A Phase 3 interventional study of Acetic Acid and Prontosan in Ulcer, Skin, sponsored by Consorci Sanitari de l'Alt Penedès i Garraf. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Consorci Sanitari de l'Alt Penedès i Garraf · Phase 3, Interventional, and Treatment
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.
61 studies on the registry are indexed under Skin Ulcer; 14 are open to participants now.
This study's planned enrollment of 104 is above the median of 62 across 51 interventional studies indexed under Skin Ulcer.
Browse Skin Ulcer studies →Consorci Sanitari de l'Alt Penedès i Garraf is the lead sponsor of 41 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants diagnosed with any of the following conditions:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Acetic Acid
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
Drug: Prontosan
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.
Also known as: Acetic Acid 2%
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.
Also known as: 0,1 % Undecilenamidopropil betaine, 0,1 % Polyhexanide
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.
Time frame: 8 weeks
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.
Time frame: 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.
Time frame: 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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
Plan to share: 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).
Supporting information: Study protocol, Informed consent form, Clinical study report
Time frame: After publication of main results of the study.
Access criteria: IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Mar 2028, 35 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 27, 2026: primary completion Mar 2027 → Mar 2028 and completion Mar 2027 → Mar 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Acetic Acid
Consorci Sanitari de l'Alt Penedès i Garraf