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

NCT07275385 | Completed

• 1 other identifier: ACE
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (34)

• 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

Study Arms (2)

control (non-ACE)

ACTIVE COMPARATOR

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)

ACE

EXPERIMENTAL

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)

Interventions

Advanced Cutaneous Evaluator (ACE) DEVICE

Nursing staff include the use of ACE in their routine clinical practice to support their chronic wound treatment decision-making process.

ACE

Control (non-ACE) OTHER

Professionals in the non-ACE group will carry out their usual clinical practice of chronic wound care.

control (non-ACE)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacin Biomedica Galicia Sur: lead

Study Sites (1)

Complexo Hospitalario Universitario de Pontevedra

Pontevedra, 36071, Spain

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Design

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

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 10, 2025
• Study Start: March 26, 2025
• Primary Completion: October 23, 2025
• Study Completion: November 6, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-11

Locations

ES (1)