounds and Injuries
|Study Design:||Observational Model: Case Control
Time Perspective: Retrospective
|Official Title:||Tissue Perfusion and Blood Flow Monitoring Technology|
- 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 ]
|Study Start Date:||June 2010|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01139567
|United States, Virginia|
|Chippenham and Johnston-Willis Medical Center|
|Richmond, Virginia, United States, 23225|