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Clinical Trials in Spain / NCT06297967
Recruiting Phase 3

Acetic Acid 2% Solution for Skin Ulcers

NCT06297967 · tracked via the Priya Life Science Spain tracker
Sponsor
Consorci Sanitari de l'Alt Penedès i Garraf
Phase
Phase 3
Started
2025-04-27
Last updated
2025-06-26

Condition(s) studied

Ulcer, Skin

Investigational drug(s) / intervention(s)

Acetic AcidProntosan →

Acetic Acid: 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.

Prontosan: 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 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 biofilm at our center (Prontosan®).

Participants will be randomly assigned to receive either the acetic acid solution treatment or the standard current treatment.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change in ulcer area compared to baseline (percentage) at 8 weeks of treatment — 8 weeks
    The assessment of the ulcer will include measuring its area through digital planimetry.

Trial sites (1)

FacilityCityRegionStatus
Consorci Sanitari Alt'Pènedes i Garraf Barcelona Catalonia Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06297967 on ClinicalTrials.gov ↗ ← All trials in Spain