Wound ComplicationNCT07562269
Using WoundPilot to Support Wound Care Decisions in Patients With Chronic Wounds
A study testing WoundPilot in people with Wound Complication and Wound Care, run by University Ghent at 1 site in Belgium.
Trial summary
This study evaluates whether a digital decision support tool, called WoundPilot, can help primary care nurses make more accurate and consistent decisions when caring for patients with chronic wounds. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wound Complication, Wound Care, Wound and Injuries
- What is being tested?
- WoundPilot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Primary care nurses involved in wound care decision-making
- Nurses working in home care or nursing home settings
- Nurses who assess and/or adapt wound management in clinical practice
- Nurses with a qualification corresponding to European Qualification Framework (EQF) level 5 or 6
- Willing and able to provide informed consent
Who cannot join
- Nurses not involved in wound care decision-making
- Nurses not working in a primary care setting
- Inability to understand the study procedures or complete the assessment tasks
- Refusal or inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
Ghent University Hospital
Ghent, Oost-Vlaanderen, 9000
Steven Smet, Master, +3293328793, Steven.Smet@UZGent.be
Hilde Beele, PhD, +3293323381, Hilde.Beele@uzgent.be
About this study
Official title: Evaluation of the Effect of WoundPilot on the Accuracy and Consistency of Clinical Decision-Making in Chronic Wound Care: A Randomized Parallel Vignette Study Among Primary Care Nurses
This study evaluates whether a digital decision support tool, called WoundPilot, can help primary care nurses make more accurate and consistent decisions when caring for patients with chronic wounds.
In daily practice, treatment decisions for chronic wounds can vary between clinicians, even when they assess the same patient. This variation may lead to delays in appropriate care, inconsistent treatment choices, or unnecessary referrals. WoundPilot was developed to guide clinicians through a structured wound assessment and link this assessment to clear treatment recommendations.
Read more
In this study, primary care nurses will assess a series of clinical cases either with or without the support of WoundPilot. Their decisions will be compared with an expert reference standard to determine whether the use of WoundPilot improves the accuracy of decisions and reduces differences between nurses.
The results of this study will help determine whether WoundPilot can support more consistent and evidence-based wound care in clinical practice.
Read the detailed description
Background Clinical decision-making in chronic wound care shows considerable variability, even when clinicians are presented with similar patient information. This variability may result in delayed or inappropriate treatment, inconsistent use of therapies, or failure to escalate care when clinically indicated.
Structured clinical decision support systems (CDSS) aim to reduce unwarranted variation by guiding clinicians through predefined assessment steps and linking these to management pathways. WoundPilot is an evidence-informed CDSS developed to support structured wound assessment and treatment decision-making in primary care.
Objective The primary objective is to evaluate the effect of WoundPilot on the accuracy and consistency of clinical decision-making in chronic wound care among primary care nurses.
Secondary objectives are to:
- Assess alignment of wound assessment decisions with an expert reference standard
- Evaluate whether WoundPilot reduces variability between nurses
- Assess whether nurses better recognize and translate clinical changes
- Evaluate usability of WoundPilot using the Dutch System Usability Scale (D-SUS)
Study Design
This study is a randomized parallel vignette study conducted among primary care nurses. Participants are randomly assigned to:
- Intervention group: assessment of clinical cases using WoundPilot
- Control group: assessment based on usual clinical reasoning without decision support Each participant evaluates a set of standardized clinical cases representing patients with chronic wounds.
Methods Participants include primary care nurses involved in wound care decision-making in home care or nursing home settings.
In the intervention group, participants receive a short training on WoundPilot and use the tool to assess clinical cases. In the control group, participants assess the same type of cases using their usual reasoning and verbalize their decision-making process.
For each case, participants make decisions regarding wound assessment and treatment planning, including supportive therapy, antimicrobial use, debridement, dressing selection, and referral.
An expert reference standard is established by a panel of wound care experts. Participant decisions are compared to this reference.
Outcomes
The primary outcome is the correctness of treatment decisions compared with the expert reference standard. Secondary outcomes include:
- Correctness of wound assessment decisions
- Between-nurse variability in decisions
- Recognition and interpretation of clinical change
- Usability of WoundPilot (Dutch System Usability Scale) Agreement with the expert reference and between participants will be quantified using appropriate statistical methods, including kappa statistics and mixed-effects models.
Significance This study evaluates whether a structured clinical decision support system can improve the accuracy and consistency of clinical decision-making in chronic wound care. Findings may inform the role of digital decision support tools in supporting evidence-based practice in primary care.
