Acetic Acid 2% Solution for Skin Ulcers

NCT06297967 | Recruiting Phase 3

• 1 other identifier: CSAPG-33
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ulcer, Skin

Keywords

Skin Ulcer; Acetic Acid; Biofilms

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (8)

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

  4 weeks

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

  12 weeks

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

  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.

  8 weeks

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

  12 weeks

Study Arms (2)

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

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

Drug: Prontosan

Interventions

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.

Also known as: Acetic Acid 2%

Acetic Acid

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.

Also known as: 0,1 % Undecilenamidopropil betaine, 0,1 % Polyhexanide

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Consorci Sanitari de l'Alt Penedès i Garraf: lead

Study Sites (1)

Consorci Sanitari Alt'Pènedes i Garraf

Barcelona, Catalonia, 08810, Spain

RECRUITING

MeSH Terms

Conditions

Skin Ulcer

Interventions

Acetic Acid

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Marta De Vicente

  CSAPG

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta De Vicente

CONTACT

+34 9389316161; mdevicente@csapg.cat

Noemí Casaponsa

CONTACT

+34 938960025; recerca@csapg.cat

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 7, 2024
• Study Start: April 27, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• 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.

Locations

ES (1)