Advanced Cutaneous Evaluator (ACE): Estimation of Clinical and Economic Impact (ACE)

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.

Study Overview

• Status: Completed
• Conditions: Wounds and Injuries; Wound Complication
• Intervention / Treatment: Other: Control (non-ACE); Device: Advanced Cutaneous Evaluator (ACE)

Detailed Description

To estimate the clinical and economic impact of ACE, wounds will be reviewed at baseline and every two weeks until closure or until the end of the study period. Wound size will be recorded, and whether or not the wound is closed will be noted, with a maximum follow-up period of 16 weeks. A follow-up will be conducted four weeks after wound closure to assess wound dehiscence or other adverse events. Given these wound follow-up periods, only wounds incurred during the first three months of the study, after the completion of professional recruitment and training, will be included for those assigned to the ACE group. A longitudinal study will be conducted in 18 primary care centers in Galicia.

Once the study period is complete, the clinical and economic impact will be evaluated by comparing the following indicators between the two groups: the primary outcome will be wound closure, and secondary outcomes will include wound evolution (including its size every two weeks from the first ulcer assessment and wound bed tissue assessment), length of hospital stay, readmissions, incidence of hospital-acquired injuries, and the cost of products used for wound treatment. Comparative analyses will be performed by subdividing the groups according to the users' experience in chronic wound treatment at the start of the study and according to the type of chronic wound. In addition, instances in which users in the ACE group choose not to follow the application's recommendations will be recorded and quantified.

To evaluate the usability and acceptability of ACE by nursing staff, validated quantitative and standardized tools will be used. Only professionals assigned to the ACE group will participate, using ACE as a decision support tool whenever they need to select products for wound treatment. On one day during the second week of months 2, 4, and 6, the usability and acceptance of the application will be evaluated by the professionals assigned to the ACE group using the System Usability Scale (SUS). Simultaneously, the NASA TLX scale, which quantifies mental workload as an aspect of usability, will be evaluated in both groups.

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Pontevedra, Spain, 36071
    • Complexo Hospitalario Universitario de Pontevedra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthcare professionals responsible for selecting products for the local treatment of chronic, curable wounds in adult patients.
• Patients with chronic wounds, aged 18 to 100 years.
• Patients with wounds healing by secondary intention, aged 18 to 100 years.
• Patients and/or professionals who have signed the informed consent form for the study.

Exclusion Criteria:

• Minors
• Wounds of patients with acute surgical wounds, aged between 18 and 100 years.
• Images containing features that allow patient identification, such as tattoos and/or moles, or where part of the face is visible.
• Wounds corresponding to third-degree burns, tumor wounds, ischemic ulcers, pyoderma gangrenosum, and ulcers with osteomyelitis without systemic antibiotic treatment.
• Patients and professionals who declined to participate after reading the report Informed Consent Form.

Exclusion criteria:

