Wounds and InjuriesNCT02028390
Overlaying a Visual Wound Trace Onto Its Thermal Image in a Wound Clinic
A study testing Scout takes visual and thermal images of external wounds, ImageReview's visual perimeter trace of the external wound and ImageReview's External Wound Trace Overlay in people with Wounds and Injuries, run by Wound Vision at 1 site in United States.
Trial summary
The purpose of this study is to test and evaluate how well a medical imaging device that takes both visual and thermal pictures of wounds or body surface areas of interest can help collect added information about the wounds or body surface areas of interest in a wound clinic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds and Injuries
- What is being tested?
- Scout takes visual and thermal images of external wounds, ImageReview's visual perimeter trace of the external wound and ImageReview's External Wound Trace Overlay
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Mar 2016
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or greater, of either gender and of any ethnic background
- Able to tolerate position change(s) and turns for up to 10 minutes comfortably
- Have an existing external wound or body surface area of interest:
- External wound or body surface area of interest must be in separate body locations (ex: one on the right heel, one on the left heel, and the other on the sacrum)
- Have qualifying external wound or body surface area of interest:
- External wound or body surface area of interest that fits entirely within the field of view and does not wrap around a body edge
- No device or treatment will obscure the external wound or body surface area of interest
Who cannot join
- Neonatal and pediatric patients
- Pregnant women
- Cannot tolerate position changes for up to 10 minutes comfortably (per external wound site imaged)
- On therapies or treatments which cannot be safely suspended long enough to conduct an imaging session as determined by facility policy
- Have a wound dressing or medical device which cannot or should not be removed as determined by site investigator
- Have an external wound with excessive or heavy exudate that cannot be controlled during the imaging session. Excessive drainage can obscure external wound features.
Show all 12Show fewer
- If the patient has a complex external wound:
- The external wound wraps around a body edge or otherwise cannot be imaged entirely within the visual field of view.
- From visual assessment, the external wound edges are not definable and/or cannot be clearly distinguished from other conditions near external wound (E.g. breakdown or the deterioration of the surrounding body surfaces due to other conditions such as cancer or other types of ulcers makes determining the edge of the external wound impossible).
- Have not provided signed informed consent
- Non-English speaking
- Subjects in isolation
Trial locations and contacts
1 site in 1 country.
United States1 site
Integrative Center for Healing
Cincinnati, Ohio, 45242
About this study
Official title: Scout Overlay-Trace-On-Thermal Feature in a Wound Clinic Setting: A Prospective Study
The purpose of this study is to test and evaluate how well a medical imaging device that takes both visual and thermal pictures of wounds or body surface areas of interest can help collect added information about the wounds or body surface areas of interest in a wound clinic.
- Conditions
- Wounds and Injuries
- Being tested
- Scout takes visual and thermal images of external wounds, ImageReview's visual perimeter trace of the external wound, ImageReview's External Wound Trace Overlay, ImageReview's unaffected reference area selected, Adjacent tissue trace of the wound trace overlay
- Keywords
- wounds, thermal, temperature, periwound, camera, imaging
- 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.
Scout takes visual and thermal images of external woundsDevice
Also called Wound Measuring and Monitoring System/WMMS (past)
All images are taken after the wound has acclimated.
ImageReview's visual perimeter trace of the external woundDevice
Trace is drawn by the study staff using the ImageReview software.
ImageReview's External Wound Trace OverlayDevice
Study staff overlay the trace of the visual external wound's perimeter onto the corresponding thermal image of the external wound.
ImageReview's unaffected reference area selectedDevice
Study Staff select an unaffected reference area of an adjacent body surface.
Adjacent tissue trace of the wound trace overlayDevice
Study staff select an adjacent tissue trace of the wound trace overlay
| Study group | Role | What they receive |
|---|---|---|
| subjects with external wounds | Experimental | Subjects with external wounds or body surface areas of interest are imaged visually and thermally with the Scout to trace the wound's perimeter visually and measure thermal variation data as described in the primary outcomes, using the ImageReview software. Receives: Device: Scout takes visual and thermal images of external wounds; Device: ImageReview's visual perimeter trace of the external wound; Device: ImageReview's External Wound Trace Overlay; Device: ImageReview's unaffected reference area selected; Device: Adjacent tissue trace of the wound trace overlay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pixel gradient of the thermal wound surface
Pixel gradient of the thermal wound surface will be measured, with changes documented during regularly scheduled wound care visits for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years.
