Laser Speckle Imaging for Wound Perfusion Monitoring (WoundImager)
2 other identifiers
observational
20
1 country
1
Brief Summary
The purpose of this study is to investigate the efficacy of an optical device designed and developed to quantitatively monitor blood flow velocity of wound sites. It is hypothesized that the blood flow velocity of the wound site will provide critical information on the efficacy of hyperbaric oxygen therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2012
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 28, 2012
CompletedFirst Posted
Study publicly available on registry
August 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedJuly 2, 2013
June 1, 2013
8 months
August 28, 2012
June 28, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood flow velocity measurements
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.
5 months
Study Arms (2)
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.
Eligibility Criteria
Adult patients who have chronic lower extremity wounds will be recruited from the patient population at Winchester Medical Center for enrollment in the study.
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:
- Necrotizing fasciitis
- Compromised/failed skin grafts/flaps
- Chronic refractory osteomyelitis
- Soft tissue radiation necrosis
- Diabetic wounds, lower extremity
- Acute peripheral arterial insufficiency
- Crush injury
- Venous leg disease
- Pressure ulcer
- Other chronic, non-healing wounds
- Subjects must have signed the Informed Consent Forms.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CW Optics, Inc.lead
- National Institutes of Health (NIH)collaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (1)
Winchester Medical Center
Winchester, Virginia, 22601, United States
MeSH Terms
Conditions
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2012
First Posted
August 30, 2012
Study Start
August 1, 2012
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
July 2, 2013
Record last verified: 2013-06