Pressure InjuryNCT06559657
Investigation of the Consistency Between Innovative Methods for Measuring the Area and Depth of Pressure Injuries
A study testing eKare Insight, imitoMeasure Mobile App, Visitrak in people with Pressure Injury and Innovativeness, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Wound healing is a complex process and wound care and evaluation is one of the most important problems in current medicine. Wounds are seen in clinics as diabetic foot ulcers (DFU), arterial and venous ulcers, pressure injuries, surgical wounds and so on. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Injury, Innovativeness, Wound
- What is being tested?
- eKare Insight, imitoMeasure Mobile App, Visitrak
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Aug 2022to 13 Mar 2024
- 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
- Being 18 years or older
- Volunteering to participate in research,
- Having at least Stage 2 pressure injury
Who cannot join
- Having Stage 1 pressure injuries
- Having a wound with a shape that makes 2D area measurement impossible
- Patients who cannot remain in the same position for a long time
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Compatibility Among Innovative Methods in Measuring the Area and Depth of Pressure Injuries
Wound healing is a complex process and wound care and evaluation is one of the most important problems in current medicine. Wounds are seen in clinics as diabetic foot ulcers (DFU), arterial and venous ulcers, pressure injuries, surgical wounds and so on. Pressure injuries (PI) have a high mortality rate (29%) among elderly individuals. The prevalence of PIs in different countries worldwide varies between 6% and 18.5% in acute care settings. Wound assessment is an integral part of nursing practice.
Improper assessment of wounds may lead to inadequate wound care, resulting in delayed wound healing, increased risk of infection, increased costs, and decreased patient quality of life. Wound measurement is a useful quantitative finding in wound assessment, used as a practical approach to monitor wound healing. An ideal wound measurement method should be practical, comfortable for the patient, high accuracy, reliability and applicability. In clinical practice, it is essential to regularly reassess wounds to monitor changes in size, depth, and appearance over time.
With the emergence of new techniques and technologies, there is a need for methods that can be considered as the gold standard in the measurement of wound dimensions. It is seen in the literature that studies comparing two- and three-dimensional measurement methods are generally carried out on superficial wounds and very limited wound types. In addition, there are hardly any studies comparing depth measurements with three-dimensional methods. In this direction, it was necessary to conduct this study in order to create evidence-based data in the field. The research has the quality of being the first and original study in our country that evaluates the compatibility of innovative methods in the area measurement of PIs and measures the wound depth.
Read the detailed description
Hypotheses H1: There is concordance between digital planimetry and the imitoMeasure mobile application in measuring wound area.
H2: There is concordance between digital planimetry and three-dimensional wound area measurement in measuring wound area.
H3: There is concordance between the imitoMeasure mobile application and three-dimensional wound area measurement in measuring wound area.
H4: There is concordance between measurement with a sterile cotton swab and three-dimensional wound measurement in assessing wound depth.
Aim: The aim of this study is to examine the concordance between digital planimetry, the imitoMeasure mobile application, and three-dimensional wound measurement methods in measuring the area of pressure injuries, and to compare the measurement of wound depth using a sterile swab with the three-dimensional wound measurement method.
Research Place and Time: This study was conducted between April 2022 and April 2024 in the intensive care unit of the Department of Anesthesiology and Reanimation at Ege University Medical Faculty Hospital.
Data Collection:
For the purpose of data collection in this study, the following were used: the "Individual and Wound Identification Form," the "Informed Consent Form," the "Digital Planimetry Device (Visitrak™)," the "Smith \& Nephew Opsite Flexigrid Transparent Wound Dressing," the "imitoMeasure mobile application (iPhone 13)," the "eKare inSight device," and a "Sterile Cotton Swab."