Measured: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
Mean pixel value of the thermal wound surface
Mean pixel value of the thermal wound surface will be measured, with changes documented during regularly scheduled wound care visits for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years.
Measured: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
Mode pixel value of the thermal wound surface
Mode pixel value of the thermal wound surface will be measured, with changes documented during regularly scheduled wound care visits at the wound clinic for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years.
Measured: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
Pixel gradient of the thermal unaffected area of body surface selected
Pixel gradient of the the thermal unaffected area of body surface selected will be measured, with changes documented during regularly scheduled wound care visits for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years.
Measured: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
Highest pixel value of the thermal wound surface
Highest pixel value of the thermal wound surface will be measured, with changes documented during regularly scheduled wound care visits for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years.
Measured: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
Lowest pixel value of the thermal wound surface
Lowest pixel value of the thermal wound surface will be measured, with changes documented during regularly scheduled wound care visits for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years.
Measured: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
Comparison of adjacent tissue trace around the wound bed's surface's relative temperature (Centigrade and Fahrenheit) to the unaffected reference area's relative temperature (Centigrade and Fahrenheit).
Comparison of adjacent tissue trace around the wound bed's surface's relative temperature (Centigrade and Fahrenheit) to the unaffected reference area's relative temperature (Centigrade and Fahrenheit), with changes documented during regularly scheduled wound care visits for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years.
Measured: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
Comparison of wound surface's relative temperature (Centigrade and Fahrenheit) to the unaffected reference area's relative temperature (Centigrade and Fahrenheit).
Comparison of wound surface's relative temperature (Centigrade and Fahrenheit) to the unaffected reference area's relative temperature (Centigrade and Fahrenheit), with changes documented during regularly scheduled wound care visits for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years.
Measured: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
Wound surface's % relative temperature above, below, or equal to the unaffected reference area's temperature
Wound surface's % relative temperature above, below, or equal to the unaffected reference area's relative temperature, with changes documented during regularly scheduled wound care visits for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years.
Measured: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
Adjacent tissue trace's surface % relative temperature above, below, or equal to the unaffected reference area's temperature
Adjacent tissue trace's surface's % relative temperature above, below, or equal to the unaffected reference area's relative temperature, with changes documented during regularly scheduled wound care visits for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years.
Measured: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2015
- Study completionMar 2016
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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wound Vision
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aletha W. Tippett, M.D., Principal investigator, Integrative Center for Healing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02028390
- Sponsor's protocol ID
- WV13CL-0008 Revision 02
- Status last verified
- Nov 2016
- First submitted
- 23 Dec 2013
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scout Overlay-Trace-On-Thermal Feature in a Wound Clinic Setting: A Prospective Study
- ClinicalTrials.gov ID
- NCT02028390
- Acronym / sponsor ID
- WV13CL-0008 Revision 02
- Conditions
- Wounds and Injuries
- Keywords
- wounds, thermal, temperature, periwound, camera, imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Wound VisionIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 7 Jan 2014 (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 test and evaluate how well a medical imaging device that takes both visual and thermal pictures of wounds or body surface areas of interest can help collect added information about the wounds or body surface areas of interest in a wound clinic.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subjects with external wounds | Experimental | Device: Scout takes visual and thermal images of external wounds, Device: ImageReview's visual perimeter trace of the external wound, Device: ImageReview's External Wound Trace Overlay, Device: ImageReview's unaffected reference area selected, Device: Adjacent tissue trace of the wound trace overlaySubjects with external wounds or body surface areas of interest are imaged visually and thermally with the Scout to trace the wound's perimeter visually and measure thermal variation data as described in the primary outcomes, using the ImageReview software. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 or greater, of either gender and of any ethnic background
- Able to tolerate position change(s) and turns for up to 10 minutes comfortably
- Have an existing external wound or body surface area of interest:
- Have qualifying external wound or body surface area of interest:
Key exclusion criteria (12 listed)
- Neonatal and pediatric patients
- Pregnant women
- Cannot tolerate position changes for up to 10 minutes comfortably (per external wound site imaged)
- On therapies or treatments which cannot be safely suspended long enough to conduct an imaging session as determined by facility policy
- Have a wound dressing or medical device which cannot or should not be removed as determined by site investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scout takes visual and thermal images of external woundsAlso: Wound Measuring and Monitoring System/WMMS (past)All images are taken after the wound has acclimated. | Device | subjects with external wounds |
| ImageReview's visual perimeter trace of the external woundTrace is drawn by the study staff using the ImageReview software. | Device | subjects with external wounds |
| ImageReview's External Wound Trace OverlayStudy staff overlay the trace of the visual external wound's perimeter onto the corresponding thermal image of the external wound. | Device | subjects with external wounds |
| ImageReview's unaffected reference area selectedStudy Staff select an unaffected reference area of an adjacent body surface. | Device | subjects with external wounds |
| Adjacent tissue trace of the wound trace overlayStudy staff select an adjacent tissue trace of the wound trace overlay | Device | subjects with external wounds |
Primary outcome
Pixel gradient of the thermal wound surface
Time frame: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
Pixel gradient of the thermal wound surface will be measured, with changes documented during regularly scheduled wound care visits for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years.