• During the study, exclusion criteria include wounds lost to follow-up before completing 4 weeks of treatment, except for those that complete follow-up due to wound healing and discharge. Additionally, healthcare professionals and patients who withdraw their consent and wish to leave the study will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control (non-ACE); professionals in the non-ACE group will carry out their usual clinical practice of healing chronic wounds and, in the same way as members of the ACE group, each time they make a decision about local treatment products for these wounds, they must record it in the data collection notebook.	Other: Control (non-ACE); Professionals in the non-ACE group will carry out their usual clinical practice of chronic wound care.
Experimental: ACE; The professionals assigned to the ACE group will recruit patients whose wounds will be photographed for use in the application. These images will not be saved but will be deleted immediately after each treatment consultation using the ACE application. Clinical judgment will always prevail. If the professional considers the treatments suggested by ACE unsuitable, they will not apply any of them; instead, they will treat the patient with what they deem best as a healthcare professional. For the purposes of this study, the healthcare professionals in the experimental group will use the software as a clinical decision support system to consult the products they recommend for wound treatment, recommending only wound care products commonly used in participating centers.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment group	ACE or non-ACE	Day 0
Health center	Open Field	Day 0
Training of healthcare professionals	Academic training of healthcare professionals	Day 0, at the start of the professional's participation
Years of experience of healthcare professionals	Years of experience of healthcare professionals in healing chronic wounds	Day 0, at the start of the professional's participation
SUS	Score obtained after completing the System Usability Scale questionnaire	At month 1, month 3 and month 5 after the professional's participation
NASA TLX	Score obtained after completing the NASA TLX questionnaire	At month 1, month 3 and month 5 after the professional's participation
Patient age	Patient's age in years	Day 0, at the start of recruitment
Gender	Male or female	Day 0, at the start of recruitment
Diseases	Indicate, if applicable, the following option(s): DM I or II, venous and/or arterial insufficiency, ischemia, obesity, osteomyelitis, diabetic neuropathy, others.	Day 0, at the start of recruitment
Allergies	Open field	Day 0, at the start of recruitment
Recurrent medication	Indicate, if applicable, the following option(s): Corticosteroids, NSAIDs, anticoagulants, others.	Day 0, at the start of recruitment
History of chronic wounds	Indicate, if applicable, etiology, highest classification, location, and if healed, the approximate closing date.	Day 0, at the start of recruitment
Number of wounds in the same patient	Number	Day 0 and follow-up day every 2 weeks until end of recruitment
Wound location	Open field	Day 0, at the start of recruitment
Date of first consultation	Date	Day 0, at the start of recruitment
Date of wound closure	Date	Day of wound closure after follow-up
Date of loss to follow-up (if applicable)	Date	Day of loss to follow-up after follow-up
Reason of loss to follow-up (if applicable)	Open field	Day of loss to follow-up after follow-up
Date of treatment decision	Date	Day 0 and follow-up day every 2 weeks until wound closure or end of study
Use of ACE?	Yes or No	Day 0 and follow-up day every 2 weeks until wound closure or end of study
Wound size	Width, length and depth (if applicable) measured in cm	Day 0 and follow-up day every 2 weeks until wound closure or end of study
Tissues in the wound bed	Indicate the following option(s): Necrotic, Sloughing, Granulation, Epithelial, Intact skin with erythema	Day 0 and follow-up day every 2 weeks until wound closure or end of study
Dominant tissue in the wound bed	Select one of the options: Necrotic, Sloughing, Granulation, Epithelial, Intact skin with erythema	Day 0 and follow-up day every 2 weeks until wound closure or end of study
Exudate level	Select one of the options: 0 none, 1 scarce, 2 moderate, 3 abundant	Day 0 and follow-up day every 2 weeks until wound closure or end of study
Condition of the perilesional skin	Indicate the following option(s): Macerated, Erythema or inflammation, Eczema, Fragile skin	Day 0 and follow-up day every 2 weeks until wound closure or end of study
Etiology of the wound	Select one of the options: LESCAH, Diabetic foot, Burn, Arterial, Pressure, Venous, Not determined	Day 0 and follow-up day every 2 weeks until wound closure or end of study
Category of the wound	Indicate the corresponding one according to the selected etiology: LESCAH: 1A/1B/2A/2B; Diabetic foot (Wagner): I/II/III/IV/V; Burn: 1st/2nd/2nd deep/3rd; Arterial: hypertensive ulcer (of Martorell)/arteriosclerotic ulcer/angitic ulcer (of Buerger); Pressure: I/II/III/IV; Venous: C2 (varicose veins)/C3 (edema)/C4a (pigmentation and/or eczema)/C4b (lipodermatosclerosis or white atrophy)/C5 (healed ulceration)/C6 (active ulceration).	Day 0 and follow-up day every 2 weeks until wound closure or end of study
Applied products	Indicate the following option(s): Actisorb plus 25, Allevyn Adhesive 12, Allevyn Gentle Border 7, Allevyn Heel 13, Allevyn Sacrum 22 x 22 cm, Aquacel Ag, Aquacel Ag + Extra, Aquacel Ag Tape, Aquacel Ag Foam, Aquacel tape, Aquacel Extra, Adhesive Aquacel Foam, Non-Adhesive Aquacel Foam, Aquacel foam pro, Askina carbosorb, Biatain Contact, Biatain non adhesive, Biatain, Silicone with border, Biatain Silicone Without Rim, Cavilon, Comfeel plus sacral, Comfeel plus transparent, Convamax Superabsorb, Conveen Protact, Corpitol, Topical corticosteroid, Cutimed Alginate, Cutimed Sorbact, Cutmed Epiona, Non-sterile Granudacyn, Transparent Hydrotac, Intrasite gel, Iodosorb, Iruxol, Mepilex Border Flex Lite, Mepilex border flex oval, Mepilex border sacrum, Microdacyn 60 Sterile, Trionic, Urgo K2, Urgoclean, Urgoclean AG, Urgostart Plus Pad, Urgotul, Urgotul AG, Varihesive Extra Fine, Varihesive Gel Control, Vliwaktiv AG, Others.	Day 0 and follow-up day every 2 weeks until wound closure or end of study
Date of Adverse Event (if applicable)	Date	Day 0, follow-up day every 2 weeks until wound closure or end of study and 4 weeks after the wound closed
Adverse Event classification (if applicable)	Indicate the following option(s): Severe, Not severe, Expected, Unexpected, Related, Possibly related, Not related	Day 0, follow-up day every 2 weeks until wound closure or end of study and 4 weeks after the wound closed
Description of Adverse Event (if applicable)	Open field describing the event, device deficiency (if applicable), clinical signs, clinical impact, patient action/treatment/outcome.	Day 0, follow-up day every 2 weeks until wound closure or end of study and 4 weeks after the wound closed
Measure taken after Adverse Event (if applicable)	Select one of the options: None, Change of treatment, Other.	Day 0, follow-up day every 2 weeks until wound closure or end of study and 4 weeks after the wound closed
Outcome of the Adverse Event (if applicable)	Select one of the options: Recovered, Recovering, Not recovered, Recovered with sequelae, Fatal, Unknown	Day 0, follow-up day every 2 weeks until wound closure or end of study and 4 weeks after the wound closed
Date of resolution of the Adverse Event (if applicable)	Date	Day 0, follow-up day every 2 weeks until wound closure or end of study and 4 weeks after the wound closed

Collaborators and Investigators

• Sponsor: Fundacin Biomedica Galicia Sur

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2025
• Primary Completion (Actual): October 23, 2025
• Study Completion (Actual): November 6, 2025

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: November 27, 2025
• First Posted (Actual): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: ACE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No