Clinical trial NCT06297967: Acetic Acid 2% Solution for Skin Ulcers
Official title: Acetic Acid in Cutaneous Ulcers. a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Ulcer, Skin
Keywords: Skin Ulcer
Acetic Acid
Biofilms
Lead sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in ulcer area compared to baseline (percentage) at 8 weeks of treatment
timeFrame: 8 weeks
Secondary outcomes:
measure: Percentage of participants with ulcer healing at 4 weeks from the start of treatment.
timeFrame: 4 weeks
measure: Percentage of participants with ulcer healing at 12 weeks from the start of treatment.
timeFrame: 12 weeks
measure: Time (days) to ulcer healing from the start of treatment.
timeFrame: up to 12 weeks
measure: 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.
timeFrame: 8 weeks
measure: Number of adverse reactions associated with the treatment, collected from the medical record.
timeFrame: 12 weeks
measure: The healthcare expenditure associated with each branch of the study
timeFrame: 12 weeks
measure: Change in ulcer area compared to baseline (percentage) at 4 weeks of treatment
timeFrame: 4 weeks
measure: Change in ulcer area compared to baseline (percentage) at 12 weeks of treatment
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Consorci Sanitari Alt'Pènedes i Garraf
state: Cataluña
Study officials:
affiliation: CSAPG
name: Marta De Vicente
role: PRINCIPAL_INVESTIGATOR
References: