Tissue Perfusion and Blood Flow Monitoring Technology

Wounds and Injuries Clinical Trial

— WoundImager  

Official title:

Tissue Perfusion and Blood Flow Monitoring Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01139567
• Other study ID #: WoundImager-2010-01
• Secondary ID: 5R44HL059807-06
• Status: Completed
• Phase: N/A
• First received: May 27, 2010
• Last updated: June 28, 2013
• Start date: June 2010
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• 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:

• 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.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Wounds and Injuries

Locations

Country	Name	City	State
United States	Chippenham and Johnston-Willis Medical Center	Richmond	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	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	Yes