Ulcer, SkinPhase 3ECA-AANCT06297967
Acetic Acid 2% Solution for Skin Ulcers
A Phase 3 study testing Acetic Acid and Prontosan in people with Ulcer, Skin, run by Consorci Sanitari de l'Alt Penedès i Garraf at 1 site in Spain.
Trial summary
The objective of this clinical trial is to assess the effectiveness of acetic acid in patients suffering from chronic cutaneous ulcers with biofilm. The primary question it seeks to address is whether acetic acid (as a 2% topical solution) is superior to the current standard treatment for chronic cutaneous ulcers with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcer, Skin
- What is being tested?
- Acetic Acid and Prontosan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSpain
- Study dates
- 27 Apr 2025to Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age.
- Continued care (hospital or outpatient) in one of the Consorci Sanitari Alt Penedes i Garraf (CSAPG) units.
- Presence of a cutaneous ulcer with biofilm, with an area of less than 120 cm2, and in any location (except the facial region).
- Plan to undergo treatment and follow-up of the lesion (at least 8 weeks) at the study center.
- Ability to cooperate in necessary evaluations.
- Informed consent for inclusion in the study, either from the participant themselves or from their legal representative.
Who cannot join
- Participants diagnosed with any of the following conditions:
- Ulcers with exposed bone tissue.
- Neoplastic-origin ulcers.
- Ulcers lasting more than 18 months.
- Participation in another clinical trial involving an experimental intervention during the period of the current trial and/or establishing a visit frequency incompatible with the current trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Consorci Sanitari Alt'Pènedes i Garraf
Barcelona, Catalonia, 08810
Marta De Vicente, +34 938931616, mdevicente@csapg.cat
Noemí Casaponsa, +34 938960025 ext. 43197, recerca@csapg.cat
About this study
Official title: Acetic Acid in Cutaneous Ulcers. A Randomized Controlled Trial
The objective of this clinical trial is to assess the effectiveness of acetic acid in patients suffering from chronic cutaneous ulcers with biofilm. The primary question it seeks to address is whether acetic acid (as a 2% topical solution) is superior to the current standard treatment for chronic cutaneous ulcers with biofilm at our center (Prontosan®).
Participants will be randomly assigned to receive either the acetic acid solution treatment or the standard current treatment.
- Conditions
- Ulcer, Skin
- Being tested
- Acetic Acid, Prontosan
- Keywords
- Skin Ulcer, Acetic Acid, Biofilms
- Medical subject headings
- Skin Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetic AcidDrug
Also called Acetic Acid 2%
The intervention treatment will consist of cleaning with water and soap, application of a compress soaked in 2% dilution of glacial acetic acid (CAS 64-19-7) for 15 minutes, irrigation with distilled water, application of peri-ulcer barrier cream or spray, and the application of ActicoatⓇ on the ulcer bed. Depending on the amount of exudate, more or less alginate will be added as a secondary dressing. A tertiary dressing of polyurethane foam or bandage will be applied according to the area and the nurse's discretion.
ProntosanDrug
Also called 0,1 % Undecilenamidopropil betaine, 0,1 % Polyhexanide
The treatment includes ulcer cleansing with water and soap, application of ProntosanⓇ compress for 15 minutes, subsequent irrigation with distilled water, application of peri-ulcer barrier cream or spray, and the application of ActicoatⓇ on the wound bed. More or less alginate will be applied depending on the amount of exudate. A tertiary dressing of polyurethane foam or bandage will be applied according to the area and the nurse's discretion.
| Study group | Role | What they receive |
|---|---|---|
| Acetic Acid | Experimental | Topic application of a Acetic Acid 2% solution for 15 min, typically administered every 24h. The frequency of the treatments may be modified according to the evolution of the lesion at the discretion of the nurse in charge of the treatments Receives: Drug: Acetic Acid |
| Control group | Active comparator | Topic application of Prontosan® for 15 min, typically administered every 24h. The frequency of the treatments may be modified according to the evolution of the lesion at the discretion of the nurse in charge of the treatments Receives: Drug: Prontosan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ulcer area compared to baseline (percentage) at 8 weeks of treatment
The assessment of the ulcer will include measuring its area through digital planimetry.
Measured: 8 weeks
Secondary outcomes (8)
Percentage of participants with ulcer healing at 4 weeks from the start of treatment.
The assessment of the ulcer will performed by the nurse responsible for monitoring the ulcer. The ulcer will be considered fully healed when the surface is epithelialized.
Measured: 4 weeks
Percentage of participants with ulcer healing at 12 weeks from the start of treatment.
The assessment of the ulcer will performed by the nurse responsible for monitoring the ulcer. The ulcer will be considered fully healed when the surface is epithelialized.
Measured: 12 weeks
Time (days) to ulcer healing from the start of treatment.
The lesion will be considered fully healed when the surface is epithelialized. This will be confirmed by the nurse responsible for monitoring the lesion.
Measured: up to 12 weeks
Changes in the wound bed at 8 weeks according to score of section 6 of the RESVECH2.0 ("Expected Results of the Assessment and Evaluation of Healing of Chronic Wounds" scale.
The evaluation of changes will be conducted by a trained nurse to apply the RESVECH 2.0 scale. The scores in Section 6 of the RESVECH scale range from 0 to 14. The higher the score, the greater the severity of the injury.
Measured: 8 weeks
Number of adverse reactions associated with the treatment, collected from the medical record.
