Using WoundPilot to Support Wound Care Decisions in Patients With Chronic Wounds

NCT07562269 | Not Yet Recruiting

• 2 other identifiers: ONZ-2026-0172WoundPilot
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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; clinical reasoning; hard-to-heal wound

Outcome Measures

Primary Outcomes (1)

• 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.

  During a single assessment session (approximately 2 hours)

Secondary Outcomes (5)

• Alignment of Wound Assessment Decisions With Expert Reference Standard

  During a single assessment session (approximately 2 hours)

• Between-Nurse Variability in Treatment Decisions

  During a single assessment session (approximately 2 hours)

• Between-Nurse Variability in Wound Assessment Decisions

  During a single assessment session (approximately 2 hours)

• Recognition and Interpretation of Clinical Change

  During a single assessment session (approximately 2 hours)

• Usability of WoundPilot (Dutch System Usability Scale)

  During a single assessment session (approximately 2 hours)

Study Arms (2)

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.

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.

Interventions

WoundPilot DEVICE

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.

Reasoning with decision support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Related Publications (2)

• 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.

  PMID: 38461069 BACKGROUND

• Smet 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.

  PMID: 34237439 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Steven Smet, Master

  University Hospital, Ghent

  STUDY CHAIR

• Hilde Beele, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

• Dimitri Beeckman, PhD

  University Ghent

  STUDY CHAIR

Central Study Contacts

Steven Smet, Master

CONTACT

+3293328793; Steven.Smet@UZGent.be

Hilde Beele, PhD

CONTACT

+32 9 332 33 81; Hilde.Beele@uzgent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group uses WoundPilot, the other group uses usual clinical reasoning.

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: May 1, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)