- Conditions
- Wound Complication, Wound Care, Wound and Injuries
- Being tested
- WoundPilot
- Keywords
- chronic wound, wound care, clinical decision-making, decision support system, WoundPilot, Primary Care Nursing, Wound Assessment, decision-making, clinical reasoning, hard-to-heal wound
- 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.
WoundPilotDevice
WoundPilot is a software-based clinical decision support system (CDSS) designed to support structured wound assessment and treatment decision-making in primary care.
The system guides users through a stepwise assessment process using predefined decision nodes, including evaluation of wound etiology, infection, wound evolution, wound bed characteristics, exudate, and wound edges. Based on the entered information, WoundPilot provides structured guidance to support treatment planning, including recommendations on supportive therapy, local wound management, and referral.
The system incorporates evidence-informed clinical pathways and aims to standardize wound assessment and reduce variability in clinical decision-making.
| Study group | Role | What they receive |
|---|---|---|
| Reasoning with decision support | Experimental | Participants in this arm assess standardized clinical cases of patients with chronic wounds using WoundPilot, a digital clinical decision support system (CDSS).
WoundPilot guides users through a structured, stepwise wound assessment, including evaluation of wound etiology, infection, wound evolution, wound bed characteristics, exudate, and wound edges. Based on the assessment, the system provides structured guidance to support treatment decision-making, including recommendations on supportive therapy, local wound management, and referral.
Participants receive a brief training on the use of WoundPilot prior to the assessment and then independently evaluate a set of clinical cases using the tool. Receives: Device: WoundPilot |
| Usual reasoning | No intervention | Participants in this arm assess standardized clinical cases of patients with chronic wounds using their usual clinical reasoning, without the support of a clinical decision support system. Participants independently evaluate each case and make decisions regarding wound assessment and treatment planning, including supportive therapy, local wound management, and referral. They are asked to verbalize their reasoning during the assessment process, which is recorded for subsequent analysis. No additional training or decision support tool is provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Treatment Decisions Compared With an Expert Reference Standard
Accuracy of treatment decisions will be assessed by comparing each participant's treatment decisions for standardized chronic wound cases with an expert reference standard. Treatment decisions include supportive therapy, antimicrobial therapy, wound cleansing, debridement, choice of wound product, management of wound edges or wound environment, protection of exposed bone or tendon when applicable, referral or contact with another healthcare professional or department, wound swab, and additional technical investigations. Accuracy will be analyzed at the level of individual treatment decision components and as a composite correctness score per case.
Measured: During a single assessment session (approximately 2 hours)
Secondary outcomes (5)
Alignment of Wound Assessment Decisions With Expert Reference Standard
Accuracy of wound assessment decisions will be evaluated by comparing participant assessments with an expert reference standard. This includes classification of wound type, assessment of infection (local, spreading, or systemic), evaluation of wound evolution, wound bed characteristics, presence of hypergranulation or exposed structures, amount of exudate, and assessment of wound edges and surrounding skin.
Measured: During a single assessment session (approximately 2 hours)
Between-Nurse Variability in Treatment Decisions
Variability in treatment decisions between participants will be assessed within each study group. Agreement between participants will be quantified using statistical measures such as Fleiss' kappa to evaluate consistency of treatment decisions across standardized cases.
Measured: During a single assessment session (approximately 2 hours)
Between-Nurse Variability in Wound Assessment Decisions
Variability in wound assessment decisions between participants will be evaluated within each study group. Agreement will be quantified using appropriate statistical methods (e.g., Fleiss' kappa) to assess consistency in the evaluation of decision-critical wound parameters.
Measured: During a single assessment session (approximately 2 hours)
Recognition and Interpretation of Clinical Change
Participants' ability to recognize and correctly interpret clinical changes over time will be assessed by comparing decisions between initial and follow-up case scenarios. Correct identification of wound evolution and appropriate adaptation of treatment decisions will be evaluated against the expert reference standard.
Measured: During a single assessment session (approximately 2 hours)
Usability of WoundPilot (Dutch System Usability Scale)
Usability of WoundPilot will be assessed using the Dutch System Usability Scale (D-SUS), a validated 10-item questionnaire scored on a 5-point Likert scale. The D-SUS provides a total score ranging from 0 to 100, with higher scores indicating better usability.
Measured: During a single assessment session (approximately 2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Wound ComplicationStudies of the same condition, open and under way.
- More trials run by University GhentThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group uses WoundPilot, the other group uses usual clinical reasoning.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Smet, Master, Study chair, University Hospital, GhentHilde Beele, PhD, Principal investigator, University Hospital, GhentDimitri Beeckman, PhD, Study chair, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562269
- Sponsor's protocol ID
- ONZ-2026-0172
- Other IDs
- WoundPilot
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to the small sample size and the risk of potential re-identification of participants, as well as the inclusion of qualitative data (e.g., verbalized reasoning) that may contain indirectly identifiable information.