- Conditions
- Pressure Injury, Innovativeness, Wound
- Being tested
- eKare Insight, imitoMeasure Mobile App, Visitrak
- Keywords
- Pressure Ulcer
- Medical subject headings
- Pressure Ulcer, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eKare Insight, imitoMeasure Mobile App, VisitrakDevice
The wound size of the patients was measured with three different methods. Wound depth was measured using manual method and three-dimensional imaging devices.
| Study group | Role | What they receive |
|---|---|---|
| Wound area and depth measurement | Experimental | The area of the pressure injuries was measured using digital planimetry, the imitoMeasure mobile application, and the three-dimensional wound measurement method. Depth was measured using a sterile cotton swab and the three-dimensional wound measurement method. Receives: Device: eKare Insight, imitoMeasure Mobile App, Visitrak |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound area measurment
It is the measurement of wound area with three different methods.
Measured: Approximately 5 minutes until the wound is selected and the measurement is completed.
Wound depth measurment
It is the measurement of wound depth with two different methods.
Measured: Approximately 5 minutes until the wound is selected and the measurement is completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start12 Aug 2022
- Primary completion13 Mar 2024
- Study completion13 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pressure InjuryStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gul SAHBUDAK, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559657
- Sponsor's protocol ID
- Nursing Faculty
- Status last verified
- Aug 2024
- First submitted
- 12 Aug 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Magny E, Vallet H, Cohen-Bittan J, Raux M, Meziere A, Verny M, Riou B, Khiami F, Boddaert J. Pressure ulcers are associated with 6-month mortality in elderly patients with hip fracture managed in orthogeriatric care pathway. Arch Osteoporos. 2017 Aug 29;12(1):77. doi: 10.1007/s11657-017-0365-9.
PubMed 28852954Anisuzzaman DM, Wang C, Rostami B, Gopalakrishnan S, Niezgoda J, Yu Z. Image-Based Artificial Intelligence in Wound Assessment: A Systematic Review. Adv Wound Care (New Rochelle). 2022 Dec;11(12):687-709. doi: 10.1089/wound.2021.0091. Epub 2021 Dec 20.
PubMed 34544270Tervo-Heikkinen TA, Heikkila A, Koivunen M, Kortteisto TR, Peltokoski J, Salmela S, Sankelo M, Ylitormanen TS, Junttila K. Pressure injury prevalence and incidence in acute inpatient care and related risk factors: A cross-sectional national study. Int Wound J. 2022 May;19(4):919-931. doi: 10.1111/iwj.13692. Epub 2021 Oct 4.
PubMed 34605185Tubaishat A, Papanikolaou P, Anthony D, Habiballah L. Pressure Ulcers Prevalence in the Acute Care Setting: A Systematic Review, 2000-2015. Clin Nurs Res. 2018 Jul;27(6):643-659. doi: 10.1177/1054773817705541. Epub 2017 Apr 27.
PubMed 28447852Little C, McDonald J, Jenkins MG, McCarron P. An overview of techniques used to measure wound area and volume. J Wound Care. 2009 Jun;18(6):250-3. doi: 10.12968/jowc.2009.18.6.42804.
PubMed 19661849Khong PCB, Yeo MSW, Goh CC. Evaluating an iPad app in measuring wound dimension: a pilot study. J Wound Care. 2017 Dec 2;26(12):752-760. doi: 10.12968/jowc.2017.26.12.752.
PubMed 29244972Keast DH, Bowering CK, Evans AW, Mackean GL, Burrows C, D'Souza L. MEASURE: A proposed assessment framework for developing best practice recommendations for wound assessment. Wound Repair Regen. 2004 May-Jun;12(3 Suppl):S1-17. doi: 10.1111/j.1067-1927.2004.0123S1.x.
PubMed 15230830Pena G, Kuang B, Szpak Z, Cowled P, Dawson J, Fitridge R. Evaluation of a Novel Three-Dimensional Wound Measurement Device for Assessment of Diabetic Foot Ulcers. Adv Wound Care (New Rochelle). 2020 Nov;9(11):623-631. doi: 10.1089/wound.2019.0965. Epub 2019 Oct 23.
PubMed 33095125Sahbudak G, Gunes U. Comparing Digital, Mobile and Three-Dimensional Methods in Pressure Injury Measurement: Agreement in Surface Area and Depth Assessments. J Clin Nurs. 2026 Jan;35(1):172-181. doi: 10.1111/jocn.17813. Epub 2025 May 9.
