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Completed

NCT Number: NCT07275385

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

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.

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Key information

Conditions

Wounds and Injuries Wound Complication

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Complexo Hospitalario Universitario de Pontevedra

Pontevedra, 36071, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Control (non-ACE)

Other

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

Primary outcomes

  1. Treatment group

    Time frame: Day 0

    ACE or non-ACE

  2. Health center

    Time frame: Day 0

    Open Field

  3. Training of healthcare professionals

    Time frame: Day 0, at the start of the professional's participation

    Academic training of healthcare professionals

  4. Years of experience of healthcare professionals

    Time frame: Day 0, at the start of the professional's participation

    Years of experience of healthcare professionals in healing chronic wounds

  5. SUS

    Time frame: At month 1, month 3 and month 5 after the professional's participation

    Score obtained after completing the System Usability Scale questionnaire

  6. NASA TLX

    Time frame: At month 1, month 3 and month 5 after the professional's participation

    Score obtained after completing the NASA TLX questionnaire

  7. Patient age

    Time frame: Day 0, at the start of recruitment

    Patient's age in years

  8. Gender

    Time frame: Day 0, at the start of recruitment

    Male or female

  9. Diseases

    Time frame: Day 0, at the start of recruitment

    Indicate, if applicable, the following option(s): DM I or II, venous and/or arterial insufficiency, ischemia, obesity, osteomyelitis, diabetic neuropathy, others.

  10. Allergies

    Time frame: Day 0, at the start of recruitment

    Open field

  11. Recurrent medication

    Time frame: Day 0, at the start of recruitment

    Indicate, if applicable, the following option(s): Corticosteroids, NSAIDs, anticoagulants, others.

  12. History of chronic wounds

    Time frame: Day 0, at the start of recruitment

    Indicate, if applicable, etiology, highest classification, location, and if healed, the approximate closing date.

  13. Number of wounds in the same patient

    Time frame: Day 0 and follow-up day every 2 weeks until end of recruitment

    Number

  14. Wound location

    Time frame: Day 0, at the start of recruitment

    Open field

  15. Date of first consultation

    Time frame: Day 0, at the start of recruitment

    Date

  16. Date of wound closure

    Time frame: Day of wound closure after follow-up

    Date

  17. Date of loss to follow-up (if applicable)

    Time frame: Day of loss to follow-up after follow-up

    Date

  18. Reason of loss to follow-up (if applicable)

    Time frame: Day of loss to follow-up after follow-up

    Open field

  19. Date of treatment decision

    Time frame: Day 0 and follow-up day every 2 weeks until wound closure or end of study

    Date

  20. Use of ACE?

    Time frame: Day 0 and follow-up day every 2 weeks until wound closure or end of study

    Yes or No

  21. Wound size

    Time frame: Day 0 and follow-up day every 2 weeks until wound closure or end of study

    Width, length and depth (if applicable) measured in cm

  22. Tissues in the wound bed

    Time frame: Day 0 and follow-up day every 2 weeks until wound closure or end of study

    Indicate the following option(s): Necrotic, Sloughing, Granulation, Epithelial, Intact skin with erythema

  23. Dominant tissue in the wound bed

    Time frame: Day 0 and follow-up day every 2 weeks until wound closure or end of study

    Select one of the options: Necrotic, Sloughing, Granulation, Epithelial, Intact skin with erythema

  24. Exudate level

    Time frame: Day 0 and follow-up day every 2 weeks until wound closure or end of study

    Select one of the options: 0 none, 1 scarce, 2 moderate, 3 abundant

  25. Condition of the perilesional skin

    Time frame: Day 0 and follow-up day every 2 weeks until wound closure or end of study

    Indicate the following option(s): Macerated, Erythema or inflammation, Eczema, Fragile skin

  26. Etiology of the wound

    Time frame: Day 0 and follow-up day every 2 weeks until wound closure or end of study

    Select one of the options: LESCAH, Diabetic foot, Burn, Arterial, Pressure, Venous, Not determined

  27. Category of the wound

    Time frame: Day 0 and follow-up day every 2 weeks until wound closure or end of study

    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).

  28. Applied products

    Time frame: Day 0 and follow-up day every 2 weeks until wound closure or end of study

    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.

  29. Date of Adverse Event (if applicable)

    Time frame: Day 0, follow-up day every 2 weeks until wound closure or end of study and 4 weeks after the wound closed

    Date

  30. Adverse Event classification (if applicable)

    Time frame: Day 0, follow-up day every 2 weeks until wound closure or end of study and 4 weeks after the wound closed

    Indicate the following option(s): Severe, Not severe, Expected, Unexpected, Related, Possibly related, Not related

  31. Description of Adverse Event (if applicable)

    Time frame: Day 0, follow-up day every 2 weeks until wound closure or end of study and 4 weeks after the wound closed

    Open field describing the event, device deficiency (if applicable), clinical signs, clinical impact, patient action/treatment/outcome.

  32. Measure taken after Adverse Event (if applicable)

    Time frame: Day 0, follow-up day every 2 weeks until wound closure or end of study and 4 weeks after the wound closed

    Select one of the options: None, Change of treatment, Other.

  33. Outcome of the Adverse Event (if applicable)

    Time frame: Day 0, follow-up day every 2 weeks until wound closure or end of study and 4 weeks after the wound closed

    Select one of the options: Recovered, Recovering, Not recovered, Recovered with sequelae, Fatal, Unknown

  34. Date of resolution of the Adverse Event (if applicable)

    Time frame: Day 0, follow-up day every 2 weeks until wound closure or end of study and 4 weeks after the wound closed

    Date

Sponsors and collaborators

Lead sponsor

Fundacin Biomedica Galicia Sur

Other

Registry information

Acronym: ACE

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 10, 2025
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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