Pressure UlcerNCT02705443
Early Identification of Suspected Deep Tissue Injury (sDTI)
An observational study of Pressure Ulcer and Bed Sore, run by Wound Vision at 1 site in United States.
Trial summary
The purpose of this study is to further clarify existing research on the early identification and documentation of suspected deep tissue injury (sDTI). Basic principles of physiology along with prior research suggests that sDTI has quantifiable amounts of heat (or lack thereof) relative to surrounding tissue that will… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcer, Bed Sore
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Jun 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects admitted to a long-term acute care hospital (LTACH).
Who may be able to join
- 18 years of age or older
- Can tolerate position changes ≥ 10 minutes
- Non-pregnant
Who cannot join
- Therapies/treatments cannot be safely suspended to for an imaging session
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kindred Hospital Dayton
Dayton, Ohio, 45417
Richard Simman, M.D., 937-604-7377, Richardsimman@hotmail.com
About this study
Official title: Early Identification of Suspected Deep Tissue Injury (sDTI) Utilizing Long-Wave Thermographic Imaging (LWIT)
The purpose of this study is to further clarify existing research on the early identification and documentation of suspected deep tissue injury (sDTI). Basic principles of physiology along with prior research suggests that sDTI has quantifiable amounts of heat (or lack thereof) relative to surrounding tissue that will exhibit characteristic thermal signatures (temperature). These signatures will be measured and quantitatively recorded using long-wave infrared thermography (LWIT) to not only identify sDTI, but to also learn more about their pathophysiological evolution. Additionally, the LWIT physiological data will be cross-compared to the gold standard of visual assessment and other current standards of wound evaluation.
- Conditions
- Pressure Ulcer, Bed Sore
- Being tested
- No Intervention
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
Standard of Care Only
| Study group | Role | What they receive |
|---|---|---|
| Tissue w/ Thermographic Anomaly | * Visibly undamaged tissue with anomaly identified by the thermographic image
* No intervention
* Standard of care Receives: Other: No Intervention | |
| Tissue w/o Thermographic Anomaly | * Visibly undamaged tissue with no anomaly identified by the thermographic image
* No intervention
* Standard of care Receives: Other: No Intervention | |
| Tissue w/ Visible Anomaly | * Visibly damaged tissue
* No intervention
* Standard of care Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of anatomical areas with intact skin and a thermographic anomaly that progress to a stageable pressure ulcer
Sensitivity and specificity of a thermographic anomaly that progresses to a stageable pressure ulcer
Measured: Up to 25 days
Number of anatomical areas with intact skin and a thermographic anomaly that do not progress to a stageable pressure ulcer
Sensitivity and specificity of a thermographic anomaly that does not progress to a stageable pressure ulcer
Measured: Up to 25 days
Secondary outcomes (1)
Temperature change associated with anatomical areas after a stageable pressure ulcer occurs
Measured: Up to 25 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionMay 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wound Vision
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02705443
- Sponsor's protocol ID
- WV15CL-0001
- Status last verified
- Nov 2016
- First submitted
- 2 Mar 2016
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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
- Early Identification of Suspected Deep Tissue Injury (sDTI) Utilizing Long-Wave Thermographic Imaging (LWIT)
- ClinicalTrials.gov ID
- NCT02705443
- Acronym / sponsor ID
- WV15CL-0001
- Conditions
- Pressure Ulcer, Bed Sore
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wound VisionIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 10 Mar 2016 (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 further clarify existing research on the early identification and documentation of suspected deep tissue injury (sDTI). Basic principles of physiology along with prior research suggests that sDTI has quantifiable amounts of heat (or lack thereof) relative to surrounding tissue that will exhibit characteristic thermal signatures (temperature). These signatures will be measured and quantitatively recorded using long-wave infrared thermography (LWIT) to not only identify sDTI, but to also learn more about their pathophysiological evolution. Additionally, the LWIT physiological data will be cross-compared to the gold standard of visual assessment and other current standards of wound evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tissue w/ Thermographic Anomaly | – | Other: No Intervention* Visibly undamaged tissue with anomaly identified by the thermographic image * No intervention * Standard of care |
| Tissue w/o Thermographic Anomaly | – | Other: No Intervention* Visibly undamaged tissue with no anomaly identified by the thermographic image * No intervention * Standard of care |
| Tissue w/ Visible Anomaly | – | Other: No Intervention* Visibly damaged tissue * No intervention * Standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects admitted to a long-term acute care hospital (LTACH).
Key inclusion criteria (3 listed)
- 18 years of age or older
- Can tolerate position changes ≥ 10 minutes
- Non-pregnant
Key exclusion criteria (2 listed)
- Therapies/treatments cannot be safely suspended to for an imaging session
- Non-English speaking
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 |
|---|---|---|
| No InterventionStandard of Care Only | Other | Tissue w/ Thermographic Anomaly, Tissue w/ Visible Anomaly, Tissue w/o Thermographic Anomaly |
Primary outcome
Number of anatomical areas with intact skin and a thermographic anomaly that progress to a stageable pressure ulcer
Time frame: Up to 25 days
Sensitivity and specificity of a thermographic anomaly that progresses to a stageable pressure ulcer
Number of anatomical areas with intact skin and a thermographic anomaly that do not progress to a stageable pressure ulcer
Time frame: Up to 25 days
Sensitivity and specificity of a thermographic anomaly that does not progress to a stageable pressure ulcer
1 secondary outcome
Temperature change associated with anatomical areas after a stageable pressure ulcer occurs
Time frame: Up to 25 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Pressure Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Not yet recruiting
Pulsed High Intensity Laser Versus Negative Pressure Therapy On Neuropathic Ulcers
Neuropathic Ulcers
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Not yet recruiting
The Effectiveness of a Caregiver-Based Multicomponent Intervention to Prevent Pressure Ulcers in Home-Cared-For Individuals With Dementia
Dementia, Home Care for Elderly or Disabled Individuals
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
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.
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 Pressure Ulcer and Bed Sore, 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 3 inclusion and 2 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicholas A McMurray, Bachelor (3177756077, nick@woundvision.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of anatomical areas with intact skin and a thermographic anomaly that progress to a stageable pressure ulcer (time frame: Up to 25 days). The study lists 2 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.