Wounds and InjuriesACENCT07275385
Advanced Cutaneous Evaluator (ACE): Estimation of Clinical and Economic Impact
A study testing Advanced Cutaneous Evaluator (ACE) in people with Wounds and Injuries and Wound Complication, run by Fundacin Biomedica Galicia Sur at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Wounds and Injuries, Wound Complication
- What is being tested?
- Advanced Cutaneous Evaluator (ACE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteSpain
- Study dates
- 26 Mar 2025to 6 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Wounds and Injuries, Wound Complication
- Being tested
- Advanced Cutaneous Evaluator (ACE), Control (non-ACE)
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Advanced Cutaneous Evaluator (ACE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment group
ACE or non-ACE
Measured: Day 0
Health center
Open Field
Measured: Day 0
Training of healthcare professionals
Academic training of healthcare professionals
Measured: 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
Measured: Day 0, at the start of the professional's participation
SUS
Score obtained after completing the System Usability Scale questionnaire
Measured: At month 1, month 3 and month 5 after the professional's participation
NASA TLX
Score obtained after completing the NASA TLX questionnaire
Measured: At month 1, month 3 and month 5 after the professional's participation
Patient age
Patient's age in years
Measured: Day 0, at the start of recruitment
Gender
Male or female
Measured: 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.
Measured: Day 0, at the start of recruitment
Allergies
Open field
Measured: Day 0, at the start of recruitment
Recurrent medication
Indicate, if applicable, the following option(s): Corticosteroids, NSAIDs, anticoagulants, others.
Measured: 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.
Measured: Day 0, at the start of recruitment
Number of wounds in the same patient
Number
Measured: Day 0 and follow-up day every 2 weeks until end of recruitment
Wound location
Open field
Measured: Day 0, at the start of recruitment
Date of first consultation
Date
Measured: Day 0, at the start of recruitment
Date of wound closure
Date
Measured: Day of wound closure after follow-up
Date of loss to follow-up (if applicable)
Date
Measured: Day of loss to follow-up after follow-up
Reason of loss to follow-up (if applicable)
Open field
Measured: Day of loss to follow-up after follow-up
Date of treatment decision
Date
Measured: Day 0 and follow-up day every 2 weeks until wound closure or end of study
Use of ACE?
Yes or No
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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.
Measured: Day 0 and follow-up day every 2 weeks until wound closure or end of study
Date of Adverse Event (if applicable)
Date
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Day 0, follow-up day every 2 weeks until wound closure or end of study and 4 weeks after the wound closed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start26 Mar 2025
- Primary completion23 Oct 2025
- Study completion6 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacin Biomedica Galicia Sur
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275385
- Sponsor's protocol ID
- ACE
- Acronym
- ACE
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Cutaneous Evaluator (ACE): Estimation of Clinical and Economic Impact
- ClinicalTrials.gov ID
- NCT07275385
- Acronym / sponsor ID
- ACE / ACE
- Conditions
- Wounds and Injuries, Wound Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Fundacin Biomedica Galicia SurUniversity, hospital or other
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- 23 Oct 2025 (actual)
- Study completion
- 6 Nov 2025 (actual)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control (non-ACE) | Active comparator | Other: 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. |
| ACE | Experimental | Device: Advanced Cutaneous Evaluator (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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | ACE |
| Control (non-ACE)Professionals in the non-ACE group will carry out their usual clinical practice of chronic wound care. | Other | control (non-ACE) |
Primary outcome
Treatment group
Time frame: Day 0
ACE or non-ACE
Health center
Time frame: Day 0
Open Field
Training of healthcare professionals
Time frame: Day 0, at the start of the professional's participation
Academic training of healthcare professionals
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
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
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
Patient age
Time frame: Day 0, at the start of recruitment
Patient's age in years
Gender
Time frame: Day 0, at the start of recruitment
Male or female
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.
Allergies
Time frame: Day 0, at the start of recruitment
Open field
Recurrent medication
Time frame: Day 0, at the start of recruitment
Indicate, if applicable, the following option(s): Corticosteroids, NSAIDs, anticoagulants, others.
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.
Number of wounds in the same patient
Time frame: Day 0 and follow-up day every 2 weeks until end of recruitment
Number
Wound location
Time frame: Day 0, at the start of recruitment
Open field
Date of first consultation
Time frame: Day 0, at the start of recruitment
Date
Date of wound closure
Time frame: Day of wound closure after follow-up
Date
Date of loss to follow-up (if applicable)
Time frame: Day of loss to follow-up after follow-up
Date
Reason of loss to follow-up (if applicable)
Time frame: Day of loss to follow-up after follow-up
Open field
Date of treatment decision
Time frame: Day 0 and follow-up day every 2 weeks until wound closure or end of study
Date
Use of ACE?
Time frame: Day 0 and follow-up day every 2 weeks until wound closure or end of study
Yes or No
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
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
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
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
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
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
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).
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.
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
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
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.
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.
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
Related trials for Wounds and Injuries
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advanced Cutaneous Evaluator (ACE) in people with Wounds and Injuries and Wound Complication, run by Fundacin Biomedica Galicia Sur at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment group (time frame: Day 0). The study lists 34 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.