Laser Speckle Imaging for Wound Perfusion Monitoring (WoundImager)

Wounds and Injuries Clinical Trial

Official title:

Laser Speckle Imaging for Wound Perfusion Monitoring (WoundImager)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01675583
• Other study ID #: WoundImager-2012-01
• Secondary ID: 5R44HL059807-06
• Status: Completed
• Phase: N/A
• First received: August 28, 2012
• Last updated: June 28, 2013
• Start date: August 2012
• Est. completion date: April 2013

Study information

• Verified date: June 2013
• Source: CW Optics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Wounds and Injuries

Locations

Country	Name	City	State
United States	Winchester Medical Center	Winchester	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
CW Optics, Inc.	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No