Advanced Cutaneous Evaluator (ACE): Estimation of Clinical and Economic Impact
NCT07275385 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 73
Last updated 2025-12-10
Summary
ACE is a clinical decision support system for selecting appropriate products for the local treatment of chronic wounds. It was designed with a user-centered approach, and its usability and feasibility have been previously validated in pilot studies with nurses. This protocol will allow for the clinical validation of the software in 18 primary care centers, including the quantification of the clinical and economic effects of using the tool over 9 months. It is a mixed-methods design that includes a randomized controlled trial in which nursing staff incorporate the use of ACE into their routine clinical practice to support their decision-making process for chronic wound treatment. It also includes a usability evaluation throughout the study.
Conditions
- Wounds and Injuries
- Wound Complication
Interventions
- DEVICE
-
Advanced Cutaneous Evaluator (ACE)
Nursing staff include the use of ACE in their routine clinical practice to support their chronic wound treatment decision-making process.
- OTHER
-
Control (non-ACE)
Professionals in the non-ACE group will carry out their usual clinical practice of chronic wound care.
Sponsors & Collaborators
-
Fundacin Biomedica Galicia Sur
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-03-26
- Primary Completion
- 2025-10-23
- Completion
- 2025-11-06
Countries
- Spain
Study Locations
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