The number of adverse reactions will be evaluated through the review of the participant's medical records by a trained member of the research team.
Measured: 12 weeks
The healthcare expenditure associated with each branch of the study
A descriptive analysis of healthcare expenditure associated with each study branch will be conducted using billing data from the center, which is linked to the insured individual's resource utilization.
Measured: 12 weeks
Change in ulcer area compared to baseline (percentage) at 4 weeks of treatment
The assessment of the ulcer will include measuring its area through digital planimetry.
Measured: 4 weeks
Change in ulcer area compared to baseline (percentage) at 12 weeks of treatment
The assessment of the ulcer will include measuring its area through digital planimetry.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start27 Apr 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcer, SkinStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i Garraf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marta De Vicente, Principal investigator, CSAPG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297967
- Sponsor's protocol ID
- CSAPG-33
- Acronym
- ECA-AA
- Status last verified
- Jun 2025
- First submitted
- 23 Feb 2024
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research proposels and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acetic Acid in Cutaneous Ulcers. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06297967
- Acronym / sponsor ID
- ECA-AA / CSAPG-33
- Conditions
- Ulcer, Skin
- Keywords
- Skin Ulcer, Acetic Acid, Biofilms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i GarrafUniversity, hospital or other
- Study start
- 27 Apr 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 7 Mar 2024 (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.
The objective of this clinical trial is to assess the effectiveness of acetic acid in patients suffering from chronic cutaneous ulcers with biofilm. The primary question it seeks to address is whether acetic acid (as a 2% topical solution) is superior to the current standard treatment for chronic cutaneous ulcers with biofilm at our center (Prontosan®).
Participants will be randomly assigned to receive either the acetic acid solution treatment or the standard current treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetic Acid | Experimental | Drug: Acetic AcidTopic application of a Acetic Acid 2% solution for 15 min, typically administered every 24h. The frequency of the treatments may be modified according to the evolution of the lesion at the discretion of the nurse in charge of the treatments |
| Control group | Active comparator | Drug: ProntosanTopic application of Prontosan® for 15 min, typically administered every 24h. The frequency of the treatments may be modified according to the evolution of the lesion at the discretion of the nurse in charge of the treatments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients over 18 years of age.
- Continued care (hospital or outpatient) in one of the Consorci Sanitari Alt Penedes i Garraf (CSAPG) units.
- Presence of a cutaneous ulcer with biofilm, with an area of less than 120 cm2, and in any location (except the facial region).
- Plan to undergo treatment and follow-up of the lesion (at least 8 weeks) at the study center.
- Ability to cooperate in necessary evaluations.
Key exclusion criteria (5 listed)
- Participants diagnosed with any of the following conditions:
- Participation in another clinical trial involving an experimental intervention during the period of the current trial and/or establishing a visit frequency incompatible with the current trial.
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 |
|---|---|---|
| Acetic AcidAlso: Acetic Acid 2%The intervention treatment will consist of cleaning with water and soap, application of a compress soaked in 2% dilution of glacial acetic acid (CAS 64-19-7) for 15 minutes, irrigation with distilled water, application of peri-ulcer barrier cream or spray, and the application of ActicoatⓇ on the ulcer bed. Depending on the amount of exudate, more or less alginate will be added as a secondary dressing. A tertiary dressing of polyurethane foam or bandage will be applied according to the area and the nurse's discretion. | Drug | Acetic Acid |
| ProntosanAlso: 0,1 % Undecilenamidopropil betaine, 0,1 % PolyhexanideThe treatment includes ulcer cleansing with water and soap, application of ProntosanⓇ compress for 15 minutes, subsequent irrigation with distilled water, application of peri-ulcer barrier cream or spray, and the application of ActicoatⓇ on the wound bed. More or less alginate will be applied depending on the amount of exudate. A tertiary dressing of polyurethane foam or bandage will be applied according to the area and the nurse's discretion. | Drug | Control group |
Primary outcome
Change in ulcer area compared to baseline (percentage) at 8 weeks of treatment
Time frame: 8 weeks
The assessment of the ulcer will include measuring its area through digital planimetry.
8 secondary outcomes
Percentage of participants with ulcer healing at 4 weeks from the start of treatment.
Time frame: 4 weeks
Percentage of participants with ulcer healing at 12 weeks from the start of treatment.
Time frame: 12 weeks
Time (days) to ulcer healing from the start of treatment.
Time frame: up to 12 weeks
Changes in the wound bed at 8 weeks according to score of section 6 of the RESVECH2.0 ("Expected Results of the Assessment and Evaluation of Healing of Chronic Wounds" scale.
Time frame: 8 weeks
Number of adverse reactions associated with the treatment, collected from the medical record.
Time frame: 12 weeks
The healthcare expenditure associated with each branch of the study
Time frame: 12 weeks
Change in ulcer area compared to baseline (percentage) at 4 weeks of treatment
Time frame: 4 weeks
Change in ulcer area compared to baseline (percentage) at 12 weeks of treatment
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: Yes. IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research proposels and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
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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.
Marta De Vicente principal investigator
CSAPG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetic Acid and Prontosan in people with Ulcer, Skin, run by Consorci Sanitari de l'Alt Penedès i Garraf 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 26 Jun 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marta De Vicente (+34 9389316161, mdevicente@csapg.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ulcer area compared to baseline (percentage) at 8 weeks of treatment (time frame: 8 weeks). 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 26 Jun 2025.