PubMed 40346762
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Compatibility Among Innovative Methods in Measuring the Area and Depth of Pressure Injuries
- ClinicalTrials.gov ID
- NCT06559657
- Acronym / sponsor ID
- Nursing Faculty
- Conditions
- Pressure Injury, Innovativeness, Wound
- Keywords
- Pressure Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 12 Aug 2022 (actual)
- Primary completion
- 13 Mar 2024 (actual)
- Study completion
- 13 Mar 2024 (actual)
- First posted
- 19 Aug 2024 (actual)
- 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.
Wound healing is a complex process and wound care and evaluation is one of the most important problems in current medicine. Wounds are seen in clinics as diabetic foot ulcers (DFU), arterial and venous ulcers, pressure injuries, surgical wounds and so on. Pressure injuries (PI) have a high mortality rate (29%) among elderly individuals. The prevalence of PIs in different countries worldwide varies between 6% and 18.5% in acute care settings. Wound assessment is an integral part of nursing practice.
Improper assessment of wounds may lead to inadequate wound care, resulting in delayed wound healing, increased risk of infection, increased costs, and decreased patient quality of life. Wound measurement is a useful quantitative finding in wound assessment, used as a practical approach to monitor wound healing. An ideal wound measurement method should be practical, comfortable for the patient, high accuracy, reliability and applicability. In clinical practice, it is essential to regularly reassess wounds to monitor changes in size, depth, and appearance over time.
With the emergence of new techniques and technologies, there is a need for methods that can be considered as the gold standard in the measurement of wound dimensions. It is seen in the literature that studies comparing two- and three-dimensional measurement methods are generally carried out on superficial wounds and very limited wound types. In addition, there are hardly any studies comparing depth measurements with three-dimensional methods. In this direction, it was necessary to conduct this study in order to create evidence-based data in the field. The research has the quality of being the first and original study in our country that evaluates the compatibility of innovative methods in the area measurement of PIs and measures the wound depth.
Detailed description
Hypotheses H1: There is concordance between digital planimetry and the imitoMeasure mobile application in measuring wound area.
H2: There is concordance between digital planimetry and three-dimensional wound area measurement in measuring wound area.
H3: There is concordance between the imitoMeasure mobile application and three-dimensional wound area measurement in measuring wound area.
H4: There is concordance between measurement with a sterile cotton swab and three-dimensional wound measurement in assessing wound depth.
Aim: The aim of this study is to examine the concordance between digital planimetry, the imitoMeasure mobile application, and three-dimensional wound measurement methods in measuring the area of pressure injuries, and to compare the measurement of wound depth using a sterile swab with the three-dimensional wound measurement method.
Research Place and Time: This study was conducted between April 2022 and April 2024 in the intensive care unit of the Department of Anesthesiology and Reanimation at Ege University Medical Faculty Hospital.
Data Collection:
For the purpose of data collection in this study, the following were used: the "Individual and Wound Identification Form," the "Informed Consent Form," the "Digital Planimetry Device (Visitrak™)," the "Smith \& Nephew Opsite Flexigrid Transparent Wound Dressing," the "imitoMeasure mobile application (iPhone 13)," the "eKare inSight device," and a "Sterile Cotton Swab."
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wound area and depth measurement | Experimental | Device: eKare Insight, imitoMeasure Mobile App, VisitrakThe area of the pressure injuries was measured using digital planimetry, the imitoMeasure mobile application, and the three-dimensional wound measurement method. Depth was measured using a sterile cotton swab and the three-dimensional wound measurement method. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being 18 years or older
- Volunteering to participate in research,
- Having at least Stage 2 pressure injury
Key exclusion criteria (3 listed)
- Having Stage 1 pressure injuries
- Having a wound with a shape that makes 2D area measurement impossible
- Patients who cannot remain in the same position for a long time
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 |
|---|---|---|
| eKare Insight, imitoMeasure Mobile App, VisitrakThe wound size of the patients was measured with three different methods. Wound depth was measured using manual method and three-dimensional imaging devices. | Device | Wound area and depth measurement |
Primary outcome
Wound area measurment
Time frame: Approximately 5 minutes until the wound is selected and the measurement is completed.