Mean pixel value of the thermal wound surface
Time frame: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
Mean pixel value of the thermal wound surface will be measured, with changes documented during regularly scheduled wound care visits for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years.
Mode pixel value of the thermal wound surface
Time frame: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
Mode pixel value of the thermal wound surface will be measured, with changes documented during regularly scheduled wound care visits at the wound clinic for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years.
Pixel gradient of the thermal unaffected area of body surface selected
Time frame: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
Pixel gradient of the the thermal unaffected area of body surface selected will be measured, with changes documented during regularly scheduled wound care visits for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years.
Highest pixel value of the thermal wound surface
Time frame: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
Highest pixel value of the thermal wound surface will be measured, with changes documented during regularly scheduled wound care visits for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years.
Lowest pixel value of the thermal wound surface
Time frame: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
Lowest pixel value of the thermal wound surface will be measured, with changes documented during regularly scheduled wound care visits for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years.
Comparison of adjacent tissue trace around the wound bed's surface's relative temperature (Centigrade and Fahrenheit) to the unaffected reference area's relative temperature (Centigrade and Fahrenheit).
Time frame: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
Comparison of adjacent tissue trace around the wound bed's surface's relative temperature (Centigrade and Fahrenheit) to the unaffected reference area's relative temperature (Centigrade and Fahrenheit), with changes documented during regularly scheduled wound care visits for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years.
Comparison of wound surface's relative temperature (Centigrade and Fahrenheit) to the unaffected reference area's relative temperature (Centigrade and Fahrenheit).
Time frame: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
Comparison of wound surface's relative temperature (Centigrade and Fahrenheit) to the unaffected reference area's relative temperature (Centigrade and Fahrenheit), with changes documented during regularly scheduled wound care visits for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years.
Wound surface's % relative temperature above, below, or equal to the unaffected reference area's temperature
Time frame: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
Wound surface's % relative temperature above, below, or equal to the unaffected reference area's relative temperature, with changes documented during regularly scheduled wound care visits for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two years.
Adjacent tissue trace's surface % relative temperature above, below, or equal to the unaffected reference area's temperature
Time frame: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented
Adjacent tissue trace's surface's % relative temperature above, below, or equal to the unaffected reference area's relative temperature, with changes documented during regularly scheduled wound care visits for a minimum of two visits and may continue at the discretion of the primary investigator and the subject until the subject no longer qualifies or the study is ended, when 100 subjects are enrolled or the study has completed two 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 Nov 2016.
Related trials for Wounds and Injuries
Not yet recruitingObservational study
Results of Medical and Nursing Record,PE, Blood Test and Radiological Examination ,Morality and Mobility of Multiple Trauma of Patient's
Trauma Centers/Statistics & Numerical Data, Trauma Blunt
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
Understanding and Enhancing Human Health and Movement
Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
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.
Aletha W. Tippett, M.D. principal investigator
Integrative Center for Healing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scout takes visual and thermal images of external wounds, ImageReview's visual perimeter trace of the external wound and ImageReview's External Wound Trace Overlay in people with Wounds and Injuries, run by Wound Vision 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 7 inclusion and 12 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 Nov 2016. 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?
Pixel gradient of the thermal wound surface (time frame: Weeks 1-104, with week 104 as an estimated time frame maximum, for which changes will be measured and documented). The study lists 10 primary outcomes in all. 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 Nov 2016.