Wounds and InjuriesWoundImagerNCT01139567
Tissue Perfusion and Blood Flow Monitoring Technology
An observational study of Wounds and Injuries, run by CW Optics, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Wounds and Injuries
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Chippenham and Johnston-Willis Medical Center
Richmond, Virginia, 23225
About this study
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.
- Conditions
- Wounds and Injuries
- Keywords
- Diabetic Wounds, Hyperbaric Oxygen, Laser Speckle Imaging, Hyperbaric Oxygenation
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CW Optics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01139567
- Sponsor's protocol ID
- WoundImager-2010-01
- Other IDs
- 5R44HL059807-06
- Acronym
- WoundImager
- Status last verified
- Jun 2013
- First submitted
- 27 May 2010
- Last updated
- 2 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Perfusion and Blood Flow Monitoring Technology
- ClinicalTrials.gov ID
- NCT01139567
- Acronym / sponsor ID
- WoundImager / WoundImager-2010-01
- Conditions
- Wounds and Injuries
- Keywords
- Diabetic Wounds, Hyperbaric Oxygen, Laser Speckle Imaging, Hyperbaric Oxygenation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- CW Optics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 8 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Subjects age 21 or older with the following types of wounds and who are able to comply with the study requirements:
- Subjects must have signed the Informed Consent Forms.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wounds and Injuries, run by CW Optics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2013.