2% acetic acid solution for chronic skin ulcers with biofilm
Official title: Acetic Acid in Cutaneous Ulcers. A Randomized Controlled Trial
Run by Consorci Sanitari de l'Alt Penedès i Garraf · NCT06297967 · Data updated 2026-11-12
This trial will try a 2% topical acetic acid solution to see if it heals chronic skin ulcers with biofilm better than the current Prontosan® treatment in adults cared for at the center.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 104 (estimated) |
| Sponsor | Consorci Sanitari de l'Alt Penedès i Garraf Academic / other |
| Locations | 1 site (Barcelona, Catalonia) |
| Status | Recruiting |
| Started | April 27, 2025 |
| Main results expected | March 2028 |
| Study ends | March 2028 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT06297967 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults receiving care at Consorci Sanitari Alt Penedès i Garraf who have a non-facial cutaneous ulcer with biofilm under 120 cm², can attend follow-up visits, and can provide informed consent are ideal candidates.
✕Probably not a fit
Patients with ulcers exposing bone, ulcers of neoplastic origin, ulcers present for more than 18 months, or those unable to receive follow-up at the study center are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 3 randomized interventional trial will assign adult patients with chronic cutaneous ulcers containing biofilm to receive either a 2% acetic acid topical solution or the center's standard treatment, Prontosan®. Eligible ulcers must be under 120 cm², not located on the face, and patients must be followed at the study center for at least eight weeks. Key exclusions include ulcers with exposed bone, ulcers of neoplastic origin, and ulcers present for more than 18 months. The primary aim is to determine whether the acetic acid arm is superior to Prontosan® for managing biofilm-associated chronic ulcers at this center.
Why it matters
Potential benefit: If successful, this could provide a low-cost topical option that more effectively clears biofilm and promotes healing of chronic skin ulcers.
How similar studies have gone: Smaller clinical reports and observational data suggest topical acetic acid can reduce wound bacteria and biofilm, but large randomized Phase 3 comparisons against products like Prontosan® are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Participants diagnosed with any of the following conditions: 1. Ulcers with exposed bone tissue. 2. Neoplastic-origin ulcers. 3. 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.
Where it's running
-
Consorci Sanitari Alt'Pènedes i Garraf
Barcelona, Catalonia, Spain Recruiting
Study contacts
- Principal investigator: Marta De Vicente — Csapg
- Study coordinator: Marta De Vicente
- Email: mdevicente@csapg.cat
- Phone: +34 9389316161
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.