Tissue Perfusion and Blood Flow Monitoring Technology (WoundImager)

June 28, 2013 updated by: CW Optics, Inc.
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23225
        • Chippenham and Johnston-Willis Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CW Optics, Inc.

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

May 27, 2010

First Submitted That Met QC Criteria

June 5, 2010

First Posted (Estimate)

June 8, 2010

Study Record Updates

Last Update Posted (Estimate)

July 2, 2013

Last Update Submitted That Met QC Criteria

June 28, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WoundImager-2010-01
  • 5R44HL059807-06 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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