Publications
Smet S, Verhaeghe S, Beeckman D, Fourie A, Beele H. The process of clinical decision-making in chronic wound care: A scenario-based think-aloud study. J Tissue Viability. 2024 May;33(2):231-238. doi: 10.1016/j.jtv.2024.03.002. Epub 2024 Mar 1.
PubMed 38461069Smet S, Probst S, Holloway S, Fourie A, Beele H, Beeckman D. The measurement properties of assessment tools for chronic wounds: A systematic review. Int J Nurs Stud. 2021 Sep;121:103998. doi: 10.1016/j.ijnurstu.2021.103998. Epub 2021 Jun 7.
PubMed 34237439
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of WoundPilot on the Accuracy and Consistency of Clinical Decision-Making in Chronic Wound Care: A Randomized Parallel Vignette Study Among Primary Care Nurses
- ClinicalTrials.gov ID
- NCT07562269
- Acronym / sponsor ID
- ONZ-2026-0172
- Conditions
- Wound Complication, Wound Care, Wound and Injuries
- Keywords
- chronic wound, wound care, clinical decision-making, decision support system, WoundPilot, Primary Care Nursing, Wound Assessment, decision-making
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 1 May 2026 (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.
This study evaluates whether a digital decision support tool, called WoundPilot, can help primary care nurses make more accurate and consistent decisions when caring for patients with chronic wounds.
In daily practice, treatment decisions for chronic wounds can vary between clinicians, even when they assess the same patient. This variation may lead to delays in appropriate care, inconsistent treatment choices, or unnecessary referrals. WoundPilot was developed to guide clinicians through a structured wound assessment and link this assessment to clear treatment recommendations.
In this study, primary care nurses will assess a series of clinical cases either with or without the support of WoundPilot. Their decisions will be compared with an expert reference standard to determine whether the use of WoundPilot improves the accuracy of decisions and reduces differences between nurses.
The results of this study will help determine whether WoundPilot can support more consistent and evidence-based wound care in clinical practice.
Detailed description
Background Clinical decision-making in chronic wound care shows considerable variability, even when clinicians are presented with similar patient information. This variability may result in delayed or inappropriate treatment, inconsistent use of therapies, or failure to escalate care when clinically indicated.
Structured clinical decision support systems (CDSS) aim to reduce unwarranted variation by guiding clinicians through predefined assessment steps and linking these to management pathways. WoundPilot is an evidence-informed CDSS developed to support structured wound assessment and treatment decision-making in primary care.
Objective The primary objective is to evaluate the effect of WoundPilot on the accuracy and consistency of clinical decision-making in chronic wound care among primary care nurses.
Secondary objectives are to:
- Assess alignment of wound assessment decisions with an expert reference standard
- Evaluate whether WoundPilot reduces variability between nurses
- Assess whether nurses better recognize and translate clinical changes
- Evaluate usability of WoundPilot using the Dutch System Usability Scale (D-SUS)
Study Design
This study is a randomized parallel vignette study conducted among primary care nurses. Participants are randomly assigned to:
- Intervention group: assessment of clinical cases using WoundPilot
- Control group: assessment based on usual clinical reasoning without decision support Each participant evaluates a set of standardized clinical cases representing patients with chronic wounds.
Methods Participants include primary care nurses involved in wound care decision-making in home care or nursing home settings.
In the intervention group, participants receive a short training on WoundPilot and use the tool to assess clinical cases. In the control group, participants assess the same type of cases using their usual reasoning and verbalize their decision-making process.
For each case, participants make decisions regarding wound assessment and treatment planning, including supportive therapy, antimicrobial use, debridement, dressing selection, and referral.
An expert reference standard is established by a panel of wound care experts. Participant decisions are compared to this reference.
Outcomes
The primary outcome is the correctness of treatment decisions compared with the expert reference standard. Secondary outcomes include:
- Correctness of wound assessment decisions
- Between-nurse variability in decisions
- Recognition and interpretation of clinical change
- Usability of WoundPilot (Dutch System Usability Scale) Agreement with the expert reference and between participants will be quantified using appropriate statistical methods, including kappa statistics and mixed-effects models.