It is the measurement of wound area with three different methods.
Wound depth measurment
Time frame: Approximately 5 minutes until the wound is selected and the measurement is completed.
It is the measurement of wound depth with two different methods.
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 19 Aug 2024.
- Results publication: PubMed 28852954Magny E, Vallet H, Cohen-Bittan J, Raux M, Meziere A, Verny M, Riou B, Khiami F, Boddaert J. Pressure ulcers are associated with 6-month mortality in elderly patients with hip fracture managed in orthogeriatric care pathway. Arch Osteoporos. 2017 Aug 29;12(1):77. doi: 10.1007/s11657-017-0365-9.
- Results publication: PubMed 34544270Anisuzzaman DM, Wang C, Rostami B, Gopalakrishnan S, Niezgoda J, Yu Z. Image-Based Artificial Intelligence in Wound Assessment: A Systematic Review. Adv Wound Care (New Rochelle). 2022 Dec;11(12):687-709. doi: 10.1089/wound.2021.0091. Epub 2021 Dec 20.
- Results publication: PubMed 34605185Tervo-Heikkinen TA, Heikkila A, Koivunen M, Kortteisto TR, Peltokoski J, Salmela S, Sankelo M, Ylitormanen TS, Junttila K. Pressure injury prevalence and incidence in acute inpatient care and related risk factors: A cross-sectional national study. Int Wound J. 2022 May;19(4):919-931. doi: 10.1111/iwj.13692. Epub 2021 Oct 4.
- Results publication: PubMed 28447852Tubaishat A, Papanikolaou P, Anthony D, Habiballah L. Pressure Ulcers Prevalence in the Acute Care Setting: A Systematic Review, 2000-2015. Clin Nurs Res. 2018 Jul;27(6):643-659. doi: 10.1177/1054773817705541. Epub 2017 Apr 27.
- Results publication: PubMed 19661849Little C, McDonald J, Jenkins MG, McCarron P. An overview of techniques used to measure wound area and volume. J Wound Care. 2009 Jun;18(6):250-3. doi: 10.12968/jowc.2009.18.6.42804.
- Results publication: PubMed 29244972Khong PCB, Yeo MSW, Goh CC. Evaluating an iPad app in measuring wound dimension: a pilot study. J Wound Care. 2017 Dec 2;26(12):752-760. doi: 10.12968/jowc.2017.26.12.752.
- Results publication: PubMed 15230830Keast DH, Bowering CK, Evans AW, Mackean GL, Burrows C, D'Souza L. MEASURE: A proposed assessment framework for developing best practice recommendations for wound assessment. Wound Repair Regen. 2004 May-Jun;12(3 Suppl):S1-17. doi: 10.1111/j.1067-1927.2004.0123S1.x.
- Results publication: PubMed 33095125Pena G, Kuang B, Szpak Z, Cowled P, Dawson J, Fitridge R. Evaluation of a Novel Three-Dimensional Wound Measurement Device for Assessment of Diabetic Foot Ulcers. Adv Wound Care (New Rochelle). 2020 Nov;9(11):623-631. doi: 10.1089/wound.2019.0965. Epub 2019 Oct 23.
- Derived from this study: PubMed 40346762Sahbudak G, Gunes U. Comparing Digital, Mobile and Three-Dimensional Methods in Pressure Injury Measurement: Agreement in Surface Area and Depth Assessments. J Clin Nurs. 2026 Jan;35(1):172-181. doi: 10.1111/jocn.17813. Epub 2025 May 9.
- Individual participant dataSharing planned: Undecided
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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?
A study testing eKare Insight, imitoMeasure Mobile App, Visitrak in people with Pressure Injury and Innovativeness, run by Ege University at 1 site in Turkey (Türkiye).
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 3 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 19 Aug 2024. 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 Turkey (Türkiye). 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?
Wound area measurment (time frame: Approximately 5 minutes until the wound is selected and the measurement is completed.). 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?
On the ClinicalTrials.gov record for NCT06559657, which also lists 9 linked publications.
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 19 Aug 2024.