Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06297967

Acetic Acid 2% Solution for Skin Ulcers

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Ulcer, Skin Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

Treatment and study plan

Acetic Acid

Drug

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.

Other names: Acetic Acid 2%

Prontosan

Drug

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.

Other names: 0,1 % Undecilenamidopropil betaine, 0,1 % Polyhexanide

Primary outcomes

  1. 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.

Secondary outcomes

  1. Percentage of participants with ulcer healing at 4 weeks from the start of treatment.

    Time frame: 4 weeks

    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.

  2. Percentage of participants with ulcer healing at 12 weeks from the start of treatment.

    Time frame: 12 weeks

    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.

  3. Time (days) to ulcer healing from the start of treatment.

    Time frame: up to 12 weeks

    The lesion will be considered fully healed when the surface is epithelialized. This will be confirmed by the nurse responsible for monitoring the lesion.

  4. 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

    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.

  5. Number of adverse reactions associated with the treatment, collected from the medical record.

    Time frame: 12 weeks

    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.

  6. The healthcare expenditure associated with each branch of the study

    Time frame: 12 weeks

    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.

  7. Change in ulcer area compared to baseline (percentage) at 4 weeks of treatment

    Time frame: 4 weeks

    The assessment of the ulcer will include measuring its area through digital planimetry.

  8. Change in ulcer area compared to baseline (percentage) at 12 weeks of treatment

    Time frame: 12 weeks

    The assessment of the ulcer will include measuring its area through digital planimetry.

Study contacts

Contact information is provided by the study sponsor or research team.

Marta De Vicente

CONTACT

[email protected]

+34 9389316161

Noemí Casaponsa

CONTACT

[email protected]

+34 938960025 ext. 43197

Sponsors and collaborators

Lead sponsor

Consorci Sanitari de l'Alt Penedès i Garraf

Other

Registry information

Official study title

Acetic Acid in Cutaneous Ulcers. A Randomized Controlled Trial

Acronym: ECA-AA

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 7, 2024
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.