Significance This study evaluates whether a structured clinical decision support system can improve the accuracy and consistency of clinical decision-making in chronic wound care. Findings may inform the role of digital decision support tools in supporting evidence-based practice in primary care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One group uses WoundPilot, the other group uses usual clinical reasoning.
| Arm | Type | Receives |
|---|---|---|
| Reasoning with decision support | Experimental | Device: WoundPilotParticipants in this arm assess standardized clinical cases of patients with chronic wounds using WoundPilot, a digital clinical decision support system (CDSS). WoundPilot guides users through a structured, stepwise wound assessment, including evaluation of wound etiology, infection, wound evolution, wound bed characteristics, exudate, and wound edges. Based on the assessment, the system provides structured guidance to support treatment decision-making, including recommendations on supportive therapy, local wound management, and referral. Participants receive a brief training on the use of WoundPilot prior to the assessment and then independently evaluate a set of clinical cases using the tool. |
| Usual reasoning | No intervention | –Participants in this arm assess standardized clinical cases of patients with chronic wounds using their usual clinical reasoning, without the support of a clinical decision support system. Participants independently evaluate each case and make decisions regarding wound assessment and treatment planning, including supportive therapy, local wound management, and referral. They are asked to verbalize their reasoning during the assessment process, which is recorded for subsequent analysis. No additional training or decision support tool is provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary care nurses involved in wound care decision-making
- Nurses working in home care or nursing home settings
- Nurses who assess and/or adapt wound management in clinical practice
- Nurses with a qualification corresponding to European Qualification Framework (EQF) level 5 or 6
- Willing and able to provide informed consent
Key exclusion criteria (4 listed)
- Nurses not involved in wound care decision-making
- Nurses not working in a primary care setting
- Inability to understand the study procedures or complete the assessment tasks
- Refusal or inability to provide informed consent
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 |
|---|---|---|
| WoundPilotWoundPilot is a software-based clinical decision support system (CDSS) designed to support structured wound assessment and treatment decision-making in primary care. The system guides users through a stepwise assessment process using predefined decision nodes, including evaluation of wound etiology, infection, wound evolution, wound bed characteristics, exudate, and wound edges. Based on the entered information, WoundPilot provides structured guidance to support treatment planning, including recommendations on supportive therapy, local wound management, and referral. The system incorporates evidence-informed clinical pathways and aims to standardize wound assessment and reduce variability in clinical decision-making. | Device | Reasoning with decision support |
Primary outcome
Accuracy of Treatment Decisions Compared With an Expert Reference Standard
Time frame: During a single assessment session (approximately 2 hours)
Accuracy of treatment decisions will be assessed by comparing each participant's treatment decisions for standardized chronic wound cases with an expert reference standard. Treatment decisions include supportive therapy, antimicrobial therapy, wound cleansing, debridement, choice of wound product, management of wound edges or wound environment, protection of exposed bone or tendon when applicable, referral or contact with another healthcare professional or department, wound swab, and additional technical investigations. Accuracy will be analyzed at the level of individual treatment decision components and as a composite correctness score per case.
5 secondary outcomes
Alignment of Wound Assessment Decisions With Expert Reference Standard
Time frame: During a single assessment session (approximately 2 hours)
Between-Nurse Variability in Treatment Decisions
Time frame: During a single assessment session (approximately 2 hours)
Between-Nurse Variability in Wound Assessment Decisions
Time frame: During a single assessment session (approximately 2 hours)
Recognition and Interpretation of Clinical Change
Time frame: During a single assessment session (approximately 2 hours)
Usability of WoundPilot (Dutch System Usability Scale)
Time frame: During a single assessment session (approximately 2 hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Background: PubMed 38461069Smet S, Verhaeghe S, Beeckman D, Fourie A, Beele H. The process of clinical decision-making in chronic wound care: A scenario-based think-aloud study. J Tissue Viability. 2024 May;33(2):231-238. doi: 10.1016/j.jtv.2024.03.002. Epub 2024 Mar 1.
- Background: PubMed 34237439Smet S, Probst S, Holloway S, Fourie A, Beele H, Beeckman D. The measurement properties of assessment tools for chronic wounds: A systematic review. Int J Nurs Stud. 2021 Sep;121:103998. doi: 10.1016/j.ijnurstu.2021.103998. Epub 2021 Jun 7.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to the small sample size and the risk of potential re-identification of participants, as well as the inclusion of qualitative data (e.g., verbalized reasoning) that may contain indirectly identifiable information.
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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.
Steven Smet, Master study chair
University Hospital, Ghent
Hilde Beele, PhD principal investigator
University Hospital, Ghent
Dimitri Beeckman, PhD study chair
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WoundPilot in people with Wound Complication and Wound Care, run by University Ghent at 1 site in Belgium.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 1 May 2026. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steven Smet, Master (+3293328793, Steven.Smet@UZGent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Treatment Decisions Compared With an Expert Reference Standard (time frame: During a single assessment session (approximately 2 hours)). 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 NCT07562269, which also lists 2 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 1 May 2026.